title: A Phase II Randomized Multicentre Study Evaluating the Efficacy of Pazopanib+Best Supportive Care (BSC) Versus BSC Alone in Metastatic and/or Locally Advanced Unresectable GIST, Resistant to Imatinib and Sunitinib

acronym: PAZOGIST

summary: The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST) resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.

ReferenceCitation: Blay JY, Bonvalot S, Casali P, Choi H, Debiec-Richter M, Dei Tos AP, Emile JF, Gronchi A, Hogendoorn PC, Joensuu H, Le Cesne A, McClure J, Maurel J, Nupponen N, Ray-Coquard I, Reichardt P, Sciot R, Stroobants S, van Glabbeke M, van Oosterom A, Demetri GD; GIST consensus meeting panelists. Consensus meeting for the management of gastrointestinal stromal tumors. Report of the GIST Consensus Conference of 20-21 March 2004, under the auspices of ESMO. Ann Oncol. 2005 Apr;16(4):566-78. doi: 10.1093/annonc/mdi127. Erratum In: Ann Oncol. 2005 Jun;16(6):993. Mac Clure, J [corrected to McClure, J].

ReferenceCitation: Casali PG, Jost L, Reichardt P, Schlemmer M, Blay JY; ESMO Guidelines Working Group. Gastrointestinal stromal tumors: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2008 May;19 Suppl 2:ii35-8. doi: 10.1093/annonc/mdn080. No abstract available.

ReferenceCitation: Demetri GD, Benjamin RS, Blanke CD, Blay JY, Casali P, Choi H, Corless CL, Debiec-Rychter M, DeMatteo RP, Ettinger DS, Fisher GA, Fletcher CD, Gronchi A, Hohenberger P, Hughes M, Joensuu H, Judson I, Le Cesne A, Maki RG, Morse M, Pappo AS, Pisters PW, Raut CP, Reichardt P, Tyler DS, Van den Abbeele AD, von Mehren M, Wayne JD, Zalcberg J; NCCN Task Force. NCCN Task Force report: management of patients with gastrointestinal stromal tumor (GIST)--update of the NCCN clinical practice guidelines. J Natl Compr Canc Netw. 2007 Jul;5 Suppl 2:S1-29; quiz S30. Erratum In: J Natl Compr Canc Netw. 2007 Aug;5(7):xxx.

ReferenceCitation: Reichardt P, Blay JY, Mehren Mv. Towards global consensus in the treatment of gastrointestinal stromal tumor. Expert Rev Anticancer Ther. 2010 Feb;10(2):221-32. doi: 10.1586/era.09.171.

ReferenceCitation: Montemurro M, Schoffski P, Reichardt P, Gelderblom H, Schutte J, Hartmann JT, von Moos R, Seddon B, Joensuu H, Wendtner CM, Weber E, Grunwald V, Roth A, Leyvraz S. Nilotinib in the treatment of advanced gastrointestinal stromal tumours resistant to both imatinib and sunitinib. Eur J Cancer. 2009 Sep;45(13):2293-7. doi: 10.1016/j.ejca.2009.04.030. Epub 2009 May 19.

ReferenceCitation: Sleijfer S, Ray-Coquard I, Papai Z, Le Cesne A, Scurr M, Schoffski P, Collin F, Pandite L, Marreaud S, De Brauwer A, van Glabbeke M, Verweij J, Blay JY. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol. 2009 Jul 1;27(19):3126-32. doi: 10.1200/JCO.2008.21.3223. Epub 2009 May 18.

ReferenceCitation: Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982 Apr-Jun;1(2):121-9. doi: 10.1002/sim.4780010204.

ReferenceCitation: Corless CL, Fletcher JA, Heinrich MC. Biology of gastrointestinal stromal tumors. J Clin Oncol. 2004 Sep 15;22(18):3813-25. doi: 10.1200/JCO.2004.05.140.

ReferenceCitation: Mazur MT, Clark HB. Gastric stromal tumors. Reappraisal of histogenesis. Am J Surg Pathol. 1983 Sep;7(6):507-19. doi: 10.1097/00000478-198309000-00001.

ReferenceCitation: Schaldenbrand JD, Appelman HD. Solitary solid stromal gastrointestinal tumors in von Recklinghausen's disease with minimal smooth muscle differentiation. Hum Pathol. 1984 Mar;15(3):229-32. doi: 10.1016/s0046-8177(84)80184-7.

ReferenceCitation: Nilsson B, Bumming P, Meis-Kindblom JM, Oden A, Dortok A, Gustavsson B, Sablinska K, Kindblom LG. Gastrointestinal stromal tumors: the incidence, prevalence, clinical course, and prognostication in the preimatinib mesylate era--a population-based study in western Sweden. Cancer. 2005 Feb 15;103(4):821-9. doi: 10.1002/cncr.20862.

ReferenceCitation: DeMatteo RP, Lewis JJ, Leung D, Mudan SS, Woodruff JM, Brennan MF. Two hundred gastrointestinal stromal tumors: recurrence patterns and prognostic factors for survival. Ann Surg. 2000 Jan;231(1):51-8. doi: 10.1097/00000658-200001000-00008.

ReferenceCitation: Emile JF. [GIST: definition, physiopathology]. J Chir (Paris). 2008;145 Suppl 3:6S1-3. French.

ReferenceCitation: Hirota S, Ohashi A, Nishida T, Isozaki K, Kinoshita K, Shinomura Y, Kitamura Y. Gain-of-function mutations of platelet-derived growth factor receptor alpha gene in gastrointestinal stromal tumors. Gastroenterology. 2003 Sep;125(3):660-7. doi: 10.1016/s0016-5085(03)01046-1.

ReferenceCitation: Rubin BP, Singer S, Tsao C, Duensing A, Lux ML, Ruiz R, Hibbard MK, Chen CJ, Xiao S, Tuveson DA, Demetri GD, Fletcher CD, Fletcher JA. KIT activation is a ubiquitous feature of gastrointestinal stromal tumors. Cancer Res. 2001 Nov 15;61(22):8118-21.

ReferenceCitation: Heinrich MC, Corless CL, Duensing A, McGreevey L, Chen CJ, Joseph N, Singer S, Griffith DJ, Haley A, Town A, Demetri GD, Fletcher CD, Fletcher JA. PDGFRA activating mutations in gastrointestinal stromal tumors. Science. 2003 Jan 31;299(5607):708-10. doi: 10.1126/science.1079666. Epub 2003 Jan 9.

ReferenceCitation: Fletcher CD, Berman JJ, Corless C, Gorstein F, Lasota J, Longley BJ, Miettinen M, O'Leary TJ, Remotti H, Rubin BP, Shmookler B, Sobin LH, Weiss SW. Diagnosis of gastrointestinal stromal tumors: A consensus approach. Hum Pathol. 2002 May;33(5):459-65. doi: 10.1053/hupa.2002.123545.

ReferenceCitation: Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007 Mar 20;25(9):1107-13. doi: 10.1200/JCO.2006.09.0183.

ReferenceCitation: Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, Issels R, van Oosterom A, Hogendoorn PC, Van Glabbeke M, Bertulli R, Judson I. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004 Sep 25-Oct 1;364(9440):1127-34. doi: 10.1016/S0140-6736(04)17098-0.

ReferenceCitation: Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, Raymond AK, Bramwell VH, Baker LH, Maki RG, Tanaka M, Hecht JR, Heinrich MC, Fletcher CD, Crowley JJ, Borden EC. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008 Feb 1;26(4):626-32. doi: 10.1200/JCO.2007.13.4452.

ReferenceCitation: Blanke CD, Demetri GD, von Mehren M, Heinrich MC, Eisenberg B, Fletcher JA, Corless CL, Fletcher CD, Roberts PJ, Heinz D, Wehre E, Nikolova Z, Joensuu H. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008 Feb 1;26(4):620-5. doi: 10.1200/JCO.2007.13.4403.

ReferenceCitation: Heinrich MC, Maki RG, Corless CL, Antonescu CR, Harlow A, Griffith D, Town A, McKinley A, Ou WB, Fletcher JA, Fletcher CD, Huang X, Cohen DP, Baum CM, Demetri GD. Primary and secondary kinase genotypes correlate with the biological and clinical activity of sunitinib in imatinib-resistant gastrointestinal stromal tumor. J Clin Oncol. 2008 Nov 20;26(33):5352-9. doi: 10.1200/JCO.2007.15.7461. Epub 2008 Oct 27.

ReferenceCitation: Kumar R, Knick VB, Rudolph SK, Johnson JH, Crosby RM, Crouthamel MC, Hopper TM, Miller CG, Harrington LE, Onori JA, Mullin RJ, Gilmer TM, Truesdale AT, Epperly AH, Boloor A, Stafford JA, Luttrell DK, Cheung M. Pharmacokinetic-pharmacodynamic correlation from mouse to human with pazopanib, a multikinase angiogenesis inhibitor with potent antitumor and antiangiogenic activity. Mol Cancer Ther. 2007 Jul;6(7):2012-21. doi: 10.1158/1535-7163.MCT-07-0193.

ReferenceCitation: Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarba JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.

ReferenceCitation: Hutson TE, Davis ID, Machiels JP, De Souza PL, Rottey S, Hong BF, Epstein RJ, Baker KL, McCann L, Crofts T, Pandite L, Figlin RA. Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2010 Jan 20;28(3):475-80. doi: 10.1200/JCO.2008.21.6994. Epub 2009 Dec 14.

ReferenceCitation: Mir O, Cropet C, Toulmonde M, Cesne AL, Molimard M, Bompas E, Cassier P, Ray-Coquard I, Rios M, Adenis A, Italiano A, Bouche O, Chauzit E, Duffaud F, Bertucci F, Isambert N, Gautier J, Blay JY, Perol D; PAZOGIST study group of the French Sarcoma Groupe-Groupe d'Etude des Tumeurs Osseuses (GSF-GETO). Pazopanib plus best supportive care versus best supportive care alone in advanced gastrointestinal stromal tumours resistant to imatinib and sunitinib (PAZOGIST): a randomised, multicentre, open-label phase 2 trial. Lancet Oncol. 2016 May;17(5):632-41. doi: 10.1016/S1470-2045(16)00075-9. Epub 2016 Apr 5.

sponsor_collaborators:
Centre Leon Berard
GlaxoSmithKline

location_facility:
Institut Bergonié
Centre Léon Bérard
Institut Paoli Calmette
Hôpital Tenon
CHU de Reims
Institut Cancerologie Neuwirth
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Institut Gustave Roussy
Hôpital de la Timone
Centre Georges François Leclerc
Hôpital St Antoine
Centre Alexis Vautrin


title: A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort in Subjects With Male Stress Urinary Incontinence

summary: The purpose of this study is to monitor the use of Virtue® Male Sling in a real world population and collect medical data on effectiveness and to monitor safety of Virtue® at 12 and 36 months post device implantation in men with post-prostatectomy urinary incontinence.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

ipd_sharing_description: There is not a plan to make IPD available

lead_sponsor: Coloplast A/S

location_country: Italy France

location_facility: Centre Hospitalier Chalon Sur Saône William Morey

location_facility: Clinique Mutualiste de la Porte de l'Orient

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Identification of the Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor of HR+ Metastatic Breast Cancer in Post-menopausal Women

acronym: SAFIR-TOR

summary: This is a prospective biomarker study to show that p4EBP1 staining predicts clinical benefit from treatment with everolimus in patients who are eligible for everolimus+exemestane treatment. This trial is not aimed at evaluating a drug activity. Everolimus and exemestane are prescribed within their approved indication as per usual practice and are not part of this trial.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Screening

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: UNICANCER

collaborators:
Novartis
Fondation ARC

sponsor_collaborators:
UNICANCER
Novartis
Fondation ARC

location_facility: Institut de Cancérologie de l'Ouest/Rene Gauducheau

location_facility: Institut de Cancérologie de l'Ouest/Paul Papin

location_facility: INSTITUT DE CANCEROLOGIE Lucien Neuwirth

location_facility: Institut de Cancerologie de Lorraine Alexis Vautrin

intervention_type: Procedure

status_simplified: Completed


title: A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With Oral Potentially Malignant Lesions (OPML) or Head and Neck Squamous Cell Carcinoma (HNSCC) (IHNPACT UMBRELLA)

acronym: UMBRELLA

summary:
This is a multicenter minimal risk or burden prospective 3-cohort follow-up and monitoring study that aims to collect clinical, socio-psychological, medico-economics data and biospecimens for patients with oral potentially malignant lesions (OPML) or resectable head and neck squamous cell carcinoma (HNSCC) :

Cohort A: OPML patients.
Cohort B (specific design): smokers (adults who have smoked at least 100 cigarettes in their lifetime) motivated to quit - either current smokers (who currently smokes cigarettes every day (daily) or some days (nondaily)) or former smokers (adults who have smoked at least 100 cigarettes in their lifetime, but say they currently do not smoke) who stops smoking within 3 months prior to the diagnosis - with a resectable HNSCC requiring postoperative radiotherapy or chemoradiation.
Cohort C: Patients with resectable HNSCC non-eligible to cohort B.

The primary objective of this study is the identification of biomarkers (predictive of malignant transformation or second primary tumor) and new strategies for prevention and therapy, mainly through extensive genomic, epigenomic and immune characterization of OPML and HNSCC.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Dundee - Discovery Research Portal

version: publishedVersion

repository_institution: Newcastle Univesity - Newcastle University ePrints

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: Centre Leon Berard

location_facility: CHU de Montpellier, Hôpital Gui De Chauliac

location_facility: Hospices Civils de Lyon, Hôpital Lyon Sud

lead_sponsor_type: academique

status_simplified: Unknown


title: Trenza Embolization Device for Intrasaccular Aneurysm Treatment

summary: The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.

lead_sponsor: Stryker Neurovascular

location_country:
Finland
Italy
Germany
United Kingdom
Austria
Spain
France

location_facility: Hospital Universitario Central De Asturias (HUCA)

location_facility: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Klinikum rechts der Isar der Technischen Universität München


type: Other Identifier

title: Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Low or Intermediate-1 Myelodysplastic Syndrome: A Prospective Multicenter Phase II Study Based on Donor Availability on Behalf of the GFM & SFGM-TC

summary: Comparison of survival in patients with or without a matched donor at 36 months

status: Active, not recruiting

primary_purpose: Treatment

ReferenceCitation: Robin M, Fenaux P. Which lower risk myelodysplastic syndromes should be treated with allogeneic hematopoietic stem cell transplantation? Leukemia. 2020 Oct;34(10):2552-2560. doi: 10.1038/s41375-020-0967-x. Epub 2020 Jul 13.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

lead_sponsor: Groupe Francophone des Myelodysplasies

collaborators:
Novartis
Neovii Biotech

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Novartis
Neovii Biotech

location_facility: Institut de cancérologie Lucien Neuwirth

intervention_type: Other


title: Gemcitabine-oxaliplatin Plus Rituximab (R-GEMOX) in Refractory/Relapsed Patients With CD 20 Positive Diffuse Large B-cell Lymphoma, Non Eligible for High-dose Chemotherapy Followed by Autotransplantation

summary: The Purpose of this study is to evaluate the efficacy and the safety of R-GEMOX in refractory/relapsed patients with CD20-positive large B-cell lymphoma who are not eligible for autologous transplantation.

ReferenceType: background

ReferenceCitation: Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.

ReferenceCitation: Chau I, Webb A, Cunningham D, Hill M, Rao S, Ageli S, Norman A, Gill K, Howard A, Catovsky D. An oxaliplatin-based chemotherapy in patients with relapsed or refractory intermediate and high-grade non-Hodgkin's lymphoma. Br J Haematol. 2001 Dec;115(4):786-92. doi: 10.1046/j.1365-2141.2001.03181.x.

ReferenceCitation: Machover D, Delmas-Marsalet B, Misra SC, Gumus Y, Goldschmidt E, Schilf A, Frenoy N, Emile JF, Debuire B, Guettier C, Farrokhi P, Boulefdaoui B, Norol F, Parquet N, Ulusakarya A, Jasmin C. Dexamethasone, high-dose cytarabine, and oxaliplatin (DHAOx) as salvage treatment for patients with initially refractory or relapsed non-Hodgkin's lymphoma. Ann Oncol. 2001 Oct;12(10):1439-43. doi: 10.1023/a:1012501305214.

ReferenceCitation: Faivre S, Raymond E, Woynarowski JM, Cvitkovic E. Supraadditive effect of 2',2'-difluorodeoxycytidine (gemcitabine) in combination with oxaliplatin in human cancer cell lines. Cancer Chemother Pharmacol. 1999;44(2):117-23. doi: 10.1007/s002800050955.

ReferenceCitation: Savage DG, Rule SA, Tighe M, Garrett TJ, Oster MW, Lee RT, Ruiz J, Heitjan D, Keohan ML, Flamm M, Johnson SA. Gemcitabine for relapsed or resistant lymphoma. Ann Oncol. 2000 May;11(5):595-7. doi: 10.1023/a:1008307528519.

ReferenceCitation: Mounier N, El Gnaoui T, Tilly H, Canioni D, Sebban C, Casasnovas RO, Delarue R, Sonet A, Beaussart P, Petrella T, Castaigne S, Bologna S, Salles G, Rahmouni A, Gaulard P, Haioun C. Rituximab plus gemcitabine and oxaliplatin in patients with refractory/relapsed diffuse large B-cell lymphoma who are not candidates for high-dose therapy. A phase II Lymphoma Study Association trial. Haematologica. 2013 Nov;98(11):1726-31. doi: 10.3324/haematol.2013.090597. Epub 2013 Jun 10.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Lymphoma Study Association

sponsor_collaborators:
Lymphoma Study Association
Hoffmann-La Roche
Sanofi-Synthelabo
Eli Lilly and Company

location_facility: Service d'Hématologie Clinique - CHU Le Bocage

location_facility: Service D'Hématologie Adulte - Hôpital Necker

location_facility: Service des Maladies du Sang - CHRU de Lille

intervention_type: Drug


title: A French Multicentric Observational Study of Acalabrutinib in the Treatment of Chronic Lymphocytic Leukemia Patients

acronym: NAOS

summary:
The efficacy and safety of acalabrutinib in the treatment of patients with chronic lymphocytic leukemia (CLL) have been well established through 3 phase III clinical trials (ELEVATE TN, ASCEND, ELEVATE R/R) that led to European Medicines Agency approval in November 2020. The aim of this French longitudinal, non-interventional/observational, multicenter study is to describe the efficacy and safety of acalabrutinib treatment for CLL patients in real life.

The primary objective is then to estimate the time to discontinuation of acalabrutinib therapy and the reasons for discontinuation, overall and by treatment line.

The secondary objectives are to describe the baseline clinical and demographic characteristics of patients with CLL treated with acalabrutinib, to assess the efficacy of acalabrutinib through progression-free survival, overall survival, time to next treatment or death, describe acalabrutinib treatment patterns in CLL patients and reasons, identify key determinants of acalabrutinib discontinuation in CLL patients, estimate healthcare resource utilization. The overall response rate will be estimated as an exploratory objective.

Patients included in this study will be CLL patients treated with acalabrutinib at the discretion of their physician between January 1, 2021 and December 31, 2022, who have been informed of the study and do not object to electronic processing of their data for research purposes (or do not object during their lifetime in the event of the patient's death prior to study initiation).

Secondary data will be extracted from the hospital's patient records once a year. The protocol calls for the recruitment of 350 patients at 70 centres with a 3-year follow-up. Interim analyses will be performed annually until the end of the study.

time_perspective: Retrospective

lead_sponsor: AstraZeneca


title: Phase I Study of Fluvastatin-Celebrex Association for Optico-chiasmatic Low Grade Gliomas and High Grade Gliomas Localized Outside the Brainstem, Relapsed or Refactory, in Children or Young Adults

acronym: FLUVABREX

summary:
Optico-chiasmatic gliomas have therapeutic feature since surgical resection plays a secondary role. Unlike other sites, many of these tumors are not amenable to complete resection either because of anatomical location, and sometimes they only can be biopsied. A substantial number of children will have recurrences following resection or will experience progression following incomplete tumor removal or biopsy.

Celebrex is a Cox-2 inhibitor with anti-angiogenic and anti-tumor properties, while statins are known to increase the sensitivity of gliomas to anti-tumor agents. Their association could be administered for long periods, in the hope of much reduced risk of toxicities.

This is a national, multicentric, interventional, open-label, non-comparative, and non-randomized phase I study evaluating the maximum tolerated dose of the Fluvastatin in combination with fixed-dose of Celebrex.

This project involves 10 SFCE health centers accustomed to phase I / II studies(Société Française de Lutte contre les Cancers et Leucémies de l'Enfant et de l'Adolescent - French Society for the Fight against Cancer and Leukemia in Children and Adolescents).

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
Anticancer Fund, Belgium

location_facility: Centre Hospitalier de Purpan - Hôpital des Enfants


type: EudraCT Number

title: Phase III Randomized Clinical Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer Considering Two Different Settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)

acronym: CHIPPI

summary: This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC combined with standard care (PDS or IDS) or standard care alone.

design_allocation: Randomized

location_country: Belgium France

location_facility: Cliniques universitaires St-Luc, Institut Roi Albert II


title: Thoracic Aortic Stent-graft Study for the Treatment of Thoracic Aortic Pathologies - Assessment of the Relay Plus and Relay NBS Plus Stent-graft

summary: Stent treatment of thoracic aortic pathologies, including aneurysms, pseudo-aneurysms, dissections, intramural hematomas, penetrating ulcers and ruptures of the isthmus, seems to provide a likely benefit compared to surgery in terms of surgical mortality and severe morbidity. However, the data concerning the long-term fate of these stents are insufficient. For this reason, the French National Health Authority (HAS) requests a 5-year follow-up in relation to the renewal of insurance reimbursement for these stent-grafts. Therefore, this long-term observational study has been set up.

lead_sponsor: Vascutek Ltd.

sponsor_collaborators:
Vascutek Ltd.
Federation of Medical Specialties

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel - HCL

location_facility: Hôpitaux Universitaires de Strasbourg - NHC


title: Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus

summary: Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: Claudio N, Dalet A, Gatti E, Pierre P. Mapping the crossroads of immune activation and cellular stress response pathways. EMBO J. 2013 May 2;32(9):1214-24. doi: 10.1038/emboj.2013.80. Epub 2013 Apr 12.

ReferenceCitation: Clavarino G, Claudio N, Couderc T, Dalet A, Judith D, Camosseto V, Schmidt EK, Wenger T, Lecuit M, Gatti E, Pierre P. Induction of GADD34 is necessary for dsRNA-dependent interferon-beta production and participates in the control of Chikungunya virus infection. PLoS Pathog. 2012;8(5):e1002708. doi: 10.1371/journal.ppat.1002708. Epub 2012 May 17.

ReferenceCitation: Clavarino G, Claudio N, Dalet A, Terawaki S, Couderc T, Chasson L, Ceppi M, Schmidt EK, Wenger T, Lecuit M, Gatti E, Pierre P. Protein phosphatase 1 subunit Ppp1r15a/GADD34 regulates cytokine production in polyinosinic:polycytidylic acid-stimulated dendritic cells. Proc Natl Acad Sci U S A. 2012 Feb 21;109(8):3006-11. doi: 10.1073/pnas.1104491109. Epub 2012 Feb 6.

ReferenceCitation: Costedoat-Chalumeau N, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin du LT, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Tanguy ML, Hulot JS, Lechat P, Musset L, Amoura Z, Piette JC; Group PLUS. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study). Ann Rheum Dis. 2013 Nov;72(11):1786-92. doi: 10.1136/annrheumdis-2012-202322. Epub 2012 Nov 10.

ReferenceCitation: Niewold TB, Clark DN, Salloum R, Poole BD. Interferon alpha in systemic lupus erythematosus. J Biomed Biotechnol. 2010;2010:948364. doi: 10.1155/2010/948364. Epub 2010 Jun 29.

ReferenceCitation: Novoa I, Zeng H, Harding HP, Ron D. Feedback inhibition of the unfolded protein response by GADD34-mediated dephosphorylation of eIF2alpha. J Cell Biol. 2001 May 28;153(5):1011-22. doi: 10.1083/jcb.153.5.1011.

ReferenceCitation: Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.

ReferenceCitation: Ronnelid J, Tejde A, Mathsson L, Nilsson-Ekdahl K, Nilsson B. Immune complexes from SLE sera induce IL10 production from normal peripheral blood mononuclear cells by an FcgammaRII dependent mechanism: implications for a possible vicious cycle maintaining B cell hyperactivity in SLE. Ann Rheum Dis. 2003 Jan;62(1):37-42. doi: 10.1136/ard.62.1.37.

ReferenceCitation: Wang S, Kaufman RJ. The impact of the unfolded protein response on human disease. J Cell Biol. 2012 Jun 25;197(7):857-67. doi: 10.1083/jcb.201110131.

ReferenceCitation: Yap DY, Lai KN. The role of cytokines in the pathogenesis of systemic lupus erythematosus - from bench to bedside. Nephrology (Carlton). 2013 Apr;18(4):243-55. doi: 10.1111/nep.12047.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

ipd_sharing: Yes

ipd_sharing_description: No data will be be shared with non associated investigator till publication. Possibility to share after publication, through formol requirement adressed to Grenoble hospital administration (AccueilRecherche@chu-grenoble.fr)

lead_sponsor: University Hospital, Grenoble

location_facility: groupement hospitalier mutualiste de Grenoble

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

type_etablissement: CH

titre: Évaluation pronostique de l'augmentation de l'expression du gène codant pour GADD34 au cours du lupus érythémateux systémique (LES)

discipline_principale: autre

nom_porteur: CESBRON

prenom_porteur: Jean-Yves


title: Clinical Evaluation of Kaname Cobalt-Chromium Coronary Stent System in the Treatment of Patients With Coronary Artery Disease

acronym: KARE

summary: The purpose of this study is to assess whether the new Kaname coronary stent is safe and effective for the treatment of patients with coronary artery disease.

lead_sponsor: Terumo Europe N.V.

location_country: Germany Italy Spain Serbia France

location_facility: Hopital d'Instructions des Armées du Val de Grace

location_facility: Klinikum des Johannes Gutenberg Universität

location_facility: Institute for Cardiovascular Disease Dedinje

location_facility: Hopital Cardiovasculaire et Pneumologie Louis Pradel


title: Multicentre, Randomised, Controlled, Open-label Study Comparing the Efficacy and Safety of Doxorubicin Transdrug™ to Best Standard of Care in Patients With Advanced Hepatocellular Carcinoma. ReLive Study.

acronym: ReLive

summary:
The purpose of this phase III study is to determine whether Doxorubicin Transdrug (DT) is effective in the treatment of patients suffering from advanced Hepatocellular Carcinoma (HCC) after failure or intolerance to Sorafenib. Patients with HCC with or without cirrhosis and with good liver functions are eligible. Only those who can not benefit from treatment for which efficacy is demonstrated are eligible.

These patients are usually proposed either best standard of care (BSC) or participation to clinical trials. Patients eligible for the RELIVE study will receive either DT at 20 mg/m2 or DT at 30 mg/m2 or the BSC.

ReferenceCitation: Merle P, Blanc JF, Phelip JM, Pelletier G, Bronowicki JP, Touchefeu Y, Pageaux G, Gerolami R, Habersetzer F, Nguyen-Khac E, Casadei-Gardini A, Borbath I, Tran A, Wege H, Saad AS, Colombo M, Abergel A, Richou C, Waked I, Yee NS, Mole A, Attali P, Le Boulicaut J, Vasseur B; RELIVE Investigators. Doxorubicin-loaded nanoparticles for patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE): a phase 3 randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Jun;4(6):454-465. doi: 10.1016/S2468-1253(19)30040-8. Epub 2019 Apr 4. Erratum In: Lancet Gastroenterol Hepatol. 2019 Jul;4(7):e6. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):e1.

publisher_dissemination: Elsevier

lead_sponsor: Valerio Therapeutics

location_country:
Germany
Italy
Hungary
Austria
Belgium
Lebanon
United States
Spain
Turkey
Egypt
France

location_facility: Clinical Research Center/ Alexandria university hospital

location_facility: Semmelweis Egyetem Radiológiai és Onkoterápiás Klinika

location_facility: Medical Oncology department /Mansoura University Hospitals

location_facility: Irccs Centro Di Riferimento Oncologico (Cro)

location_facility: Szegedi Tudományegyetem Onkoterápiás Klinika

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Oncology Department, Medical Research Institute, Alexandria University

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Klinikum rechts der Isar der TU Munchen II

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet

location_facility: Egyesített Szent István és Szent László Kórház - Rendelőintézet

location_facility: IRST Istituto Romagnolo Ricerca e Cura dei Tumori

location_facility: Hospital General Universitario de Alicante

location_facility: National Liver Institute / Menoufyia University

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Medical Oncology department /Ain Shams University Hospitals

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hospital General Universario Gregorio Maranon

location_facility: National hepatology and tropical medicine research institute

location_facility: Ausl 12 Livorno Ospedale Unico della Versilia


title: Anesthésie Totale Intraveineuse en " Boucle d'Asservissement " guidée Par l'Index Bispectral : Effet de l'Adjonction de Protoxyde d'Azote (Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia)

summary: The main objective of the study is to analyze the influence of nitrous oxide on propofol and remifentanil requirements.

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

ReferenceCitation: Karalapillai D, Leslie K, Umranikar A, Bjorksten AR. Nitrous oxide and anesthetic requirement for loss of response to command during propofol anesthesia. Anesth Analg. 2006 Apr;102(4):1088-93. doi: 10.1213/01.ane.0000198672.05639.0a.

ReferenceCitation: Liu N, Le Guen M, Boichut N, Genty A, Herail T, Schmartz D, Khefif G, Landais A, Bussac JJ, Charmeau A, Baars J, Rehberg B, Tricoche S, Chazot T, Sessler DI, Fischler M. Nitrous oxide does not produce a clinically important sparing effect during closed-loop delivered propofol-remifentanil anaesthesia guided by the bispectral index: a randomized multicentre study. Br J Anaesth. 2014 May;112(5):842-51. doi: 10.1093/bja/aet479. Epub 2014 Jan 31.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

lead_sponsor: Hopital Foch

location_country: Germany Belgium France

location_facility: Centre Hospitalier Territorial Gaston Bourret


title: Detection and Characterization of Sessile Serrated Lesions (SSL) of the Right Colon

acronym: Lesion SSL

summary:
There are a few studies regarding Sessile Serrated Lesions (SSL). They are recently identified as precancerous lesions. Yet, digestive tract serrated lesions would be part of a new colic carcinogenesis way : the serrated tumor way. Evolution from polyp to cancer would be faster than through the usual adenoma to cancer way. It would be then responsible of a lot of "missed" lesions or interval cancer. The missed SSL rate is estimated at between 27% and 59%.

Current diagnosis methods show weakness to identify those SSL. In order to improve their detection, the investigators dispose of several coloration techniques. Indigo carmine chromoendoscopy enhance neoplastic lesion detection as part of the hereditary rectal carcinoma screening. NBI electronic coloration, which is faster and easier has not shown any efficacy on the adenoma detection rate, except for patients with Lynch syndrome.

The objective is to better describe the SSL endoscopic semiology (detection and characterization) and to establish standards for the endoscopic techniques in order to improve the colonoscopy diagnosis quality. The investigators propose to evaluate 2 fundamental endoscopic techniques (Narrow Band Imaging (NBI) and indigo carmine), widely used for other indications, in comparison with the White Light technique (WLI).

Therefore, the investigators propose a prospective, observational, multicentric cohort study in order to 1) define SSL endoscopic various aspects 2) establish which technique (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) is the best to diagnose SSL, namely detection and characterization 3) evaluate the multifocal dimension rate for those lesions at ascending colon level.

The diagnosis impact is immediate, and could allow to consider an update for boh endoscopic NICE and Kudo Pit Pattern classification, and good practice guidances for colonoscopic diagnosis. Better SSL detectability thus their systematic resection could have a long term effect in reducing both colon cancer rate and interval cancer

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Estaing, CHU Clermont Ferrand, NHE Service d'Hépato-gastroentérologie, 1 place Lucie Aubrac

location_facility: Hospices Civils de Lyon, Hôpital E Herriot, Service d'hépatogastroentérologie, 5 place d'Arsonval

location_facility: Hospices Civils de Lyon, Hôpital Lyon Sud, Service d'hépato-gastroentérologie, Chemin Grand Revoyet

location_facility: Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'hépato-gastroentérologie, 103 Grande-Rue de la Croix Rousse

location_facility: Centre Hospitalier Villefranche sur Saône, Service d'Hépato-gastroentérologie, Plateux d'Ouilly Gleize

location_facility: Centre Hospitalier Saint JOSEPH Saint Luc, Service d'hépato-gastroentérologie, 20 quai Claude Bernard


title: Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.

summary: The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

status: Unknown status

lead_sponsor: Hopital Antoine Beclere

location_facility:
CH Caremeau
Centre Hospitalier Paul Ardier
Hopital Diaconesses Croix Saint Simon
CHU Pellegrin
CH Chambery
Chu Nancy
CH Rouen
Hôtel Dieu
Hopital Saint Andre
Hopital Antoine Beclere
CH Rennes
Centre Hospitalier Universitaire
CH Dunkerque
CHU Amiens


type: Registry Identifier

title: Phase III Trial Testing the Benefit of Intensity-modulated Radiotherapy With Weekly Replanifications Versus Intensity Modulated Radiotherapy With Only One Planification in Locally Advanced Oropharynx Carcinoma for Decreasing Xerostomia

acronym: ARTIX

summary: The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.

lead_sponsor: Center Eugene Marquis

location_facility:
CHU de la Milétrie
Centre Léon Bérard
Clinique Claude Bernard
Centre Eugene Marquis
CHU Tours
CRLCC Henri Becquerel
Clinique Pasteur - Saint Esprit
Centre Paul Strauss
CRLCC Oscar Lambret
CRLCC Baclesse
CRLCC Antoine Lacassagne

intervention_type: Radiation


title: Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy

summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.

ReferenceCitation: Frenel JS, Kim JW, Aryal N, Asher R, Berton D, Vidal L, Pautier P, Ledermann JA, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Colombo N, Park-Simon TW, Tamura K, Sonke GS, Freimund AE, Lee CK, Pujade-Lauraine E. Efficacy of subsequent chemotherapy for patients with BRCA1/2-mutated recurrent epithelial ovarian cancer progressing on olaparib versus placebo maintenance: post-hoc analyses of the SOLO2/ENGOT Ov-21 trial. Ann Oncol. 2022 Oct;33(10):1021-1028. doi: 10.1016/j.annonc.2022.06.011. Epub 2022 Jun 27.

oa_colors: green hybrid

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

ReferenceCitation: Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

ReferenceCitation: Poveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Friedlander M, Baldoni A, Park-Simon TW, Tamura K, Sonke GS, Lisyanskaya A, Kim JH, Filho EA, Milenkova T, Lowe ES, Rowe P, Vergote I, Pujade-Lauraine E; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):620-631. doi: 10.1016/S1470-2045(21)00073-5. Epub 2021 Mar 18.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

version: submittedVersion

ReferenceCitation: Tjokrowidjaja A, Lee CK, Friedlander M, Gebski V, Gladieff L, Ledermann J, Penson R, Oza A, Korach J, Huzarski T, Manso L, Pisano C, Asher R, Lord SJ, Kim SI, Lee JY, Colombo N, Park-Simon TW, Fujiwara K, Sonke G, Vergote I, Kim JW, Pujade-Lauraine E. Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy. Eur J Cancer. 2020 Nov;139:59-67. doi: 10.1016/j.ejca.2020.08.021. Epub 2020 Sep 23.

ReferenceCitation: Friedlander M, Gebski V, Gibbs E, Davies L, Bloomfield R, Hilpert F, Wenzel LB, Eek D, Rodrigues M, Clamp A, Penson RT, Provencher D, Korach J, Huzarski T, Vidal L, Salutari V, Scott C, Nicoletto MO, Tamura K, Espinoza D, Joly F, Pujade-Lauraine E. Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. Lancet Oncol. 2018 Aug;19(8):1126-1134. doi: 10.1016/S1470-2045(18)30343-7. Epub 2018 Jul 17.

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2. Epub 2017 Jul 25. Erratum In: Lancet Oncol. 2017 Sep;18(9):e510.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Australia
Brazil
Japan
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
Canada
Russian Federation
France

location_facility: Klinikum rechts der Isar der Technischen Universität

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: First affiliated hospital college of XianJiaotong University

location_facility: St.Petersburg City Oncology Dispensary, Dept. Gynecology

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: The First Affiliated Hospital of Soochow University

location_facility: City Hospital Birmingham Cancer Trials Team

location_facility: Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH

location_facility: Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alagre

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Cancer Research UK and UCL Cancer Trials Centre

location_facility: Saitama Medical University International Medical Center

location_facility: The Tumor Hospital affiliated to China Medical Science Insti

location_facility: Istituto Regina Elena-Polo Oncologico Ifo

location_facility: Niigata University Medical and Dental Hospital

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

location_facility: Azienda Ospedaliera Policlinico Di Modena

location_facility: Royal Marsden Hospital and Institute of Cancer Research

location_facility: West China Hospital Affiliated to Sichuan University

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie

location_facility: Chemotherapy Department, Russian Cancer Research Centre

location_facility: Shanghai Cancer Hospital of Fudan University

location_facility: Centrum Onkologii Instytut im Marii Sklodowskiej-Curie

location_facility: Barcelona,H.de la Sta.Creu i S.Pau,Oncología

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Winthrop Gynecologic Oncology Associates

location_facility: The Tumour Hospital of Harbin Medical University

location_facility: Women's Hospital, Zhejaing University School of Medicine


title: A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse

acronym: MAXIMS

summary: To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.

ReferenceCitation: Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3):e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Max-Delbrueck-Center for Molecular Medicine - MDC Repository

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Vermersch P, Benrabah R, Schmidt N, Zephir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O. Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study. BMC Neurol. 2012 Jun 12;12:36. doi: 10.1186/1471-2377-12-36.

ReferenceCitation: Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.

publisher_dissemination: American Chemical Society

lead_sponsor: AB Science

location_country:
Italy
Poland
Sweden
Spain
Greece
Ukraine
Russian Federation
France

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: LLC "Center of socially significant diseases"

location_facility: AHEPA University Hospital, Aristotle University of Thessaloniki

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: State Budgetary Institution of Health of the City of Moscow City Polyclinic #2

location_facility: Centre Hospitalier Universitaire Toulouse

location_facility: Service de Neurologie Hôpital Henri-Mondor

location_facility: Centre hospitalier intercommunal de Poissy-Saint-Germain-en-Laye

location_facility: Le Centre hospitalier universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire Nimes - Service de Neurologie

location_facility: Azienda Ospedaliero Universitaria Policlinico "G.Rodolico -San Marco"

location_facility: Communal Non-Profit Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council, Department of Neurology #1

location_facility: Gregorio Marañón General University Hospital

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Rivne Regional Specialized Dispensary for Radiation Protection of the Population Municipal Enterprise

location_facility: Eginition Hospital, Athens University Medical School


title: Phase 2, Open-Label Study Evaluating Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B-Non Hodgkin Lymphoma (B-NHL) Who Are Ineligible to Autologous Stem Cell Transplantation

summary: This is a phase 2, open-label, multicenter study evaluating axicabtagene ciloleucel (axi-cel) as a 2nd line therapy in patients with Relapsed/Refractory aggressive B-NHL who are ineligible to receive Autologous Stem Cell Transplantation but eligible to receive CAR T-cell therapy.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
IUCT Oncopole
APHP - Hôpital Saint Louis
APHP - Hôpital Henri Mondor
CHU de Rennes - Hôpital de Pontchaillou
Hôpital Saint Antoine
CHU Clermont Ferrand - Hôpital Estaing
CHU Brabois
CHU de Nantes - Hôtel Dieu
CH Liège
CHU de Bordeaux - Hôpital Haut Lévêque
CHU de Dijon - Hôpital le Bocage
Hôpital Saint Eloi
Institut de Cancérologie Gustave Roussy
Hopital La Pitié Salpétriere
Centre Hospitalier Lyon Sud
Hôpital Claude Huriez


title: Feasibility of New Biological and Histological Samples at Progression for Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

acronym: GFPC-REBIOP

summary:
Feasibility of new biological and histological samples at progression in patients with advanced or metastatic Non Small Cell Lung Cancer (NSCLC).

A recent paper from Professor Sequist and coll. has depicted the resistance mechanisms as Thréonine790Methionine (T890M) mutation oncogene cMet (CMet) amplification. Re-biopsies showed in 14% of cases the transition between NSCLC to Small Cells Lung Cancer (SCLC). In 3 patients, resistance mechanisms have disappeared and they became again sensitive to Tyrosine Kinase Inhibitors (TKIs). It is mandatory to have a better description to natural history of the disease. This study will be conducted by the French Group of Pneumology-Oncology (Groupe Français de Pneumo Cancérologie (GFPC)) up to 100 patients during 18 Months. Each center will have to define if re-biopsies are possible or not and explain why not.

primary_purpose: Basic Science

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 20
Site 25
Site 04
Site 06
Centre François Baclesse
Centre Hospitalier du Morvan
Hospital du Cluzeau
Centre Hospitalier Universitaire
Hospital Saint Antoine


title: Optimal Control of Liver Metastases With Intravenous Cetuximab and Hepatic Artery Infusion of Three-drug Chemotherapy in Patients With Liver-only Metastases From Colorectal Cancer. A European Multicenter Phase II Trial

acronym: OPTILIV

summary: The primary objective of the study is to increase by 15% the complete macroscopic resection rate of predominantly liver metastases from metastatic colorectal cancer through combining systemic cetuximab and hepatic artery infusion of three-drug chemotherapy (irinotecan, oxaliplatin and 5-fluorouracil).

ReferenceCitation: Bouchahda M, Boige V, Smith D, Karaboue A, Ducreux M, Hebbar M, Lepere C, Focan C, Guimbaud R, Innominato P, Awad S, Carvalho C, Tumolo S, Truant S, De Baere T, Castaing D, Rougier P, Morere JF, Taieb J, Adam R, Levi F; ARTBC International. Early tumour response as a survival predictor in previously- treated patients receiving triplet hepatic artery infusion and intravenous cetuximab for unresectable liver metastases from wild-type KRAS colorectal cancer. Eur J Cancer. 2016 Nov;68:163-172. doi: 10.1016/j.ejca.2016.09.011. Epub 2016 Oct 18.

repository_institution: University of Warwick - Warwick Research Archive Portal

ReferenceCitation: Levi FA, Boige V, Hebbar M, Smith D, Lepere C, Focan C, Karaboue A, Guimbaud R, Carvalho C, Tumolo S, Innominato P, Ajavon Y, Truant S, Castaing D, De Baere T, Kunstlinger F, Bouchahda M, Afshar M, Rougier P, Adam R, Ducreux M; Association Internationale pour Recherche sur Temps Biologique et Chronotherapie (ARTBC International). Conversion to resection of liver metastases from colorectal cancer with hepatic artery infusion of combined chemotherapy and systemic cetuximab in multicenter trial OPTILIV. Ann Oncol. 2016 Feb;27(2):267-74. doi: 10.1093/annonc/mdv548. Epub 2015 Nov 16.

lead_sponsor: Association pour la Recherche sur le Temps Biologique et la Chronothérapie

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Italy Portugal Belgium France

location_facility: Azienda Ospedaliera S.Maria Degli Angeli

location_facility: Chronotherapy Unit, Medical Oncology Department, Paul Brousse Hospital


title: Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Romidepsin CHOP (Ro-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

summary: Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by a Response Adjudication Committee (RAC).

ReferenceCitation: Bachy E, Camus V, Thieblemont C, Sibon D, Casasnovas RO, Ysebaert L, Damaj G, Guidez S, Pica GM, Kim WS, Lim ST, Andre M, Garcia-Sancho AM, Penarrubia MJ, Staber PB, Trotman J, Huttmann A, Stefoni V, Re A, Gaulard P, Delfau-Larue MH, de Leval L, Meignan M, Li J, Morschhauser F, Delarue R. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). J Clin Oncol. 2022 Jan 20;40(3):242-251. doi: 10.1200/JCO.21.01815. Epub 2021 Nov 29.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

sponsor_collaborators: The Lymphoma Academic Research Organisation

location_country:
Germany
Italy
Portugal
Singapore
Belgium
Korea, Republic of
Spain
France

location_facility: Charité Medical School Campus Virchow-Klinikum

location_facility: UniversitätsKrebszentrum Göttingen - G-CCC

location_facility: Istituto di Ematologia "Saragnoli" Policlinico San'Orsola-Malpighi, Bologna

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Centre Hospitalier de Versailles - André Mignot

location_facility: Universitätsklinikum Carl Gustav Carus der TU Dresden

location_facility: Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo

location_facility: Charité Medical School Campus Benjamin Franklin

location_facility: Hospital Universitario Dr. Peset de Valencia

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Azienda Ospedaliera universitaria Careggi

location_facility: Universitätklinikum Freiburg Klinik für Innere medizin I

location_facility: CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Institut d'Hématologie de Basse-Normandie

location_facility: ICO - Institut Català d'Oncologia - Hospital Doctor Josep Trueta


title: French Biological Observatory on Lung Cancer in Never Smokers

acronym: BioCAST

summary: Lung cancer in non-smokers (LCINS) is an increasing public health problem. The BioCAST (IFCT-1002) study, promoted by Intergroupe Francophone de Cancérologie Thoracique (IFCT), focuses on this entity. It is a national, multicentric, prospective epidemiological study. Main objective is to describe the clinical and molecular epidemiology of LCINS in a large French cohort composed by cases newly diagnosed in participating centres (around to 1000 patients expected). The clinical component of the study is based on collecting data directly from the patient through a standardized questionnaire during a telephone interview with a health professional. The biologic component includes a blood sample collection. A large genomic-wide association study and an epigenetic study are also planned. BioCAST hopes to provide concrete answers to clinicians and patients questions about this new and frequent entity.

ReferenceCitation: Couraud S, Debieuvre D, Moreau L, Dumont P, Margery J, Quoix E, Duvert B, Cellerin L, Baize N, Taviot B, Coudurier M, Cadranel J, Missy P, Morin F, Mornex JF, Zalcman G, Souquet PJ; BioCAST/IFCT-1002 study investigators. No impact of passive smoke on the somatic profile of lung cancers in never-smokers. Eur Respir J. 2015 May;45(5):1415-25. doi: 10.1183/09031936.00097314. Epub 2015 Mar 5.

evidence: open (via free pdf)

publisher_dissemination: European Respiratory Society

ReferenceCitation: Couraud S, Souquet PJ, Paris C, Do P, Doubre H, Pichon E, Dixmier A, Monnet I, Etienne-Mastroianni B, Vincent M, Tredaniel J, Perrichon M, Foucher P, Coudert B, Moro-Sibilot D, Dansin E, Labonne S, Missy P, Morin F, Blanche H, Zalcman G; French Cooperative Intergroup IFCT. BioCAST/IFCT-1002: epidemiological and molecular features of lung cancer in never-smokers. Eur Respir J. 2015 May;45(5):1403-14. doi: 10.1183/09031936.00097214. Epub 2015 Feb 5.

ReferenceCitation: Couraud S, Vaca-Paniagua F, Villar S, Oliver J, Schuster T, Blanche H, Girard N, Tredaniel J, Guilleminault L, Gervais R, Prim N, Vincent M, Margery J, Larive S, Foucher P, Duvert B, Vallee M, Le Calvez-Kelm F, McKay J, Missy P, Morin F, Zalcman G, Olivier M, Souquet PJ; BioCAST/IFCT-1002 investigators. Noninvasive diagnosis of actionable mutations by deep sequencing of circulating free DNA in lung cancer from never-smokers: a proof-of-concept study from BioCAST/IFCT-1002. Clin Cancer Res. 2014 Sep 1;20(17):4613-24. doi: 10.1158/1078-0432.CCR-13-3063. Epub 2014 Jul 10.

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Couraud S, Labonne S, Missy P, Morin F, Tran Q, Deroy A, Milleron B, Blanche H, Zalcman G, Souquet PJ; les membres du Groupe de travail << non-fumeurs de l'IFCT >>. [Lung cancer in never smokers: a French national cohort (BioCAST/IFCT-1002)]. Rev Mal Respir. 2013 Sep;30(7):576-83. doi: 10.1016/j.rmr.2013.03.006. Epub 2013 May 18. French.

ReferenceCitation: Fontaine-Delaruelle C, Mazieres J, Cadranel J, Mastroianni B, Dubos-Arvis C, Dumont P, Monnet I, Pichon E, Locatelli-Sanchez M, Dixmier A, Coudert B, Fraboulet S, Foucher P, Dansin E, Baize N, Vincent M, Missy P, Morin F, Moro-Sibilot D, Couraud S; IFCT10-02 BioCAST investigators. Somatic profile in lung cancers is associated to reproductive factors in never-smokers women: Results from the IFCT-1002 BioCAST study. Respir Med Res. 2020 Mar;77:58-66. doi: 10.1016/j.resmer.2020.01.003. Epub 2020 Jan 31.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_concat: HAL

ReferenceCitation: Paris C, Do P, Mastroianni B, Dixmier A, Dumont P, Pichon E, Chouaid C, Coudert B, Foucher P, Fraboulet S, Locatelli-Sanchez M, Baize N, Dansin E, Moreau L, Vincent M, Missy P, Morin F, Moro-Sibilot D, Couraud S; BioCAST/IFCT-1002 study investigators; to the BioCAST/IFCT- 1002 study. Association between lung cancer somatic mutations and occupational exposure in never-smokers. Eur Respir J. 2017 Oct 26;50(4):1700716. doi: 10.1183/13993003.00716-2017. Print 2017 Oct.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

location_facility: Hôpitaux du Léman - Pneumologie et Maladies Infectieuses


title: Open, Non Controlled, Multicenter, First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Preliminary Antitumor Activity of GM102 in Patients With Advanced Pretreated Gynecological Cancer

summary: First in Human study, assessing the safety profile, the pharmacokinetics and preliminary antitumor activity of GM102, a new compound (a monoclonal antibody), in patients with previously treated gynecological cancers bearing the AMHRII (anti-mullerian Hormone Receptor II) receptor. The primary objective of the study is to determine the GM102 recommended dose.

ReferenceCitation: Prat M, Le Naour A, Coulson K, Lemee F, Leray H, Jacquemin G, Rahabi MC, Lemaitre L, Authier H, Ferron G, Barret JM, Martinez A, Ayyoub M, Delord JP, Gladieff L, Tabah-Fisch I, Prost JF, Couderc B, Coste A. Circulating CD14high CD16low intermediate blood monocytes as a biomarker of ascites immune status and ovarian cancer progression. J Immunother Cancer. 2020 Jun;8(1):e000472. doi: 10.1136/jitc-2019-000472.

publisher_dissemination: British Medical Journal

lead_sponsor: GamaMabs Pharma

location_country:
United Kingdom
Belgium
France

location_facility: Institut Universitaire Cancer Toulouse - Oncopole


title: Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)

acronym: ENDOFERT

summary: The ENDOFERT Study is an open, multicenter, randomized, parallel-group, controlled trial. This study includes patients presenting colorectal DIE and infertility. Patients will be randomized in two parallel-groups; one group underwent complete surgery of colorectal DIE prior to ART and the other group underwent ART alone (ratio 1:1)

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Ministry of Health, France

location_facility:
CHU
Hôpital Jeanne de Flandres, CHRU
AP-HP, Hôpital Tenon

appel_a_projets: PHRCN

region: Hauts-de-France

nom_etablissement: CHR LILLE

acronyme: ENDOFERT

titre: Apport de la chirurgie première dans la prise en charge de l'infertilité des patientes présentant une endométriose colorectale : Chirurgie complète puis FIV versus FIV d'emblée

discipline_principale: gynécologie

nom_porteur: COLLINET

prenom_porteur: Pierre


title: Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study

acronym: PEPsy

summary: Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu Saint Etienne
HÔPITAL Edouard Herriot
Chu Grenoble
Chu Clermont-Ferrand
Chu Le Vinatier


title: Prevalence of HPV Transmission During Medically Assisted Procreation Procedures

acronym: AMPAMAVIR

summary: Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk of oncogenicity especially for the anal and cervical mucosa. At the present time, no recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP) procedures. The main objective of this prospective multicentric cohort study is to evaluate the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP, (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the correlation between HPV and male infertility and (4) the correlation between HPV and success rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV vaccination policy.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de SAINT-ETIENNE
CHU de CLERMONT-FERRAND
Hôpital BICHAT
Hôpital Jean VERDIER
CHU de BORDEAUX


title: Search for Predictive Markers of Efficacy of Epoetin Beta (NEORECORMON) in the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Chemotherapy or Myelodysplastic Syndrome

acronym: EPO

summary: Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
Ministry of Health, France

location_facility:
Bretagne Atlantic Hospital
Saint-Malo Hospital
Rennes University Hospital
Laval Hospital
Yves Le Foll Hospital


title: Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients

acronym: HEMIMARCHE

summary: The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months.Following the initial screening, subjects will be randomized into two groups: one who continues attending two physical therapy sessions per week for two months, or the other one who stops physical therapy sessions for two months. Before and after those two months, a 3 days recording will be made using an ambulatory system called TRIDENT.

primary_purpose: Supportive Care

location_facility: Institut Régional de médecine physique et de Réadaptation

location_facility: Groupe hospitalier Pellegrin CHU Bordeaux

location_facility: Centre Régional de Réeducation et de Réadaptation Fonctionnelle

intervention_type: Behavioral


title: Evaluation of the Water-Enema Computed Tomography for the Diagnosis of Colon Tumor

summary:
The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen.

The goal of the study is the evaluation of its performances for the diagnosis of colon tumors.

lead_sponsor: University Hospital, Angers

sponsor_collaborators:
University Hospital, Angers
Ministry of Health, France

location_facility:
UH of Angers
UH of Rennes
UH of Montpellier
UH of Lyon
UH of Besancon


title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase 3 Study to Compare Efficacy and Safety of Masitinib 6 mg/kg/Day in Combination With Bortezomib and Dexamethasone to Placebo in Combination With Bortezomib and Dexamethasone in the Treatment of Patients With Relapsing Multiple Myeloma Who Received One Previous Therapy

summary: The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in combination with bortezomib and dexamethasone to placebo in combination with bortezomib and dexamethasone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.

location_country:
United States
France

location_facility: Froedtert & Medical College of Wisconsin-CLCC


title: Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms

summary: The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is the subject of this observational study. 180 patients will be implanted with the Anaconda™ Stent Graft System and will be followed-up annually for 5 years post-implant. The study will satisfy the requirements of the French National Authority for Health (Haute Autorité de santé) and the data collected will be used for reimbursement renewal.

lead_sponsor: Vascutek Ltd.

location_facility: Centre Hospitalier Universitaire - Hopital Michallon

location_facility: Centre Hospitalalier Universitaire - Hopital Brabois

location_facility: Centre Hospitalier Universitaire - Hopital Civil


title: Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma

acronym: ART-ORL

summary:
The purpose of this study is to do health economic evaluation of tomotherapy and dynamic arctherapy (2 techniques exist: RapidArc and Vmat).

This study evaluate also local disease control after 18 months in patients with an ENT epidermoid carcinoma and treated by tomotherapy orarctherapy .

The number of patients required in this study is: 300:

Number of patients treated with tomotherapy: 120
Number of patients treated with dynamic arctherapy RapidArc: 120
Number of patients treated with dynamic arctherapy Vmat: 60

This is a prospective; multicentric and non randomized study.

ReferenceCitation: Bibault JE, Dussart S, Pommier P, Morelle M, Huguet M, Boisselier P, Coche-Dequeant B, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Servagi Vernat S, Perrier L, Giraud P. Clinical Outcomes of Several IMRT Techniques for Patients With Head and Neck Cancer: A Propensity Score-Weighted Analysis. Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):929-937. doi: 10.1016/j.ijrobp.2017.06.2456. Epub 2017 Jun 27.

ReferenceCitation: Bibault JE, Morelle M, Perrier L, Pommier P, Boisselier P, Coche-Dequeant B, Gallocher O, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Perol D, Dussart S, Giraud P. Toxicity and efficacy of cetuximab associated with several modalities of IMRT for locally advanced head and neck cancer. Cancer Radiother. 2016 Jul;20(5):357-61. doi: 10.1016/j.canrad.2016.05.009. Epub 2016 Jun 23.

lead_sponsor: Centre Leon Berard

collaborators: The Biostatistics and Therapy Evaluation Unit

location_facility:
Hôpital Eurppéen Geoges POMPIDOU
Centre Léon Bérard
Centre Val d'Aurelle
Centre René GAUDUCHEAU
Centre Paul STRAUSS
Institut Claudius Regaud
Intitut Curie
Groupe Oncorad Garonne
Centre Oscar Lambret
Institut Sainte Catherine
Centre Eugène Marquis
Institut BERGONIE
Centre Alexis Vautrin
Centre Privé de Radiothérapie de Metz


title: Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES STUDY)

acronym: EFIRTES

summary:
The present study was designed to assess the efficacy of infliximab in a 2-period study :

An initial period with comparison of infliximab versus placebo and allowing the determination of the primary criteria
Then an extension period in which the 2 arms will receive infliximab (in the placebo group : 5 perfusions and in the experimental group 3 supplemental perfusions). Finally, the 2 groups will receive 5 injections of infliximab There is little evidence in the literature of when and how infliximab should be administered in sarcoidosis. We hypothesized, from our personal experience in 30 cases (18 of which were reported in a retrospective trial (14), that infliximab would have a very quick activity. So it appeared reasonable to evaluate the primary criterion at 6 weeks after initiation of the treatment.

ipd_sharing_description:
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hopital de la Croix Rousse- service de Médecine Interne

location_facility: Hopital de la Timone- service de Médecine Internne

location_facility: Nouvel Hopital Civil- service de Médecine Interne

location_facility: Hopital Avicenne - service de pnaumologie

location_facility: Hopital Henri Mondor- service de Médecine Interne

location_facility: GH la Pitié Salpêtrière. Service de Médecine interne

location_facility: CHU Hotel Dieu - service de Médecine Interne

location_facility: Hopital Claude Huriez- service de Médecine Interne

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: EFIRTES

titre: Comparaison du cyclophosphamide et de l'infliximab en traitement d'induction des sarcoïdoses extra-thoraciques résistantes

discipline_principale: médecine interne

nom_porteur: COHEN AUBART

prenom_porteur: Fleur


title: Effect of an Early Therapeutic Permutation on the Tumoral Control of Patients Receiving in First Line a Specific Inhibitor of Tyrosin Kinase of EGFR (Erlotinib) or a Taxan-based Chemotherapy for the Treatment of Not Resecable Adenocarcinoma With Bronchiolo-alveolar.

summary: To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control rate after 4 months treatment of an early therapeutic permutation with the first month in the absence of stabilization or objective answer.

ReferenceCitation: Wislez M, Gounant V, Cadranel J. [Bronchioloalveolar carcinoma]. Rev Mal Respir. 2005 Dec;22(6 Pt 2):8S70-5. French.

ReferenceCitation: Wislez M, Massiani MA, Milleron B, Souidi A, Carette MF, Antoine M, Cadranel J. Clinical characteristics of pneumonic-type adenocarcinoma of the lung. Chest. 2003 Jun;123(6):1868-77. doi: 10.1378/chest.123.6.1868.

ReferenceCitation: Cadranel J, Gervais R, Merle P, Moro-Sibilot D, Westeel V, Bigay-Game L, Quoix E, Friard S, Barlesi F, Lethrosne C, Moreau L, Monnet I, Salaun M, Oliviero G, Souquet PJ, Antoine M, Langlais A, Morin F, Wislez M, Zalcman G; Intergroupe Francophone de Cancerologie Thoracique (IFCT). Erlotinib versus carboplatin and paclitaxel in advanced lepidic adenocarcinoma: IFCT-0504. Eur Respir J. 2015 Nov;46(5):1440-50. doi: 10.1183/13993003.02358-2014. Epub 2015 Sep 17.

location_facility: APHP - CHU Avicenne - Oncologie Medicale


title: Pacemaker Remote Electrogram Monitoring Study (PREMS)

acronym: PREMS

summary:
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect anomalies that may deserve a clinical action.

PREMS is a non-interventional, prospective, and multicenter study. The primary objective is to assess the added clinical value of periodic IEGMs, based on the rate of patients with a rhythm or sensing/pacing anomaly detected on the first IEGM transmitted by Home Monitoring (HM) and non detectable so obvious on the other parameter set offered for the remote follow-up.

lead_sponsor: Biotronik SE & Co. KG

location_facility:
Clinique de la Marche
CHG Villefranche
Cabinet Descartes
HIA Saint Anne
Cabinet de Cardiologie
CH Montbrison
CH St Luc St Joseph
Clinique Clairval
CH d'Annecy
CH de Bastia
CH André Mignot
CH de Roanne
Clinique des Dômes
CH de Valence
CHU Hôpital Charles Nicolle
Hôpital Privé Paul d'Egine
Polyclinique du Parc
Cabinet de cardiologie
CH des Broussailles
CH de Chambéry
CH d'Aurillac
Polyclinique Saint Laurent
HPOP
CH de Castres
Polyclinique Nord Aquitaine
CH Paul Morel
Clinique Belledonne
Clinique Axium
CH de Douarnenez
CH de Niort
CH de Blois
CH de Nevers
Clinique de l'Anjou
Clinique Bon Secours
CHG de Longjumeau
Hôpitaux du Léman
CH de Saint Malo
Clinique du Mousseau
Hôpital Sainte Musse CHI
Clinique de Saint Georges de Didonnes
CH Léon Binet
Clinique Saint Vincent
CH d'Antibes
CH Annonay
Polyclinique Sevigné
CH Pierre Oudot
CH Val d'Ariège
CH de Chartres


title: A Comparison of Blood and Tissue Biomarkers Before and After Nephrectomy in the First-line Setting With Everolimus in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

acronym: NEORAD

summary:
Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma

An open-label, exploratory, single-arm, multicenter trial.

Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to nephrectomy.

Two to four weeks after surgery, everolimus will be reintroduced only for metastatic patients until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Hôpital Européen Georges Pompidou - Service d'oncologie médicale

location_facility: Fôpital d'Instruction des Amées du Val de Grâce

location_facility: Institut de Cancérologie Lucien Neuwirth


title: A Double-blind, Randomized, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088, in Healthy Volunteers

summary: This is the first study of single and multiple doses of IFB-088 in human subjects. The current study is designed to assess in the first part, the safety, tolerability, plasma and urine pharmacokinetics (PK) of single oral doses of IFB-088 in healthy subjects (Single Ascending Doses - SAD) and in a second part safety, tolerability, plasma and urine pharmacokinetics (PK) of multiple oral doses of IFB-088 in healthy subjects (Multiple Ascending Doses - MAD)

primary_purpose: Other

lead_sponsor: InFlectis BioScience

collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques (CIC-CPCET)


title: Comparison of Fecal Microbiota Between Patients With Early and Late Crohn's Disease and Relationship With Different Genetic and Serological Profiles

acronym: COMeBACk

summary:
The cause of CD could be different according to age at onset of CD symptoms. Indeed we know that some very young patients at CD diagnosis have particular genetic variants as abnormalities of the IL10R that are regarded as quite monogenic disease. In the other way, the microbiota also undergoes substantial changes at the extremes of life, in infants and older people and the ramifications of which are very few being explored. The comparison of microbiota by principal component analysis and genetic profile of patients with CD beginning at the extremes of life could help us to better known physiopathology of CD according to age and provide arguments that CD beginning at the extremes of life could be different diseases.

The aim of the study is to ascertain through population-based study the hypothesis that gut microbiota is different between paediatric-onset and elderly-onset CD patients in relation with genetic and environmental mechanisms. The results will provide a better knowledge of the etiopathogenic ways in CD and propose a personalized therapeutic care based on age at CD onset (i.e. according to the gut bacteria involved).

sponsor_collaborators:
University Hospital, Lille
National Research Agency, France

location_facility: Lille University Hospital & EPIMAD Registry

intervention_type: Biological


title: Masitinib in Combination With FOLFIRI Versus Masitinib Alone, Versus Best Supportive Care, in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer

summary: A prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer

location_country:
United Kingdom
Spain
Czechia
Russian Federation
France

location_facility: Hammersmith Hospital Imperial College Healthcare Nhs Trust


title: A Double-blind Randomized Non-inferiority Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery: Effects on Acute Postoperative Pain.

acronym: ER-One

summary: The block (ESP or PVB) will be performed preoperatively in the recovery room under standard monitoring. After setting a peripheral venous access, patient will be installed on lateral decubitus position on the opposite side of the block.

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
National Cancer Institute, France

location_facility:
Institut de Cancérologie de Lorraine
Institut Claudius Régaud UICT
AP-HP Hôpital Tenon
Centre Jean Perrin
Institut Curie


title: An Open-labelled, International, Multicenter, Dose Escalating, Phase I/II Study of SPC2996,an LNA Antisense Molecule Against Bcl-2, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia

summary: The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL)

lead_sponsor: Santaris Pharma A/S

location_country:
United States
Denmark
United Kingdom
France

location_facility: MRC Toxicology Unit, University of Leicester

location_facility: Service d'HématologieCentre Hospitalier Lyon-Syd

location_facility: Holden Comprehensive Cancer Center, Univ. of Iowa


title: International Randomized Comparison Between DES Limus Carbostent and Taxus Drug Eluting Stents in the Treatment of De-novo Coronary Lesions. The NEXT Study.

acronym: NEXT

summary: The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.

ReferenceCitation: Carrie D, Berland J, Verheye S, Hauptmann KE, Vrolix M, Violini R, Dibie A, Berti S, Maupas E, Antoniucci D, Schofer J. A multicenter randomized trial comparing amphilimus- with paclitaxel-eluting stents in de novo native coronary artery lesions. J Am Coll Cardiol. 2012 Apr 10;59(15):1371-6. doi: 10.1016/j.jacc.2011.12.009. Epub 2012 Jan 25.

lead_sponsor: CID - Carbostent & Implantable Devices

location_country: Germany Italy Belgium France

location_facility:
Azienda Ospedaliera Careggi
Clinique les Franciscaines
Clinique Saint-Hilaire
Institut Mutualiste Montsouris
Academisch Ziekenhuis Middelheim
Medizinisches Versorgungszentrum
Ospedale S. Camillo
Istituto di Fisiologia Clinica del CNR
Krankenhaus der Barmherzigen Brüder
Hôpital de Rangueil
Ziekenhuis Oost Limburg


title: Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis

summary: NutriPEPA2 is a randomized, single-blind, prospective, multicenter trial, in two parallel arms to confirm that the adsorbent PEPA membrane may decrease mortality related to inflammation and malnutrition encountered in HD or HDF-treated stage 5 renal failure compared to a non-adsorbent synthetic membrane.

lead_sponsor: Theradial

location_country: Monaco France

location_facility:
Ch Annonay
Ch Besancon
CH Saint Brieuc
CH Saint Quentin
CHPM Monaco
Ch Toulouse Larrey
Aura Paris Plaisance
Chru Tours
Ch Chartres
Ch Metz-Thionville
CH MEAUX
Ch La Rochelle


title: Randomized Phase II Trial Evaluating the Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Wild Type KRAS/NRAS Colorectal Cancer

summary:
Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy.

There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended.

The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome.

It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study.

Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

collaborators:
Amgen
Roche Pharma AG

location_country: Netherlands Austria Belgium Switzerland Spain France

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Assistance Publique - Hôpitaux de Paris - Hopital De Bicetre AP-HP

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: CHU de Lyon - Centre Hospitalier Lyon Sud

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: CHU Saint-Etienne - CHU de Saint-Etienne - Hopital Nord

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie


title: Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial

acronym: ACROHNEM

summary: This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of P28GST could protect against recurrence after intestinal resection surgery in CD.

ReferenceCitation: Foligne B, Ple C, Titecat M, Dendooven A, Pagny A, Daniel C, Singer E, Pottier M, Bertin B, Neut C, Deplanque D, Dubuquoy L, Desreumaux P, Capron M, Standaert A. Contribution of the Gut Microbiota in P28GST-Mediated Anti-Inflammatory Effects: Experimental and Clinical Insights. Cells. 2019 Jun 12;8(6):577. doi: 10.3390/cells8060577.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

evidence: oa repository (semantic scholar lookup)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
pdfs.semanticscholar.org

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: MDPI

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Centre hospitalier
Centre Hospitalier,
CHRU, Hôpital Claude Huriez
Centre Hospitalier de Boulogne
Centre Hospitalier Dunkerque


title: Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity : a Multicenter Randomized Trial

acronym: RANSPRE

summary: The purpose of this study is to determine whether first-trimester screening for preeclampsia based on the FMF algorithm (a combination of maternal clinical, sonographic and biochemical parameters), improves maternal or perinatal health.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
INSERM, Epopé team

location_facility: Hôpital de la conception et de la Timone


title: Prognostic Value of Quick Sequential Organ Failure Assessment Kinetics After Fluids Challenge in the Emergency Department

acronym: DELTASCREEN

summary: The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2.

ipd_sharing_description: data will be available upon request to the principal investigator

lead_sponsor: Societe Française de Medecine d'urgence

location_country: Spain Belgium France

location_facility:
Cliniques St Luc
Saint Antoine
Cochin
CHU Nimes
Hopital Pitié-Salpêtrière
Hopital Europeen Georges Pompidou
Hospital Clinic
Hopital Tenon
CHU Strasbourg
Lariboisière


title: Study of the Impact of the Stage of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors (ITK) in Patients Treated for Metastatic Kidney Cancer

acronym: IREKI

summary: The study of the blood concentration of ITK what are pazopanib and cabozantinib at 1 month and 3 months from the start of treatment will allow to evaluate the impact of renal failure on their efficacy and toxicity in patients with metastatic kidney cancer.

ReferenceCitation: van Erp NP, Gelderblom H, Guchelaar HJ. Clinical pharmacokinetics of tyrosine kinase inhibitors. Cancer Treat Rev. 2009 Dec;35(8):692-706. doi: 10.1016/j.ctrv.2009.08.004. Epub 2009 Sep 5.

ReferenceCitation: Hendrayana T, Wilmer A, Kurth V, Schmidt-Wolf IG, Jaehde U. Anticancer Dose Adjustment for Patients with Renal and Hepatic Dysfunction: From Scientific Evidence to Clinical Application. Sci Pharm. 2017 Feb 27;85(1):8. doi: 10.3390/scipharm85010008.

ReferenceCitation: Verheijen RB, Bins S, Mathijssen RH, Lolkema MP, van Doorn L, Schellens JH, Beijnen JH, Langenberg MH, Huitema AD, Steeghs N; Dutch Pharmacology Oncology Group. Individualized Pazopanib Dosing: A Prospective Feasibility Study in Cancer Patients. Clin Cancer Res. 2016 Dec 1;22(23):5738-5746. doi: 10.1158/1078-0432.CCR-16-1255. Epub 2016 Jul 28.

ReferenceCitation: Lacy S, Yang B, Nielsen J, Miles D, Nguyen L, Hutmacher M. A population pharmacokinetic model of cabozantinib in healthy volunteers and patients with various cancer types. Cancer Chemother Pharmacol. 2018 Jun;81(6):1071-1082. doi: 10.1007/s00280-018-3581-0. Epub 2018 Apr 23.

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole

location_facility: CHU de Nîmes, Institut de Cancérologie du Gard


title: Oral Care and Cancer: Assessing the Contribution of Training Healthcare Teams to Support the Oral Status of Patients Hospitalized in Palliative Situation

summary: The purpose of this study is to measure the impact of training on the practical assessment and management of the oral status of patients hospitalized in palliative situation.

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
Ligue contre le cancer, France

location_facility:
Centre Oscar Lambret
Centre François Baclesse
Centre Henri Becquerel
Institut de Cancérologie de l'Ouest


title: The Influence of Manual Therapy Applied to the Cervical Spine (Versus Light Touch) in the Prevention of Balance Disorders in the Elderly: a Randomized Controlled Trial

acronym: ManEq

summary: Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Some recognized effective treatments exist, concerning in particular the re-education of the muscles of the lower limbs. However, to our knowledge, none of them focus on the cervical spine although the latter is located at an essential physiological crossroads. Manual therapy, which has already demonstrated its impact on pain and balance parameters in the elderly, could be a painless and non-invasive tool of choice in addressing this problem.

ReferenceCitation: Pinloche L, Souvignet S, Germain M, Monteil K, Hautier C. The short-term effect of a myofascial protocol versus light touch applied to the cervical spine towards the prevention of balance disorders in the elderly: protocol of a randomised controlled trial. Chiropr Man Therap. 2022 Aug 31;30(1):33. doi: 10.1186/s12998-022-00446-0.

lead_sponsor: EZUS-LYON 1


title: A Double-Blind, Placebo-controlled Study on the Effects of MIN-102 on Biochemical, Imaging, Neurophysiological, and Clinical Markers in Patients With Friedreich's Ataxia

acronym: FRAMES

summary: Randomized, double-blind, placebo-controlled study on the effects of MIN-102 on Biochemical, Imaging, neurophysiological, and clinical markers in patients with Friedreich's Ataxia

lead_sponsor: Minoryx Therapeutics, S.L.

location_country: Germany Spain Belgium France

location_facility: ICM, Groupe Hospitalier Pitié Salpêtrière


acronym: SALUTOX

lead_sponsor: Direction Centrale du Service de Santé des Armées

summary: The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.

location_facility: Institut Universitaire de Réadaptation Clémenceau

title: Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

source: euctr


title: A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis

summary: The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

ReferenceCitation: Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3):e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May.

repositories_institution: Max-Delbrueck-Center for Molecular Medicine - MDC Repository

lead_sponsor: AB Science

location_country: Germany Poland Romania Spain Greece Bulgaria France

location_facility: "St. Ivan Rilski" University Multiprofile Hospital for Active Treatment


title: A Prospective, Multicenter, Randomized, Open-label, Active Controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Dacarbazine in the Treatment of Patients With Non-resectable or Metastatic Stage 3 or Stage 4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of C-kit

summary: The objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit and who have not previously been treated for melanoma.

location_country:
Germany
Italy
United States
Spain
Czechia
Russian Federation
France

location_facility: Klinik und Poliklinik für Hautkrankheiten

location_facility: N.N.Blokhin Russian Cancer Research Centre