title: Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery

summary: An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment

location_country:
Germany
Italy
United Kingdom
Sweden
Austria
Spain
France

location_facility: 1160.84.04947 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03902 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3404 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04948 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4601 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4301 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3311 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3313 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3319 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04929 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03908 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4603 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4604 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04408 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04407 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04405 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3323 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3322 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04913 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3335 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3402 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3403 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04914 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3316 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03909 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03904 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3401 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3324 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3305 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3303 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3410 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3312 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3326 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3320 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3412 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04403 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3302 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4922 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04938 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04401 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3306 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3307 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3409 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04927 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04946 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3314 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4310 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3310 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04903 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3405 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04902 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3332 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3334 Boehringer Ingelheim Investigational Site


title: Multicenter, Randomized Study Comparing the Efficacy and Safety of Two Doses of Thalidomide (100 mg/Day Versus 400 mg/Day) in the Treatment of Subjects With Refractory or Relapsed Multiple Myeloma.

summary: The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Yakoub-Agha I, Mary JY, Hulin C, Doyen C, Marit G, Benboubker L, Voillat L, Moreau P, Berthou C, Stoppa AM, Maloisel F, Rodon P, Dib M, Pegourie B, Casassus P, Slama B, Damaj G, Zerbib R, Harousseau JL, Mohty M, Facon T; Intergroupe Francophone du Myelome (IFM). Low-dose vs. high-dose thalidomide for advanced multiple myeloma: a prospective trial from the Intergroupe Francophone du Myelome. Eur J Haematol. 2012 Mar;88(3):249-59. doi: 10.1111/j.1600-0609.2011.01729.x. Epub 2012 Jan 4.

lead_sponsor: Celgene

location_country: Belgium France

location_facility: Centre Hospitalier de Blois - Unité d'Onco-Hématologie

location_facility: Centre Hospitalier Laennec - Service de Médecine A

location_facility: Centre Hospitalier H. Duffaut - Hematologie

location_facility: CHR Hôp N.D. de Bon Secours - Service de Médecine A

location_facility: CENTRE HOSPITALIER DEPARTEMENTAL - Sce Médecine A

location_facility: Centre Hospitalier La Rochelle - Unité d'Oncologie Médicale

location_facility: Centre Hospitalier D'Annecy - Service d'oncohématologie

location_facility: Centre Hospitalier Chubert - Médecine Interne

location_facility: Centre Henri Becquerel - Service Hématologie

location_facility: Hopital Avicenne - Medecine Interne/Hematologie

location_facility: Centre Hospitalier General - Medecine Interne

location_facility: Centre Hospitalier - Service de Rhumatologie

location_facility: C.H.U. de Saint Etienne - Hôpital Bellevue - Sce Rhumatologie

location_facility: CHU Hôpital Brabois - Médecine interne-Hématologie

location_facility: Centre Hospitalier - Service Hematologie

location_facility: HOPITAL HAUTEPIERRE - Service Rhumatologie

location_facility: HOPITAL JEAN MINJOZ - Médecine interne/Hématologie

location_facility: Centre Hospitalier - Service de Médecine 7

location_facility: CHRU Hôtel Dieu, Service des Maladies du Sang

location_facility: Centre Hospitalier Général - Service d'Hématologie

location_facility: Centre Hospitalier Du Dr Duschene - Hematologie

location_facility: INSTITUT PAOLI CALMETTE - Unité transplantation

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.

ReferenceType: result

ReferenceCitation: Becouarn Y, Senesse P, Thezenas S, Boucher E, Adenis A, Cany L, Jacob JH, Cvitkovic F, Montoto-Grillot C, Ychou M; Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. Ann Oncol. 2007 Dec;18(12):2000-5. doi: 10.1093/annonc/mdm379. Epub 2007 Sep 4.

lead_sponsor: UNICANCER

location_facility: Pole Sante Sarthe et Loir Hopital Pierre Daguet

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Centre Hospitalier General Lucien Hussel

location_facility: Centre Hospitalier de L' Agglomeration Montargoise


type: Other Identifier

title: Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer.

design_allocation: Non-Randomized

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospital Regional Universitaire de Limoges


title: Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse

summary:
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

ReferenceCitation: Fizazi K, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Flechon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Lagrange JL, Chinet-Charrot P, Linassier C, Deplanque G, Beuzeboc P, Geneve J, Davin JL, Tournay E, Culine S. A phase III trial of docetaxel-estramustine in high-risk localised prostate cancer: a planned analysis of response, toxicity and quality of life in the GETUG 12 trial. Eur J Cancer. 2012 Jan;48(2):209-17. doi: 10.1016/j.ejca.2011.10.015. Epub 2011 Nov 24.

ReferenceCitation: Fizazi K, Lesaunier F, Delva R, et al.: A phase III trial of docetaxel-estramustine in high-risk localized prostate cancer (GETUG 12 trial): design, tolerance, response, and quality of life (QOL). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-7, 2010.

ReferenceCitation: Fizazi K, Gravis G, Culine S: The GETUG 12 trial, a phase III randomized trial of docetaxel-estramustine in high-risk localized prostate cancer: clinical design and current status. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-153, 2006.

ReferenceType: derived

ReferenceCitation: Fizazi K, Faivre L, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Flechon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Chinet-Charrot P, Legouffe E, Lagrange JL, Linassier C, Deplanque G, Beuzeboc P, Davin JL, Martin AL, Habibian M, Laplanche A, Culine S. Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial. Lancet Oncol. 2015 Jul;16(7):787-94. doi: 10.1016/S1470-2045(15)00011-X. Epub 2015 May 28.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

collaborators: Sanofi AstraZeneca

sponsor_collaborators: UNICANCER Sanofi AstraZeneca

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospitalier General de Mont de Marsan


title: Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer.

ReferenceCitation: Kerbrat P, Desmoulins I, Roca L, Levy C, Lortholary A, Marre A, Delva R, Rios M, Viens P, Brain E, Serin D, Edel M, Debled M, Campone M, Mourret-Reynier MA, Bachelot T, Foucher-Goudier MJ, Asselain B, Lemonnier J, Martin AL, Roche H. Optimal duration of adjuvant chemotherapy for high-risk node-negative (N-) breast cancer patients: 6-year results of the prospective randomised multicentre phase III UNICANCER-PACS 05 trial (UCBG-0106). Eur J Cancer. 2017 Jul;79:166-175. doi: 10.1016/j.ejca.2017.03.004. Epub 2017 May 11.

location_facility: Polyclinique Du Parc Centre Maurice Tubiana

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron

location_facility: Centre Hospitalier General Andre Boulloche

location_facility: Centre Hospital General Robert Ballanger


title: Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).

ReferenceCitation: Mancini J, Genre D, Dalenc F, Maylevin F, Martin AL, Viens P, Julian-Reynier C. Transparency in the presentation of trial results may not increase patients' trust in medical researchers. Clin Trials. 2012 Feb;9(1):90-3. doi: 10.1177/1740774511427063. Epub 2011 Nov 2.

ReferenceCitation: Roché H, Allouache D, Romieu G, et al.: Five-year analysis of the FNCLCC-PACS04 trial: FEC100 vs ED75 for the adjuvant treatment of node positive breast cancer. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-602, 2009.

ReferenceCitation: Spielmann M, Roche H, Delozier T, Canon JL, Romieu G, Bourgeois H, Extra JM, Serin D, Kerbrat P, Machiels JP, Lortholary A, Orfeuvre H, Campone M, Hardy-Bessard AC, Coudert B, Maerevoet M, Piot G, Kramar A, Martin AL, Penault-Llorca F. Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial. J Clin Oncol. 2009 Dec 20;27(36):6129-34. doi: 10.1200/JCO.2009.23.0946. Epub 2009 Nov 16.

ReferenceCitation: Spielmann M, Roché H, Humblet Y, et al.: 3-year follow-up of trastuzumab following adjuvant chemotherapy in node positive HER2-positive breast cancer patients: results of the PACS-04 trial. [Abstract] Breast Cancer Res Treat 106 (1): A-72, S19, 2007.

ReferenceCitation: Spielmann M, Roché H, Delozier T, et al.: Safety analysis from PACS 04--a phase III trial comparing 6 cycles of FEC100 with 6 cycles of ET75 for node-positive early breast cancer patients, followed by sequential trastuzumab in HER2+patients: preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-632, 2006.

ReferenceCitation: O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors </= 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier Regional Metz Thionville


title: Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.

status: Terminated

status_simplified: Unknown


type: Registry Identifier

title: Conformational, Curative Ratiotherapy For Prostate Cancer (NO, N-): Phase III Multicenter Study Of The Contribution To Survival Without Clinical Or Biological Change With A Dose Variation Of 15% (80 Gy VS 70 Gy)

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have localized prostate cancer.

ReferenceCitation: Beckendorf V, Guerif S, Le Prise E, Cosset JM, Bougnoux A, Chauvet B, Salem N, Chapet O, Bourdain S, Bachaud JM, Maingon P, Hannoun-Levi JM, Malissard L, Simon JM, Pommier P, Hay M, Dubray B, Lagrange JL, Luporsi E, Bey P. 70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial. Int J Radiat Oncol Biol Phys. 2011 Jul 15;80(4):1056-63. doi: 10.1016/j.ijrobp.2010.03.049. Epub 2010 Dec 14.

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Hopital Jules Courmont - Centre Hospitalier Lyon Sud

intervention_type: Radiation


title: Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct.

status: Unknown status

ReferenceCitation: Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31. doi: 10.1200/JCO.2006.07.5663.

ReferenceCitation: Andre T, Noirclerc M, Hammel P, Meckenstock R, Landi B, Cattan S, Selle F, Codoul JF, Guerrier-Parmentier B, Mokhtar R, Louvet C; GERCOR. Phase II study of leucovorin, 5-fluorouracil and gemcitabine for locally advanced and metastatic pancreatic cancer (FOLFUGEM 2). Gastroenterol Clin Biol. 2004 Aug-Sep;28(8-9):645-50. doi: 10.1016/s0399-8320(04)95042-7.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_country: Luxembourg France

location_facility: L'Institut Mutualiste Montsouris Jourdan

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

location_facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud


title: Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.

PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.

sponsor_collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie


title: Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.

location_facility: Hopital Desgenettes - Service de Medecine Interne


title: First Line Treatment of Stage IIIb/IV Non Small Cell (NSC) Lung Cancer With a Bimonthly Administration of a Combination of Cisplatin-Gemcitabine

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cisplatin with gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

location_facility: Centre Hospitalier Departmental Felix Guyon


title: Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.

ReferenceCitation: Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, Bouche O, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009 Apr;20(4):674-80. doi: 10.1093/annonc/mdn680. Epub 2009 Jan 29.

ReferenceCitation: Cote JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, Thirouard AS, Selves J, Laurent-Puig P, Ychou M. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007 Jun 1;13(11):3269-75. doi: 10.1158/1078-0432.CCR-06-2290. Epub 2007 May 17.

collaborators: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier de Bourgoin - Jallieu

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: Intensive Chemotherapy With Peripheral Blood Stem Cell Support for Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have small cell lung cancer.

enrollment_type: Anticipated


title: Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow patients to tolerate higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have germ cell tumors that have not responded to previous chemotherapy.

location_facility: Hopital d'Instruction des Armees du Val de Grace


title: Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer.

ReferenceCitation: Tournier-Rangeard L, Mercier M, Peiffert D, Gerard JP, Romestaing P, Lemanski C, Mirabel X, Pommier P, Denis B. Radiochemotherapy of locally advanced anal canal carcinoma: prospective assessment of early impact on the quality of life (randomized trial ACCORD 03). Radiother Oncol. 2008 Jun;87(3):391-7. doi: 10.1016/j.radonc.2007.12.004. Epub 2008 Jan 11.

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier General de Saint Nazaire

location_facility: Centre Hospital Regional Universitaire de Limoges


title: Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.

ReferenceCitation: Pommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, Pabot du Chatelard PM, Bernier V, Voirin N, Perol D, Carrie C. Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007 Dec 1;25(34):5366-73. doi: 10.1200/JCO.2006.10.5171.

ReferenceCitation: Pommier P, Perol D, Lagrange J, et al.: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG 01 trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-33, S19, 2005.

location_facility: Clinique de la Sauvegarde - Clinique Jeanne D'Arc


title: A RANDOMIZED, MULTI-CENTRE PHASE III TRIAL TO EVALUATE THE ROLE OF INTENSIFIED THERAPY WITH AUTOLOGOUS TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS IN ADVANCED OR METASTATIC BREAST CANCER RESPONDING TO INDUCTION CHEMOTHERAPY

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. It is not yet known if high dose chemotherapy plus peripheral stem cell transplantation is more effective than standard therapy for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation with that of standard therapy in treating women who have locally recurrent or metastatic breast cancer.

ReferenceCitation: Biron P, Durand M, Roche H, Delozier T, Battista C, Fargeot P, Spaeth D, Bachelot T, Poiget E, Monnot F, Tanguy ML, Cure H. Pegase 03: a prospective randomized phase III trial of FEC with or without high-dose thiotepa, cyclophosphamide and autologous stem cell transplantation in first-line treatment of metastatic breast cancer. Bone Marrow Transplant. 2008 Mar;41(6):555-62. doi: 10.1038/sj.bmt.1705935. Epub 2007 Nov 26.

ReferenceCitation: Biron P, Durand M, Roche H, et al.: High dose thiotepa (TTP), cyclophosphamide (CPM) and stem cell transplantation after 4 FEC 100 compared with 4 FEC alone allowed a better disease free survival but the same overall survival in first line chemotherapy for metastatic breast cancer: results of the PEGASE 03 French protocole. [Abstract] Proceedings of the American Society of Clinical Oncology A-167, 2002.

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Federation Nationale des Centres de Lutte Contre le Cancer

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for small cell lung cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy using two different doses of cyclophosphamide followed by alternating chemotherapy and radiation therapy in treating patients with small cell lung cancer.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre Hospitalier Sud Francilien - Site Corbeil

lead_sponsor_type: academique


title: Randomized Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves

acronym: REPEAT

summary:
Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Available drug treatments have moderate efficacy whereas surgical lung volume reduction can improve exercise capacity when offered to a very selected population but at the cost of significant morbidity and mortality.

Endoscopic Lung Volume reduction with ZEPHYR® valves improves respiratory function at rest, exercise tolerance and quality of life in patients with little or no interlobar collateral ventilation.

If this technique has therefore proven its effectiveness, it is not devoid of complications and is notably responsible for pneumothorax in 27% of cases. The management of this complication is clearly codified, ranging from patient monitoring to the removal of one or more valves. It is therefore a subject of major concern for multiple reasons: high incidence, lengthening of hospital stay, increase in the overall cost of care, potential loss of benefit for the patient in the event of permanent withdrawal. valves and above all a potentially fatal event.

A new strategy for implanting ZEPHYR® valves in two stages has been developed in Limoges University Hospital. This innovative algorithm has been evaluated in several non-comparative single or multicenter studies. In those studies, pneumothorax' rate secondary to lung volume reduction with endobronchial valves is rated between 4.5 and 12%. The efficacy of the treatment appears to be comparable with the data found in the trials evaluating in which the entire lobe was treated in one procedure. Moreover, despite two procedures, there does not seem to be any increased risk of occurrence of other complications. Finally, the systematic scheduling of a thoracic computed tomography between the two procedures showed that 26.6% of patients presented a reduction in volume greater than 350mL despite incomplete treatment.

These data seem promising but no direct comparison with standard one-step treatment has ever been conducted so far.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Limoges

location_facility:
Hopital Saint Joseph
chu de Toulouse
CHU de Nice
CHU de Lille
CHU de Dijon
chu de Grenoble
CHU de Limoges
APHP
CHU de Brest
chu de Strasbourg
CHU de Rouen
CHU de Bordeaux
APHM
Hopital Foch

intervention_type: Procedure

status_simplified: Ongoing


title: Screening and Epidemiology of Hepato-pancreato-biliary Abnormalities in Fibrous Dysplasia of Bone /McCune Albright Syndrome: the TIM-DYS Study

acronym: TIM-DYS

summary:
Fibrous dysplasia of bone /McCune Albright syndrome (FD/MAS) is a rare bone disease caused by somatic mutations in GNAS gene. This GNAS mutation predisposes to cancers, including breast cancer, thyroid cancer, chondrosarcoma and osteosarcoma, as well as biliary tract anomalies, liver-tumors or pancreatic tumors - IPMNs. Intraductal papillary and mucinous neoplasms of the pancreas (IPMN) are cystic intraepithelial ductal lesions developed at the expense of pancreatic ducts. They are pre-cancerous lesions, requiring monitoring and, in case of progression or malignant degeneration, surgical resection. Pancreatic MRI screening of patients with polyostotic FD and MAS is recommended.

The aim of this study is to investigate the epidemiology and characteristics of these hepato-pancreato-biliary abnormalities (prevalence, age of onset, degeneration), based on magnetic resonance imaging (MRI) realized during the follow-up of patients with FD/MAS treated in a French FD expert center.

A better understanding of these IPMNs and other digestive abnormalities will enable clinicians to improve the management and monitoring in this high-risk population.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon

location_facility: Service Rhumatologie, pavillon F Hopital E. Herriot

location_facility: Assistance Publique - Hopitaux de Paris (Ap-Hp)

location_facility: Assistance Publique - Hopitaux de Marseille (Ap-Hm

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

intervention_type: Other


title: Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated With Targeted Therapy: the Model of Chronic Myeloid Leukemia Treated With Tyrosine Kinase Inhibitors.

acronym: BIO-TIMER

summary: French prospective multicenter, open-label study involving newly diagnosed CML patients. Two assessments will be performed during the follow-up of these patients: individual frailty using geriatric tools and individual biological aging determined by DNA methylation analysis.

status: Recruiting

primary_purpose: Other

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Groupe Hospitalier Paris Saclay - Site de Bicêtre

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

intervention_type: Biological


title: Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa

acronym: DEMO

summary:
Head and neck cancers represent more than 500,000 cases per year worldwide, and often involve post-treatment relapse. The oral cavity is the most frequent site, but early disease stages are still insufficiently characterised and poorly detected. The study's aim is to better understand the oral mucosa somatic evolution, and how it can give rise to oral squamous cell carcinoma (OSCC).

This is a multi-centric, descriptive, non-interventional cohort in healthy adult subjects. The aim of the study is to detect the presence of OSCC driver gene mutations in healthy subjects' oral mucosa, quantify whether they provide cells with a selective advantage, and study the impact of tobacco and alcohol consumption on the mutational load. This study will not allow to identify potential malignant cells, and will be usable for diagnostic purposes.

time_perspective: Cross-Sectional

location_facility: Unité de chirurgie et médecine orales (UCMO) - HCL - Hôpital Edouard Herriot- Pavillon R

location_facility: Centre de Consultations et de Traitements Dentaires HCL


title: Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer: a Multicenter Randomized Controlled Trial

acronym: COG STIM 2

summary:
Investigator propose the first French randomized comparative study to assess the efficacy of a remotely supervised online cognitive stimulation program, compared to an unsupervised online cognitive exercise intervention, in reducing cognitive complaints in localized breast cancer patients after adjuvant chemotherapy. Previous randomized studies have confirmed the effectiveness of online cognitive stimulation programs compared to standard care. The study seeks to determine the added value of remote supervision by a neuropsychologist. The control group will have access to the same online cognitive exercises as the experimental group but without supervision. Investigator has chosen not to include a wait-list group as it would be unethical to deny patients with cognitive complaints the opportunity to participate in an intervention expected to benefit them. The secondary objective is to evaluate the benefit of the supervised digitalized cognitive intervention on objective cognitive impairment.

The research hypothesis is that incorporating personalized remote support with supervision from a neuropsychologist into a digitalized cognitive stimulation program will reinforce the effectiveness of the intervention on cognitive complaints. This will be achieved by improving participation/adherence to the online cognitive stimulation program, as well as through the personalized supervision itself. Investigator believe that the supervision sessions, including educational components, will enable patients to identify their strengths, promote their cognitive awareness, and develop individualized strategies to apply their compensatory abilities in real-life situations. Since cognitive difficulties have multiple underlying causes, reducing these symptoms requires a multifaceted approach. The hypothesis is that combining cognitive training (which increases neuroplasticity and directly targets the cognitive domains affected by cancer and its treatments), with structured supervised educational sessions based on compensatory strategies, will yield better outcomes than online cognitive stimulation alone.

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
UNICANCER

location_facility: Groupe Hospitalier Mutualiste de Grenoble


title: Prognostic Analyses on a Validation Series of Patients With Waldenström's Disease: Validation of International Prognostic Indexes, Evaluation of Progression-free Survival as a Surrogate Endpoint for Overall Survival

acronym: SérieProWM

summary:
Waldenström's macroglobulinemia (WM) is defined by the association of bone marrow lymphoplasmocytic infiltration and monoclonal immunoglobulin M (IgM). A mutation in the MYD88 gene is found in up to 90% of patients, and a mutation in the CXCR4 gene in approximately one third of patients. Treatment should be initiated in cases of cytopenia, bulky disease or when the physicochemical or immunological properties of IgM explain the occurrence of amyloidosis, cryoglobulin, neurological manifestations, or hyperviscosity syndrome (due to the presence of a large amount of IgM). However, approximately 30% of patients are diagnosed without any symptom and therefore they do not meet the criteria for initiating treatment.

At the time of initiation of the first treatment, the prognosis is usually estimated with the International Prognostic Index (IPSSWM) which is based on five variables: age, platelet count, haemoglobin concentrations, β2-microglobulin and monoclonal component concentration. Serum albumin and lactate dehydrogénase (LDH) levels also retain a prognostic role and these two characteristics have been incorporated in a proposal for a revision of this index.

Improving prognostic assessment at the time of the first treatment initiation and taking into account the prognostic impact of events occurring in the course of evolution, should improve the strength of treatment decision at the time of initial treatment and during the follow-up. It should also help to design clinical trial for fast and effective evaluation of new treatments. Our work should also help to adjust clinical monitoring of asymptomatic patients.

Prospective and retrospective multicenter prognostic study with a descriptive objective, associated with a biological collection appropriately annotated and stored. A retrospective series including 470 patients with symptomatic WM is already available. The follow-up of these patients will be updated and an additional series of 250 symptomatic patients will be prospectively enrolled. 250 asymptomatic patients will be also enrolled.

time_perspective: Other

ReferenceCitation: Royston P, Altman DG. External validation of a Cox prognostic model: principles and methods. BMC Med Res Methodol. 2013 Mar 6;13:33. doi: 10.1186/1471-2288-13-33.

ipd_sharing: Undecided

ipd_sharing_description: Specific or all individual participant data sets would be probably shared with the European ECWM Group. For example, data on use of BTKi ( Bruton tyrosine kinases inhibitors) in this population

lead_sponsor: French Innovative Leukemia Organisation

location_facility: APHP - Hôpital Pitié Salpêtrière - Hématologie

location_facility: LILLE GHICL - Hôpital Saint Vincent de Paul

location_facility: Toulouse - IUCT Oncopole - Service d'Hématologie

location_facility: POITIERS - Hématologie et Thérapie Cellulaire


title: Circulating Tumor DNA in Patients With Colorectal Cancer Undergoing Curative-intent Surgery for Liver Metastases: Prospective, Multicenter, GERCOR Cohort

acronym: CLIMES

summary: This is a prospective multicenter cohort study, was designed to explore the prognostic value of ctDNA as a biomarker of disease response and recurrence or death in patients undergoing curative-intent surgical resection of Colorectal cancer liver metastasis.

time_perspective: Prospective

location_facility:
Institut Bergonié
Hôpital Paul Brousse
Centre Léon Bérard
Hôpital Cochin
Hôpital Saint Antoine
CHU de Poitiers
CHRU Tours
Hôpital Bichât Claude Bernard
Institut Gustave Roussy
Institut Mutualiste Montsouris
Hôpital Pitié Salpêtrière
CHU Lille - Hôpital Huriez
Hôpital Haut Lévêque
CHU Rouen
CHU Strasbourg
CHU Jean Minjoz


title: Prognostic and Predictive Markers of Treatment Response in Patients With Pancreatic Adenocarcinoma

acronym: CANOPE

summary: The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy,...) in patients with pancreatic adenocarcinoma. The effectiveness and tolerance of these treatments in current practice is also evaluated.

location_facility: IHU - Institut de chirurgie guidée par l'imagerie


title: Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction

acronym: PARTURP

summary: It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud

location_facility: Hopital Privé de Versailles, Clinique des Franciscaines

location_facility: Centre Hospitalier Universitaire de Bordeaux

appel_a_projets: PHRCN

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: PARTURP

titre: Comparaison des résultats fonctionnels de la résection endoscopique partielle de la prostate à visée de préservation des éjaculation avec la résection endoscopique complète.

discipline_principale: urologie

nom_porteur: Robert

prenom_porteur: Grégoire


title: Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses

acronym: ABSCESSBIOT

summary:
Aseptic abscess syndrome (AA) is a rare entity characterized by the occurrence of deep abscesses with no germ found. Antibiotic therapy is ineffective and they are sensitive to anti-inflammatory treatment with corticosteroids.

Gut microbiota is important for the development of the immune system. In Crohn's disease which is frequently associated with AA syndrome, dysbiosis is found but could also be involved in the immune response at a distance from the gut.

Stool, blood, saliva and urine samples will be taken from the patients included and their controls in the centers where they are followed. These biological samples will be transported to Clermont Ferrand using the same procedure (transporter and dry ice) where the following analyses will be performed: microbiota on stool and saliva, short chain fatty acids on stool and lymphocyte study on blood.

primary_purpose: Diagnostic

location_facility: CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP)

location_facility: Hôpital Louis Mourier - Assistance Publique -Hôpitaux de Paris (AP-HP)

location_facility: Assistance Publique - Hôpitaux de Marseille (AP-HM)

location_facility: Centre Hospitalier Intercommunal Nord-Ardennes

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP)

location_facility: Hôpital La Pitié-Salpétrière - Assistance Publique -Hôpitaux de Paris (AP-HP)

location_facility: Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP)


title: Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis. A Randomized Controlled Trial With an Independent Efficacy Assessor.

acronym: SEQUENS-RA

summary:
In rheumatoid arthritis (RA), the consensual 1st line conventional synthetic disease modifying antirheumatic drugs (csDMARD) of RA is methotrexate (MTX). In case of contra-indication or intolerance to MTX, leflunomide is an alternative. If the treatment target is not achieved with csDMARD strategy, addition of a biological DMARD (TNF inhibitors, anti-Interleukin 6 (anti-IL6)), abatacept, or rituximab) or a targeted synthetic (ts) DMARD (JAK inhibitors) is considered.

Current practice is to start a bDMARD (biologic Disease Modifying Antirheumatic Drugs) and especially TNF inhibitors (etanercept or monoclonal anti-TNF antibodies) with the benefit of hindsight. However, abatacept and TNF inhibitors have demonstrated similar efficacy in patients with insufficient response to csDMARD (AMPLE trial).

Although abatacept has shown a very good tolerance profile that might be superior to other bDMARDs rheumatologists might be reluctant to use it as a first line bDMARD as there is a belief of a slower efficacy compared to other bDMARDs or JAK inhibitors. Indeed, in real world study, compared to TNF inhibitors it seems that discontinuation of abatacept is more related to lack of effectiveness than safety issues.

Investigators have hypothesized that first rapidly controlling the inflammation phase, using TNF inhibitors followed by abatacept to induce an immunological remission would optimize response and tolerance of ACPA positive patients with RA. To demonstrate our hypothesis, the investigaors propose a randomized controlled trial with one arm receiving an induction therapy for 12 weeks with a TNF inhibitor followed by a cell-targeted bDMARD (abatacept) and the other arm, receiving TNF inhibitors.

lead_sponsor: University Hospital, Montpellier

location_country: Monaco France

location_facility: Centre Hospitalier Universitaire de Montpellier


title: BRAINI2-Paediatric : Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury: a European, Prospective, Multicentre Clinical Study

summary:
Mild traumatic brain injury (TBI), defined by a Glasgow Coma Scale (GCS) score of 13 to 15, is the cause of many consultations in paediatric emergency departments (1), even though it is a rare cause of acute complication: approximately 10% of children present with intracranial lesions (ICL) on the CT scan and less than 1% require neurosurgical intervention (2). Although ICLs remain a serious complication requiring rapid diagnosis, brain CT scans, the gold standard diagnostic test, cannot be performed routinely because many children would be unnecessarily exposed to ionising radiation associated with an increased risk of cancer (3). In recent years, several clinical decision rules for the management of mTBI have therefore been developed with the aim of identifying children at high or very low risk of ICL in order to better target CT scan indications. Despite this, the rate of CT scans performed has remained high, up to 35%, and has not decreased with the application of these clinical decision rules (4).

Furthermore, even though the majority of children and adolescents recover quickly after mTBI, nearly 30% will present symptoms such as headaches, dizziness, asthenia, memory, concentration or sleep disorders persisting beyond one month with a possible impact on their quality of life (5). Thus, there is a need to develop new strategies to (i) limit the use of CT scans while minimising the risk of late diagnosis of ICL, (ii) identify children with a higher risk of adverse outcome and/or post-concussive symptoms.

One of the most promising strategies is the use of brain-based blood biomarkers. This study therefore aims to provide new knowledge on two of them, GFAP and UCH-L1 (6,7), in particular by using an automated test combining them (the VIDAS® TBI test developed by bioMérieux) in order to improve the management of CT in the paediatric population at the diagnostic and prognostic levels.

lead_sponsor: Nantes University Hospital

location_country: Germany Spain Switzerland France

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Hospital Universitari Vall d'Hebron (ICS)

location_facility: Klinikum rechts der Isar, Technical University of Munich


title: Randomised Study to Assess the Feasibility and Outcomes of Robotic Assisted Partial Nephrectomy in Low Pressure With AirSeal

acronym: P-NeLoP

summary: The main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR.

status: Active, not recruiting

primary_purpose: Prevention

intervention_type: Device


title: Phase 1-2 Trial Evaluating Metronomic Chemotherapy in Patients With a Relapsed or Refractory Wilms Tumor

acronym: MetroWilms

summary: This is a multicenter, interventional, non-randomized study among patients with a relapsed or refractory Wilms tumor. The study will aim to assess efficacy of metronomic chemotherapy, in terms of disease control after two cycles of metronomic chemotherapy.

lead_sponsor: Centre Oscar Lambret

location_facility: CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT

location_facility: CHRU Strasbourg - Hôpital de Hautepierre

location_facility: CHU de MONTPELLIER - Hôpital Arnaud de Villeneuve

location_facility: Hôpital pour Enfants " La Timone " AP-HM

appel_a_projets: PHRCK

region: Hauts-de-France

nom_etablissement: CLCC OSCAR LAMBRET LILLE

type_etablissement: CLCC

acronyme: MétroWILMS

titre: Etude de phase II évaluant la chimiothérapie métronomique chez des patients avec une tumeur WILMS en rechute ou réfractaire.

discipline_principale: cancer

nom_porteur: SUDOUR-BONNANGE

prenom_porteur: Hélène


title: Targeted Therapies in Chronic Lymphocytic Leukemia and Medico-economic Evaluation of the Ambulatory Medical Assistance Nurse Program : a Prospective Multicenter Randomized Study

acronym: THEMIS

summary: The emergence of targeted therapy (ibrutinib, venetoclax, acalabrutinib) has revolutionized the management practices of chronic lymphoid leukemia due to their effectiveness. However, targeted therapy induces a significant additional cost compared to treatment with immunochemotherapy and their use can be problematic due to the frequent occurrence of side effects, which can be serious. In order to improve the current management of patients treated with targeted therapy, the aim of this study is to evaluate the ambulatory medical assistance nurse program. Ambulatory medical assistance is based on regular telephone calls to patient's homes by a specialist nurse and consists of the monitoring, detection and early management of possible adverse effects of targeted therapy, in link with the hematologist. The main objective of this clinical research is to determine efficiency of the ambulatory medical assistance nurse program.

lead_sponsor: University Hospital, Toulouse

location_facility:
Hôpital Saint-Louis
CH Sud Réunion
Centre Léon Bérard
CHRU de Nancy
CHU de RENNES
CHRU Dijon
Centre Hospitalier Lyon sud
CHU de Reims- Hôpital R.Debré
Hôpital Estaing
CH du Mans
Institut de Cancérologie du Gard
CHU d'Angers
CHU DE BREST Hôpital A.Morvan
Hôpital Emile MULLER
CH Bretagne Atlantique Vannes
Hôpital Bretonneau

appel_a_projets: PRME

region: Occitanie

nom_etablissement: CHU TOULOUSE

acronyme: THEMIS

titre: THérapies ciblées dans la leucémie lymphoïde chronique et Evaluation Médico-économique d'un programme Infirmier de Suivi (THEMIS) : une étude prospective randomisée multicentrique

discipline_principale: hématologie / vigilance et thérapeutique transfusionnelles

nom_porteur: YSEBAERT

prenom_porteur: Loïc


title: A Randomized, Placebo-controlled Phase 3 Trial of Azathioprine for the Prevention of Relapse in Myelin-oligodendrocyte-glycoprotein (MOG)-Antibody Associated Disease

acronym: MOGwAI

summary:
MOG-IgG associated disease (MOGAD) is a rare inflammatory disease of the central nervous system recently described. Initially reported as monophasic, data from incident cohorts suggests that around 50% of adult patients with MOG-Ab may relapse within the first two years of the disease, with most of relapses occurring early after disease onset.

No randomized controlled trial has ever been performed and therapeutic guidelines for this disease remain unclear especially after a single event. In short-sized and mainly retrospective study, azathioprine, an immunosuppressant drug, have showed promising results on preventing the risk of relapse in MOGAD patients.

The hypothesis is that the initiation of a treatment after a first attack of MOGAD should prevent further relapse and disability accrual. The investigators propose herein the first randomized controlled trial in MOGAD, to evaluate the efficacy of azathioprine to prevent relapses, after a first attack, in a placebo double-blinded design.

location_facility: Department of Neurology APHP, Pitié Salpêtrière Hospital

location_facility: Department of Neurology, Hôpital Caremeau

location_facility: Department of Neurology Montpellier Universitary Hospital

location_facility: Department of Neurology, Hôpital g. Et r. Laennec

location_facility: Department of Neurology. Hôpital A. Fondation Rothschild

location_facility: Department of Neurology, CHU de Bordeaux - GH Pellegrin

location_facility: Department of Neurology University hospital Timone

location_facility: Department of Neurology, Hôpital Hautepierre

location_facility: Service de Neurologie sclérose en plaques, pathologies de la myéline et neuro-inflammation - Centre de référence des maladies inflammatoires rares du cerveau et de la moelle (MIRCEM) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon

location_facility: Department of Neurology, Hôpital Pasteur 2

location_facility: Department of Neuro Ophthalmology, CHU of Lyon, Neurology Hospital Pierre Wertheimer

location_facility: Department of Neurology, Toulouse Universitary Hospital

location_facility: Department of Neurology, CHU of Lille, Hospital Roger Salengro


title: High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's Esophagus: Impact on the Detection of High-grade Dysplasia and Adenocarcinoma Lesions

acronym: CONVERSE

summary: The investigators hypothesize that careful examination of Barrett's esophagus by high-resolution endoscopy combined with virtual chromoendoscopy could replace the Seattle protocol for Barrett's esophagus monitoring and detection of dysplasic lesions, and thus modify existing recommendations.

location_facility: Public Assistance - Paris hospitals - Cochin hospital

location_facility: Public Assistance- Paris Hospitals - Georges Pompidou European Hospital


title: LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB IN FRENCH PATIENTS WITH PROGRESSIVE MS: CONSONANCE EXTENSION STUDY

acronym: CONSONANCE EX

summary:
The study duration of 4 years was considered to be sufficient to show a reliable and relevant effect of ocrelizumab on disability progression in the main study (CONSONANCE). However, given the potential long-term use of ocrelizumab in patients with progressive MS, it is critical that additional effectiveness and safety data are accrued in this patient population. In particular, understanding how ocrelizumab can prevent or delay time to major disability milestones such as the need to use an assisting device (Expanded Disability Status Scale [EDSS] 6.0) or a wheelchair (EDSS ≥7.0) is of significant relevance, given that progression to such milestones is associated with a significant reduction in patients' quality of life and an increase in cost of treatment (Kobelt et al. 2017).

In the ORATORIO trial, ocrelizumab reduced the risk of 24-week confirmed EDSS ≥7.0 by 46% (hazard ratio [HR]: 0.54, 95% CI 0.31-0.92; p = 0.022) in patients with primary progressive multiple sclerosis (PPMS). To further characterize the potential long-term impact of ocrelizumab treatment on time to 24-week confirmed EDSS ≥7.0, an analysis was used to extrapolate the observed data into the future, estimating the time at which 50% of patients were expected to have reached EDSS ≥7.0. Extrapolated median time to confirmed EDSS ≥7.0 was 12.1 years for placebo, which was similar to the actual median time observed in MSBase (12.4 years), and 19.2 years for ocrelizumab, representing a 7.1-year delay (95% CI: -4.3 to 18.4) [Butzkueven et al 2021]. A recent MSBase analysis also showed that in a cohort of patients with secondary progressive MS (SPMS), 17.9% reached a confirmed EDSS score of 7.0 from the diagnosis of SPMS, over a period of approximately 12 years (Lizak et al. 2020). Therefore, following patients who complete CONSONANCE beyond the 4-year study period is justified, to better assess the impact of ocrelizumab on these long-term disability milestones.

Another important therapeutic clinical goal in patients with progressive MS is preserving upper limb function. Patients with progressive MS with high EDSS scores, including those who are wheelchair-restricted, experience a devastating reduction in quality of life if they lose any residual function in their arms and/or hands, as this affects the level of independence and significantly limits the ability to perform activities of daily living (Kraft et al. 2014). The Nine-Hole Peg Test (9-HPT) has become one of the most frequently used measures of upper extremity function in MS (Earhart et al. 2011). A 20% worsening in test time is commonly used to define clinically meaningful worsening, as it corresponds to predefined clinically significant changes of established clinician- and patient-reported measures (Feys et al. 2017). Progression rates are lower for 9-HPT compared to EDSS or the Timed 25-Foot Walk Test (25FWT; Goldman et al. 2019). Therefore, following patients who complete CONSONANCE beyond the 4 year study period is justified, to better assess the long-term impact of ocrelizumab on preserving upper limb function.

Patients with MS who have completed the CONSONANCE study, and have a favorable benefit risk ratio, as determined by the treating neurologist, can be included in this study if they meet the inclusion and exclusion criteria.

1.1. Study design

This is a 4-year, single-arm, open-label, multicenter study for patients who have completed 192 weeks of treatment with ocrelizumab in the CONSONANCE study (NCT03523858), and enrolled under the protocol version 1 of CONSONANCE. It is estimated that the study will enroll approximately 90 patients with progressive MS. The study will consist of the following periods:

Screening period: The screening visit should be scheduled up to two weeks before the first infusion of ocrelizumab, and always after the last visit of CONSONANCE at Week 192. This period should not be exceeded.
Treatment period: The first visit of the treatment period (first infusion of ocrelizumab) will occur at the baseline visit, which should be 24 weeks (+14 days) after the last infusion of ocrelizumab in CONSONANCE. Ocrelizumab will be administered every 24 weeks up to Week 168 of this study. The last visit in the treatment period will be conducted 24 weeks after the last dose of ocrelizumab (i.e., at Week 192).

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Montpellier University Hospital
Nancy University Hospital
Lyon University Hospital
Nimes University Hospital
Lille University Hospital
Rennes University Hospital
Clermont ferrand University Hospital
Amiens University Hospital
Caen University Hospital
Strasbourg University Hospital
Bayonne Hospital
Bordeaux University Hospital
Nice University Hospital
Marseille Univesity Hospital
Nantes University hospital


title: Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.

summary:
Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of "oligometastatic" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible.

Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature.

HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation.

Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment.

To investigators knowledge, SRS and HSRT have not been prospectively compared.

collaborators: Association de Neuro-Oncologues d'Expression Francaise

location_facility: Centre d'Oncologie et Radiothérapie Saint-Jean

region: Normandie

nom_etablissement: CRLCC FRANCOIS BACLESSE - CAEN

titre: Radiothérapie stéréotaxique dans la maladie oligo-métastatique cérébrale : Etude de phase 3 randomisée, comparant la stéréotaxie hypofractionnée (3*10 Gy) à la radiochirurgie historique (1*20 à 25 Gy) avec évaluation médico-économique.

nom_porteur: STEFAN

prenom_porteur: Dinu


title: Auvergne-Rhône-Alpes-Limousin Research Database for Still's Diseases in Children and Adults

acronym: AURAL-STILL

summary:
Adult-Onset Still's disease is a polygenic autoinflammatory disease of unknown etiology. The autoinflammatory character individualizes it from autoimmune autoantibody diseases. Clinically, it results in the classic triad associating hectic fever, evanescent rash and arthritis. Although it is benign in the vast majority of cases, life-threatening complications can occur. By definition, the disease affects adults over 16 years of age, however most experts now agree that the adult form and the pediatric form belong to a pathological continuum: Still's disease. In the absence of a specific biomarker, the diagnosis is still based on clinical and biological criteria, after the exclusion of differential diagnoses.

Classically, three evolutionary profiles of Adult-Onset Still's disease are individualized, depending on the evolution of symptoms over time:

a monocyclic systemic form (30% of cases) characterized by clear systemic symptoms and in the foreground compared to the articular signs. This form evolves over several weeks to several months (on average 9 months), without exceeding a year. By definition, there is no recurrence;
a polycyclic systemic form (30% of cases) defined by the occurrence of at least two systemic or joint episodes, separated by clinical remission intervals greater than two months, or even several years. The symptoms of relapses are not always the same as the initial symptoms. The number and severity of relapses is unpredictable and varies widely from patient to patient, but symptoms tend to become less severe over time.
a chronic form, with predominant joint involvement (40%), resembling seronegative rheumatoid arthritis. Systemic signs are present during the first outbreaks of the disease. Subsequently, rheumatoid arthritis evolves on its own and one can see joint destruction or conversely ankylosing developments such as the classic bilateral, non-erosive fusing carpitis.

There are reasons to believe that the evolving profile of patients has changed since the emergence and generalization of biotherapies. Furthermore, no prognostic factor for the progression of Adult-Onset Still's disease has been found so far. The differences between pediatric and adult forms need to be confirmed and becoming pediatric forms in adulthood is poorly described.

The objective of this study is to set up a regional research database (Auvergne-Rhône-Alpes-Limousin) in order to describe the characteristics, treatment and evolution of patients with Still's disease.

ipd_sharing_description: The individual participant data will not be shared

location_facility: Hospices Civils de Lyon - Edouard Herriot


title: Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP Root Canal Sealer: a Prospective, Comparative Randomized Clinical Trial

acronym: EndoPOP

summary:
The study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). The aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer Endomethasone N RCS, compared to the hydrocortisone-free root canal sealer Endomethasone SP RCS, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment.

Root canal treatment procedures will be in accordance with the allocation by randomisation of Endomethasone N RCS or Endomethasone SP RCS. The spontaneous and the Masticatory pain will be record at predefined times, a phone call will be done at 48h and a visit will be realized at day 7 (max Day 14).

lead_sponsor: Septodont

sponsor_collaborators:
Septodont
Slb Pharma

location_facility:
Cabinet Dentaire
Centre dentaire Flandre
Cabinet dentaire
Centre de santé dentaire Chevaleret


title: Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use

acronym: PERSON-AL

summary:
The present project propose to study the effectiveness of a personalized care management of psycho-behavioral symptoms based on an evidence-based standardized assessment to identify and understand the underlying causes of psycho-behavioral symptoms followed by a personalized intervention based on targeted and prioritized actions. This personalized intervention is proposed both to Alzheimer disease (AD) patients living at home with agitation-type psycho-behavioral symptoms, and also to their caregivers with the support and coordination of a nurse working in collaboration with the specialist physician and the General Practitioner (GP). News technologies are used to enhance the follow-up, based on telehealth, and caregiver training.

The project hypothesize that, for a vulnerable population at risk (AD patient with agitation and their caregivers) living at home, a personalized intervention, carried out and coordinated by a nurse in close collaboration with the specialist and GP, would reduce hospitalizations and have a positive effect on the disease evolution and caregiver distress. Also this personalized intervention could reduce the cost of care, in particular by reducing the costs associated with hospitalizations and informal help.

primary_purpose: Supportive Care

location_facility: University Hospital Toulouse - Neurology department

location_facility: Toulouse University Hospital (CHU de Toulouse)

intervention_type: Behavioral

appel_a_projets: PREPS

acronyme: PERSON-AL

titre: PERSONnalisation de la prise en charge des symptômes neuropsychiatriques dans la maladie d'ALzheimer et maladies apparentées: impact sur la trajectoire de soins

discipline_principale: organisation des soins

nom_porteur: Soto

prenom_porteur: Maria


title: Creation of a Register of Patients With Neonatal-onset Epileptic Encephalopathy

acronym: IMPROVE

summary:
Electrical activity emerges in the third trimester of pregnancy, plays an important role in the construction of cortical maps, and is impaired in patients with severe early epileptic encephalopathies (EOEE). EOEE are rare and severe epileptic syndromes characterized by epilepsy that begins within the first three months of life and is associated with rapid deterioration of motor, cognitive and behavioral skills.

There is a genetic basis for the EOEE. Together with other laboratories, the investigators have identified de novo pathogenic variants in the KCNQ2 gene encoding the Kv7.2 subunit of the Kv7 / M potassium channel, a channel known to control neuronal excitability in the brain and spinal cord. via the current M (IM). Pathogenic variants of the KCNQ2 gene represent the main cause of EOEE and the term KCNQ2-related epileptic encephalopathy (KCNQ2-REE) is now used to define this condition.

KCNQ2-REE patients have a remarkably homogeneous phenotype at the start, with epilepsy that begins in the first days after birth, seizures that result in tonic muscle spasms that last from 1 to 10 seconds, and an interictal EEG called "suppression-burst". "That is, paroxysmal bursts of activity interspersed with periods of electrical silence. In this group, more than 50% of the patients present a remission of the epilepsy and a quasi-normalization of the EEG which can occur a few weeks to several months after the onset of the seizures. Despite this positive evolution in terms of seizures, the developmental progression is abnormal and the phenotype is severe with an absence of language, autistic behavior and a subsequent development of motor disorders such as diplegia, spasticity, ataxia or dystonia.

The ambition of this project is to increase knowledge of epileptic encephalopathies linked to KCNQ2 at the clinical and molecular levels, to decipher the pathophysiological mechanisms and to propose therapeutic strategies.

This project aims to better describe the clinical, EEG, imaging, developmental and long-term follow-up characteristics of patients carrying the KCNQ2 mutation identified in the laboratory.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
Hospices Civils Lyon
APHP Pitié Salpêtrière
CHU Montpellier
CHU Toulouse
CHU Tours
CHU Rennes
CHRU Lille
CHRU Strasbourg
CHU Bordeaux
CHU Brest
CHU Limoges
Hôpital La Timone
APHP Robert Debré
CHU Angers
Hôpital Necker


title: Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma: a Randomized Controlled Trial

acronym: LapCHC

summary:
Hepatocellular carcinoma treated by laparotomy or laparoscopic Multicenter prospective, open, superiority, controlled, randomized, clinical trial The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.

Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil

location_facility: Chirurgie digestive - Institut Mutualiste Montsouris

location_facility: Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse

location_facility: Chirurgie Digestive et Transplantations - Hôpital Huriez

location_facility: Chirurgie viscérale et digestive - CHU Besançon

location_facility: Chirurgie hépato-biliaire et greffe de foie - La Pitié

location_facility: Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours

location_facility: Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor

location_facility: Chirurgie viscérale et digestive - CHU Rouen

location_facility: Chirurgie Digestive et de l'Urgence - CHU Grenoble

location_facility: Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: LapCHC

titre: Lap CHC, Intérêt de l'approche laparoscopique dans la prise en charge chirurgicale du carcinome hépatocellulaire : un essai contrôlé randomisé

nom_porteur: SOUBRANE

prenom_porteur: Olivier


acronym: STHENOS

lead_sponsor: Novartis Pharmaceuticals

summary: This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients

title: Open-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMS

type: EudraCT Number

source: euctr

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Italy
United Kingdom
Spain
France

ipd_sharing: Yes


title: Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)

acronym: Hemo-FAST

summary: The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility.

lead_sponsor: Swedish Orphan Biovitrum

sponsor_collaborators:
Swedish Orphan Biovitrum
Kantar Health
Cerner Enviza (former Kantar Health)

intervention_type: Diagnostic Test


title: A Phase II Trial Evaluating Glofitamab, a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy

summary:
This study is a multicenter phase II trial including 2 cohorts of patients in Refractory/Relapse disease at least 1 month after CAR T-cells therapy:

cohort 1: DLBCL patients
cohort 2: PMBL, mantle cell lymphoma, transformed indolent NHL (t-iNHL) or iNHL CAR T-cells Refractory/Relapse status will be determined by PET-CT central review allowing inclusion in this trial.

Patients enrolled will then receive a pre-phase of obinutuzumab followed by experimental treatment:11 cycle of glofitamab.

The primary objective of the study is to assess the anti-lymphoma activity of glofitamab, a bispecific CD3xCD20 monoclonal antibody in patients with relapse/refractory DLBCL (cohort 1) disease after anti-CD19 CAR T-cells therapy

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
IUCT Oncopole
CHU de Brabois
CHU de Rennes - Hôpital Pontchaillou
CHU Nantes
CHU Lyon Sud
CHU Montpellier
Hôpital Saint Louis
APHP - Hôpital de la Pitiè Salpetrière
CHU de Bordeaux - Hôpital Haut Leveque
CHU de Dijon - Hôpital le Bocage
APHP - Hôpital Saint Antoine
Hopital Henri Mondor
CHRU Lille - Hôpital Claude Huriez
Centre Henri Becquerel
CHU de Clermont Ferrand


title: A Randomized, Placebo-controlled, Double-blinded, Phase II Study of Efficacy of Regorafenib as Maintenance Treatment in Patients With High Grade Bone Sarcomas at Diagnosis or Relapse and Without Complete Remission After Standard Treatment

acronym: REGOMAIN

summary:
This is a randomized, double-blinded, 2 arms study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or first relapse.

In the first arm, patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion, whereas in the second arm, patients will be treated with placebo + BSC (standard of care).

The comparison between this two arms will allow to determine whether or not regorafenib and BSC is efficient for disease control, in terms of Progression-Free Survival improvement.

lead_sponsor: Centre Leon Berard

location_facility:
CHRU Hôpital Hautepierre
Chu Saint-Etienne
Centre Georges Francois Leclerc
Ico Rene Gauducheau
Institut Bergonie
ICANS
Iuct Oncopole
Hotel Dieu Nantes
Centre Leon Berard
Hôpital COCHIN
Icm Val D'Aurelle
Institut Gustave Roussy
Centre Oscar Lambret
Chu Besancon
Hopital de La Timone
Institut Curie

region: Auvergne-Rhône-Alpes

nom_etablissement: CENTRE LEON BERARD

acronyme: REGOMAIN

titre: Etude comparative de phase II randomisée, en double aveugle, multicentrique de l'efficacité du regorafenib versus placebo, en association avec les meilleurs soins de support, en traitement de maintenance chez des patients porteurs de sarcomes de haut grade présentant un résidu tumoral après les traitements standards.

nom_porteur: BRAHMI

prenom_porteur: Mehdi


acronym: GYNET

lead_sponsor: NETRIS Pharma

summary: The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with pembrolizumab and/or chemotherapies in patients with advanced/metastatic gynecological cancers (2 types: endometrial carcinoma and cervix carcinoma).

sponsor_collaborators:
NETRIS Pharma
Merck Sharp & Dohme LLC
Centre Leon Berard

location_facility:
Institut Bergonié
Institut Curie (Site Saint Cloud)
Centre Léon Bérard
ICM - Val d'Aurelle
Primary Completion Date
Centre Georges François Leclerc
Aphp Cochin
Hopital de la Croix Saint Simon
CHRU BESANCON - Hopital Jean Minjoz
Institut Gustave Roussy
Centre Eugène Marquis
Centre François Baclesse
Insitut de cancérologie de l'ouest
Institut claudius Regaud

title: A Randomized, Multicenter, Open Label, Phase I/II Study to Evaluate the Safety, Clinical and Biological Activity of a Humanized Monoclonal Antibody Targeting Netrin-1 (NP137) in Combination With Carboplatin Plus Paclitaxel and/or Pembrolizumab in Patients With Locally Advanced/Metastatic Endometrial Carcinoma or Cervix Carcinoma Progressing/Relapsing After at Least One Prior Systemic Chemotherapy.

type: Other Grant/Funding Number


title: Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC).

acronym: AVATAX

summary: The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice, with subgroup analyses of the following patients: patients who have previously received immunotherapy, patients with an EGFR or ALK oncogenic addiction pathway, patients who have previously received taxanes or anti-angiogenic agents.

lead_sponsor: Centre Hospitalier Annecy Genevois

sponsor_collaborators:
Centre Hospitalier Annecy Genevois
University Hospital, Grenoble

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Centre Hospitalier de Versailles André Mignot

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Double-blind, Randomized, Multi-center, Non-inferiority Clinical Trial Comparing Two Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children

summary:
Chemotherapy-induced oropharyngeal mucositis (OM) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia.

Photobiomodulation (PBM) by low level laser therapy (LLLT), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been recommended since 2014 in patients treated with high-dose chemotherapy for bone marrow transplantation. Available pediatric studies highlighted positive/promising results of PBM with excellent safety and no adverse effects. Nevertheless, a wide variety of application parameters is described in the literature, with no consensus guidelines.

Considering the lack of standardized protocol of photobiomodulation in the pediatric population as well as the burden and cost of a daily application, investigators have decided to conduct, for the first time in children of 3 years of age or older, a multicenter, randomized, double-blind, non-inferiority clinical trial to compare two PBM protocols with same PBM parameters, combining red and infrared wavelengths, but with different frequencies of laser application (daily versus every other day), in the treatment of chemotherapy-induced OM of WHO grade 2 or higher.

location_facility:
University hospital of Poitiers
University hospital of Reims
University hospital of Toulouse
University hospital of Angers
University hospital of Rouen
University hospital of Grenoble
University Hospital of Tours
University hospital of Limoges
University hospital of Besançon
University Hospital of Nice
Hôpital La Timone
University hospital of Strasbourg
Armand Trousseau Hospital
University hospital of Saint-Etienne
University hospital of Lille
University hospital of Nancy

titre: Essai clinique de non infériorité, randomisé, multicentrique, en double aveugle, comparant deux modalités d'administration du laser basse.

nom_porteur: PASQUET

prenom_porteur: Marlène


title: Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients During the COVID-19 Pandemic ?

acronym: FERTICOVID

summary: During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Agence de La Biomédecine

location_facility: Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye

location_facility: AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS

location_facility: CHU de Strasbourg - Service de Biologie de la reproduction

location_facility: AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction

location_facility: CHU de Clermont-Ferrand - Laboratoire de Virologie

location_facility: Hospices Civils de Lyon - Service AMP-CECOS

location_facility: Hôpital de la Conception - AP-Hôpitaux de Marseille - Service AMP-CECOS

location_facility: CHU de Nancy - Laboratoire de biologie de la reproduction - CECOS

location_facility: CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS

location_facility: CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS

location_facility: CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims

location_facility: CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS

location_facility: AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction

location_facility: AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS


title: Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study

acronym: RESEDAE

summary: This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes

location_facility: Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes


title: CPX-351 in Higher Risk Myelodysplastic Syndromes: a Phase I/ II Study as First Line or After Hypomethylating-agents Failure

summary: Study of the efficacy of CPX-351 treatment in patients with higher risk myelodysplastic syndromes : as first line treatment or after hypomethylating agents failure

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: CHU d'Angers - Service des maladies du sang

location_facility: IUCT-oncopole - Fédération Hématologie - Médecine Interne

location_facility: CHU de Bordeaux - Hôpital de Haut-Lévêque - Service des maladies du sang

location_facility: CHRU de Limoges - Hôpital Dupuytren - Service d'hématologie clinique et thérapie cellulaire

location_facility: CHU d'Amiens - Service d'hématologie clinique et thérapie cellulaire

location_facility: CHU de Grenoble - Clinique universitaire d'hématologie

location_facility: Hôpital Saint Louis - Service Hématologie Séniors

location_facility: Hôpital Pontchaillou - Service d'hématologie clinique

location_facility: Institut de Cancérologie Lucien Neuwirth - Hématologie Clinique - Thérapie Cellulaire

location_facility: CHU Hôtel Dieu - Service d'Hématologie Clinique

location_facility: CHU de Poitiers - Service d'onco-hématologie et thérapie cellulaire

location_facility: Institut Paoli Calmettes - Unité d'hématologie 3

location_facility: CHU-Hôpital Archet I - Service d'Hématologie Clinique

location_facility: CHU de Besançon - Hôpital Jean Minjoz - Service d'hématologie clinique

location_facility: Centre hospitalier Victor Dupouy - Service d'Hématologie


lead_sponsor: UNICANCER

summary: This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed prostate cancer patients.

sponsor_collaborators:
UNICANCER
Janssen Pharmaceutica

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

title: An Open Label, Randomized, Phase III Study, Evaluating the Efficacy of a Combination of Apalutamide With Radiotherapy and LHRH Agonist in High-risk Postprostatectomy Biochemically Relapsed Prostate Cancer Patients


title: Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia

acronym: MVO

summary:
Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In addition, these toxicities have a negative impact on the patient's quality of life, serious long-term sequelae and are potentially fatal in children.

The risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Angers

location_facility:
Univesity Hostipal of Amiens
University Hospital of Dijon
University Hospital of Rennes
University Hospital of Nantes
University Hospital of La Réunion
University Hospital of Bordeaux
Gustave Roussy
University Hospital of Tours
University Hospital of Nice
Hôpital Trousseau
Hôpital La Timone
University Hospital of Poitiers
University of Brest
Centre Oscar Lambret
University Hospital of Limoges
Institut Curie


title: Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA)

acronym: SINNO-RA

summary:
Rheumatoid arthritis (RA) is one of the main chronic inflammatory rheumatic diseases (RCI), with a prevalence of about 0.4% of the population.

First-line treatment with immunomodulators (synthetic and biological Disease Modifying Anti-Rheumatic Drugs (sDMARDs) including methotrexate) is not sufficiently effective in 40% of cases. These patients are then treated with biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) called biotherapies. As the use of these bio-drugs increases each year, they become a major public health and economic issue. Their growth is only just beginning, as they are among the major providers of pharmaceutical innovation.

There are about ten bio-drugs currently on the market for rheumatoid arthritis with an average annual treatment cost of 8 to 12 000 euros per patient. This cost is 20 times higher than that of sDMARDs. However, among patients treated with biotherapy, clinical practice shows that approximately one-third (33%) will not respond to the selected bio-drugs.

In the event of non-response, physicians currently have no choice but to rotate empirically between different treatments, as no tools capable of predicting response or non-response to these molecules are currently available. SinnoTest® software, a predictive algorithm for responding to bDMARDs by analyzing proteomic biomarkers, will clarify this choice of prescription for patients with failed RA of a first bDMARD in the anti-TNF family.

status: Withdrawn

ReferenceCitation: Nguyen MVC, Baillet A, Romand X, Trocme C, Courtier A, Marotte H, Thomas T, Soubrier M, Miossec P, Tebib J, Grange L, Toussaint B, Lequerre T, Vittecoq O, Gaudin P. Prealbumin, platelet factor 4 and S100A12 combination at baseline predicts good response to TNF alpha inhibitors in rheumatoid arthritis. Joint Bone Spine. 2019 Mar;86(2):195-201. doi: 10.1016/j.jbspin.2018.05.006. Epub 2018 Jun 6.

ReferenceCitation: Nguyen MVC, Adrait A, Baillet A, Trocme C, Gottenberg JE, Gaudin P. Identification of cartilage oligomeric matrix protein as biomarker predicting abatacept response in rheumatoid arthritis patients with insufficient response to a first anti-TNFalpha treatment. Joint Bone Spine. 2019 May;86(3):401-403. doi: 10.1016/j.jbspin.2018.09.005. Epub 2018 Sep 19. No abstract available.

ReferenceCitation: Baillet A, Trocme C, Romand X, Nguyen CMV, Courtier A, Toussaint B, Gaudin P, Epaulard O. Calprotectin discriminates septic arthritis from pseudogout and rheumatoid arthritis. Rheumatology (Oxford). 2019 Sep 1;58(9):1644-1648. doi: 10.1093/rheumatology/kez098.

ReferenceCitation: Baillet A, Trocme C, Berthier S, Arlotto M, Grange L, Chenau J, Quetant S, Seve M, Berger F, Juvin R, Morel F, Gaudin P. Synovial fluid proteomic fingerprint: S100A8, S100A9 and S100A12 proteins discriminate rheumatoid arthritis from other inflammatory joint diseases. Rheumatology (Oxford). 2010 Apr;49(4):671-82. doi: 10.1093/rheumatology/kep452. Epub 2010 Jan 25.

ReferenceCitation: Trocme C, Marotte H, Baillet A, Pallot-Prades B, Garin J, Grange L, Miossec P, Tebib J, Berger F, Nissen MJ, Juvin R, Morel F, Gaudin P. Apolipoprotein A-I and platelet factor 4 are biomarkers for infliximab response in rheumatoid arthritis. Ann Rheum Dis. 2009 Aug;68(8):1328-33. doi: 10.1136/ard.2008.093153. Epub 2008 Jul 29.

lead_sponsor: University Hospital, Grenoble

location_facility: APHP Groupe hospitalier Pitié-Salpêtrière

location_facility: Groupe Hospitalier Pellegrin - CHU de Bordeaux


title: SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR: OPTIMIZATION OF THE PROCEDURE BY REPOSITIONING THE ELECTRODES AND RESEARCH OF THE PREDICTIVE FACTORS OF FAILURE

acronym: SIS

summary: S-ICD (subcutaneous implantable cardioverter-defibrillator) screening failure occurs in about 10% of cases. Predictors of screening failure are not yet well determined. Moreover, slight variations in electrode positioning may change vector configuration and therefore improve screening success rates

lead_sponsor: Centre Hospitalier de PAU

location_facility:
APHP - Pitié Salpêtrière
CHU de Rennes
CHU de Nancy
CHU de Caen
CHU deToulouse
CHRU de Strasbourg
CHRU de BREST
CHU de Limoges
Hopitl Cardiologique Louis Pradel
CHRU de Lille
CHU de Tours
Clinique Pasteur
Hopital Saint Philivert
AP-HP Hôpital européen Georges-Pompidou
CHU de Nantes
CH de Pau


title: A Randomized, Placebo-controlled, Double-blinded, Multicentre Study Evaluating the Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas

acronym: REGOSTA

summary:
This is a randomized, double-blinded, 2 arms study concerning patients with bone sarcoma after the first line therapy.

In the first arm, patients will be treated with regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be treated with placebo (standard of care).

The comparison between this two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of Relapse-Free Survival improvement.

location_facility: Centre Hospitalier Régional de Strasbourg Hautepierre

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Centre Hospitalier Universitaire de Saint-Etienne (CHUSE)

location_facility: Centre Hospitalier Universitaire de Poitiers