title: Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®) (2mg) Over a 12-week Period for Patients Suffering From Neovascular Age-related Macular Degeneration (AMD) French SD OCT in wAMD

acronym: START

summary: Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for patients suffering from neovascular age-related-macular degeneration.1 This early dramatic reduction in CRT is already observed through week 4. Therefore it might be not necessary to consistently perform each of the three monthly consecutive intravitreal injections of the so-called loading phase.

ReferenceCitation: Patel KH, Chow CC, Rathod R, Mieler WF, Lim JI, Ulanski LJ 2nd, Leiderman YI, Arun V, Chau FY. Rapid response of retinal pigment epithelial detachments to intravitreal aflibercept in neovascular age-related macular degeneration refractory to bevacizumab and ranibizumab. Eye (Lond). 2013 May;27(5):663-7; quiz 668. doi: 10.1038/eye.2013.31. Epub 2013 Apr 5.

ReferenceCitation: Cruess AF, Zlateva G, Xu X, Soubrane G, Pauleikhoff D, Lotery A, Mones J, Buggage R, Schaefer C, Knight T, Goss TF. Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study. Pharmacoeconomics. 2008;26(1):57-73.

ReferenceCitation: Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31.

ReferenceCitation: Cohen SY, Souied EH, Weber M, Dupeyron G, de Pouvourville G, Lievre M, Ponthieux A. Patient characteristics and treatment of neovascular age-related macular degeneration in France: the LUEUR1 observational study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):521-7. doi: 10.1007/s00417-010-1553-0. Epub 2010 Nov 6.

ReferenceCitation: Heier JS, Boyer D, Nguyen QD, Marcus D, Roth DB, Yancopoulos G, Stahl N, Ingerman A, Vitti R, Berliner AJ, Yang K, Brown DM; CLEAR-IT 2 Investigators. The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. Ophthalmology. 2011 Jun;118(6):1098-106. doi: 10.1016/j.ophtha.2011.03.020. Erratum in: Ophthalmology. 2011 Sep;118(9):1700.

ReferenceCitation: Korobelnik JF, Souied EH, Oubraham H, Razavi S, Mauget-Faÿsse M, Savel H, Chene G, Wolf S. ASSESSMENT OF EARLY CHANGES IN SPECTRAL DOMAIN-OPTICAL COHERENCE TOMOGRAPHY AFTER INITIATION OF TREATMENT WITH INTRAVITREAL AFLIBERCEPT (EYLEA) OVER A 12-WEEK PERIOD FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Multicenter French Study (START). Retina. 2021 Mar 1;41(3):588-594. doi: 10.1097/IAE.0000000000002910.

location_facility: Centre Ophtalmologie Transparence 30 Boulevard Heurteloup

location_facility: Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908

location_facility: Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré

location_facility: Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin

location_facility: Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun

location_facility: Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle

location_facility: Service d'Ophtalmologie Hôpital de la croix rousse

location_facility: Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau

location_facility: Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve

location_facility: Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard


title: Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy

summary:
Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. The rational is the fact that 15% of patients have sterilized tumours after radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm) received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized between local and rectal excision. The main findings were: the rate of complete pathologic response was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15% ypT0) and good pathologic responders (ypT0-1) were associated with zero positive mesorectal nodes.

The objective of the new trial is to increase the proportion of patients treated with organ preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox has been shown to enhance the response rate. In patients with colorectal metastases, response rate and R0 resection were twice higher, resulting in improved survival. Folfirinox also increases response and chance of R0 resection rates in initially unresectable colorectal metastases, compared to standard or intensified bi-chemotherapy regimens. Adding two months of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the investigators expect to increase chance of organ preservation rate, as compared to radiochemotherapy alone.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de Chirurgie Digestive, Hôpital Saint-Antoine - APHP

location_facility: Département de chirurgie digestive, Institut Gustave Roussy

location_facility: Service de Chirurgie Digestive,Institut de Cancérologie de Lorraine

location_facility: Service de Chirurgie Digestive, Centre Oscar Lambret - Lille

location_facility: Service de Chirurgie Digestive, Centre Georges François Leclerc - Dijon

location_facility: Service de Chirurgie Digestive, CHU Amiens Picardie

location_facility: Service de Chirurgie Digestives, Hôpital Européen de Marseille

location_facility: Service de Chirurgie Digestive, Institut Bergonié

location_facility: Service de Chirurgie Digestive, Hôpital Purpan - CHU de Toulouse

location_facility: Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre - APHP

location_facility: Service de Chirurgie Digestive, Hôpital les Diaconnesses

location_facility: Service de Chirurgie Digestive, Institut Paoli Calmette - Marseille

location_facility: Service de Chirurgie Digestive, Hôpital Albert Michallon - CHU de Grenoble

location_facility: Service de Chirurgie Digestive, Hôpital Pontchaillou - CHU Rennes

location_facility: Service de Chirurgie Digestive, Hôpital Charles Nicolle - CHU de Rouen

location_facility: Service d'Oncologie et Radiothérapie, Centre Azuréen de Cancérologie

location_facility: Service de chirurgie digestive, CHRU de Nancy -Hôpital de Brabois

location_facility: Service de Chirurgie Digestive, CHU Carémeau - Nîmes

location_facility: Service de Chirurgie Digestive, Centre Léon Bérard - Lyon

location_facility: Service de Chirurgie Digestive, Hôtel Dieu - CHU de Nantes

location_facility: Service de Chirurgie Digestive, CHU de Besançon

location_facility: Service de Chirurgie Digestive, Hôpital Lyon Sud - CHU Lyon

location_facility: Service de Chirurgie Digestive, Hôpital Beaujon - APHP

location_facility: Service de Chirurgie Digestive, Hôpital Saint-Louis - APHP Paris

location_facility: Service de Chirurgie Digestive, Institut du Cancer de Montpellier

location_facility: Service de Chirurgie Digestive, Hôpital Saint-André - CHU de Bordeaux

location_facility: Service de Chirurgie Digestive, CHU de la Timone - Marseille

location_facility: Service de Chirurgie Digestive, CHU Estaing - CHRU Clermont Ferrand

intervention_type: Radiation

lead_sponsor_type: academique

status_simplified: Ongoing


title: Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib

acronym: STIM 2

summary:
Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials.

Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease.

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Anticipated

location_facility: Lille University hospital - Hôpital Claude Huriez

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: CH Régional de l'ILE DE LA REUNION/ Groupe Hospitalier Sud

location_facility: University Hospital Bordeaux, Hôpital du Haut Lévêque

location_facility: University Hospital Poitiers - Hôpital Jean Bernard

intervention_type: Drug

status_simplified: Completed


title: Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction and Post-remission Chemotherapy in Older Patients With Acute Myeloid Leukaemia, and Feasibility of Allogeneic Transplantation for Patients From 60 to 65 Years Old

acronym: LAM-SA 2007

summary: A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.

ReferenceType: background

ReferenceCitation: Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, Anderson JE, Petersdorf SH. Age and acute myeloid leukemia. Blood. 2006 May 1;107(9):3481-5. Epub 2006 Feb 2.

ReferenceCitation: Sekeres MA, Stone R. Older adults with acute myeloid leukemia. Curr Oncol Rep. 2002 Sep;4(5):403-9. Review.

ReferenceCitation: Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E 3rd. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B. N Engl J Med. 1994 Oct 6;331(14):896-903.

ReferenceCitation: Stone RM, Berg DT, George SL, Dodge RK, Paciucci PA, Schulman P, Lee EJ, Moore JO, Powell BL, Schiffer CA. Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia. Cancer and Leukemia Group B. N Engl J Med. 1995 Jun 22;332(25):1671-7.

ReferenceCitation: Witz F, Sadoun A, Perrin MC, Berthou C, Brière J, Cahn JY, Lioure B, Witz B, François S, Desablens B, Pignon B, Le Prisé PY, Audhuy B, Caillot D, Casassus P, Delain M, Christian B, Tellier Z, Polin V, Hurteloup P, Harousseau JL. A placebo-controlled study of recombinant human granulocyte-macrophage colony-stimulating factor administered during and after induction treatment for de novo acute myelogenous leukemia in elderly patients. Groupe Ouest Est Leucémies Aiguës Myéloblastiques (GOELAM). Blood. 1998 Apr 15;91(8):2722-30.

ReferenceCitation: Pigneux A, Perreau V, Jourdan E, Vey N, Dastugue N, Huguet F, Sotto JJ, Salmi LR, Ifrah N, Reiffers J. Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results. Haematologica. 2007 Oct;92(10):1327-34.

ReferenceCitation: Takagi K. [Neurophysiological and clinical aspects of autonomic centers: introduction]. Nihon Seirigaku Zasshi. 1972 May;34(5):257-61. Japanese.

ReferenceCitation: Gardin C, Turlure P, Fagot T, Thomas X, Terre C, Contentin N, Raffoux E, de Botton S, Pautas C, Reman O, Bourhis JH, Fenaux P, Castaigne S, Michallet M, Preudhomme C, de Revel T, Bordessoule D, Dombret H. Postremission treatment of elderly patients with acute myeloid leukemia in first complete remission after intensive induction chemotherapy: results of the multicenter randomized Acute Leukemia French Association (ALFA) 9803 trial. Blood. 2007 Jun 15;109(12):5129-35. Epub 2007 Mar 6.

ReferenceCitation: Hegenbart U, Niederwieser D, Sandmaier BM, Maris MB, Shizuru JA, Greinix H, Cordonnier C, Rio B, Gratwohl A, Lange T, Al-Ali H, Storer B, Maloney D, McSweeney P, Chauncey T, Agura E, Bruno B, Maziarz RT, Petersen F, Storb R. Treatment for acute myelogenous leukemia by low-dose, total-body, irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors. J Clin Oncol. 2006 Jan 20;24(3):444-53. Epub 2005 Dec 12.

ReferenceType: derived

ReferenceCitation: Largeaud L, Cornillet-Lefebvre P, Hamel JF, Dumas PY, Prade N, Dufrechou S, Plenecassagnes J, Luquet I, Blanchet O, Banos A, Béné MC, Bernard M, Bertoli S, Bonmati C, Fornecker LM, Guièze R, Haddaoui L, Hunault M, Ianotto JC, Jourdan E, Ojeda M, Peterlin P, Vey N, Zerazhi H, Yosr H, Mineur A, Cahn JY, Ifrah N, Récher C, Pigneux A, Delabesse E; French Innovative Leukemia Organization (FILO). Lomustine is beneficial to older AML with ELN2017 adverse risk profile and intermediate karyotype: a FILO study. Leukemia. 2021 May;35(5):1291-1300. doi: 10.1038/s41375-020-01031-1. Epub 2020 Sep 18.

location_facility: Service Médecine B - Unité Onco-hématologique, CHU Caremeau

location_facility: Service des maladies du sang, Centre Hospitalier Universitaire d'Angers

location_facility: Service Hématologie Clinique, Hôpital Bretonneau

location_facility: Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon

location_facility: Service Hématologie Clinique, Hôpital Archet 1

location_facility: Service Onco-Hématologie 3, Institut Paoli Calmettes

location_facility: Service d'Hématologie, Institut de Cancérologhie de la Loire

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque

location_facility: Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble

location_facility: Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand

location_facility: Service Oncologie Médicale, Hôpital de la Source

location_facility: Service Hématologie Clinique, CHU Dijon Hôpital des enfants

location_facility: Service Hématologie, Centre Hospitalier Annecy

location_facility: Service Hématologie - Médecine Interne, Hôpitaux de Brabois

location_facility: Service Hématologie Clinique, Hôpital Robert Debre

location_facility: Unité Hématologie, Centre Hospitalier Blois

location_facility: Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar

location_facility: Service Hématologie Oncologie, CHR Metz-Thionville

location_facility: Service Hématologie Clinique, Hôpital Pontchaillou

location_facility: Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens

location_facility: Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre

location_facility: Service Hématologie, Hôpital Dr Duchenne

location_facility: Service Hématologie, Hôpital Augustin Morvan

location_facility: Service Hématologie, Centre Hospitalier de la Côte Basque

location_facility: Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier

location_facility: Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse

location_facility: Service Hématologie Clinique, CHU -Hôtel Dieu


title: Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)

acronym: STIM

summary: The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.

design_allocation: Non-Randomized

ReferenceCitation: Rea D, Henry G, Khaznadar Z, Etienne G, Guilhot F, Nicolini F, Guilhot J, Rousselot P, Huguet F, Legros L, Gardembas M, Dubruille V, Guerci-Bresler A, Charbonnier A, Maloisel F, Ianotto JC, Villemagne B, Mahon FX, Moins-Teisserenc H, Dulphy N, Toubert A. Natural killer-cell counts are associated with molecular relapse-free survival after imatinib discontinuation in chronic myeloid leukemia: the IMMUNOSTIM study. Haematologica. 2017 Aug;102(8):1368-1377. doi: 10.3324/haematol.2017.165001. Epub 2017 May 18.

ReferenceCitation: Mahon FX, Réa D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Français des Leucémies Myéloïdes Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.

location_facility: Centre hospitalier-service de médecine interne Onco-Hématologique

location_facility: University Hospital Strasbourg, Hôpital Civil

location_facility: University Hospital Bordeaux, Groupe Hospitalier Pellegrin

intervention_type: Behavioral


title: Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)

acronym: PHARMA-A

summary: The Pharm A project is a French national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years.

ReferenceCitation: Bui S, Facchin A, Ha P, Bouchet S, Leroux S, Nacka F, Fayon M, Jacqz-Aigrain E. Population pharmacokinetics of ceftazidime in critically ill children: impact of cystic fibrosis. J Antimicrob Chemother. 2020 Aug 1;75(8):2232-2239. doi: 10.1093/jac/dkaa170.

location_facility:
AP-HP - Hôpital Robert Debré
CHU de Bordeaux, Hôpital Pellegrin
CHU Clermont Ferrand
CHU Montpellier
CHU Poitiers
CHU Rouen
CHU de Grenoble
CHU Toulouse
CHU de Dijon
CHU tours
APHP - Hôpital NEcker
Hospices Civils de Lyon
AP-HM, Hôpital La Timone
CHRU Lille


title: Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study

acronym: DOCTORS

summary:
Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting. - To date, no study has evaluated whether optical coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention (PCI) and stenting.

The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided angioplasty would provide useful clinical information beyond that obtained by angiography, and whether this information would subsequently modify physician behavior and treatment choices. In particular, we will evaluate the impact of changes in procedural strategy resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after angioplasty and stent implantation of a lesion responsible for non-ST segment elevation acute coronary syndromes.

ReferenceCitation: Meneveau N, Ecarnot F, Souteyrand G, Motreff P, Caussin C, Van Belle E, Ohlmann P, Morel O, Grentzinger A, Angioi M, Chopard R, Schiele F. Does optical coherence tomography optimize results of stenting? Rationale and study design. Am Heart J. 2014 Aug;168(2):175-81.e1-2. doi: 10.1016/j.ahj.2014.05.007. Epub 2014 May 24.

ReferenceType: result

ReferenceCitation: Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrançois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.

ReferenceCitation: Meneveau N, Ecarnot F. Response by Meneveau and Ecarnot to Letter Regarding Article, "Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients With Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting)". Circulation. 2017 Feb 28;135(9):e142-e143. doi: 10.1161/CIRCULATIONAHA.116.026277.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire Régional

intervention_type: Procedure


type: Other Identifier

title: On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men

acronym: IPERGAY

summary: This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel groups is designed to evaluate a strategy for the prevention of HIV infection including "on demand" antiretroviral pre-exposure with Truvada versus placebo, associated with overall prevention (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed recent studies have reported a higher incidence of new HIV infection in MSM as compared to the general population, new approaches to the prevention of HIV infection are, therefore, necessary in order to consider the limits of current strategies.

primary_purpose: Prevention

ReferenceCitation: Antoni G, Tremblay C, Delaugerre C, Charreau I, Cua E, Rojas Castro D, Raffi F, Chas J, Huleux T, Spire B, Capitant C, Cotte L, Meyer L, Molina JM; ANRS IPERGAY study group. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV. 2020 Feb;7(2):e113-e120. doi: 10.1016/S2352-3018(19)30341-8. Epub 2019 Nov 26.

ReferenceCitation: Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bébéar C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Doré V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8.

ReferenceCitation: Molina JM, Charreau I, Spire B, Cotte L, Chas J, Capitant C, Tremblay C, Rojas-Castro D, Cua E, Pasquet A, Bernaud C, Pintado C, Delaugerre C, Sagaon-Teyssier L, Mestre SL, Chidiac C, Pialoux G, Ponscarme D, Fonsart J, Thompson D, Wainberg MA, Doré V, Meyer L; ANRS IPERGAY Study Group. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV. 2017 Sep;4(9):e402-e410. doi: 10.1016/S2352-3018(17)30089-9. Epub 2017 Jul 23.

ReferenceCitation: Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Préau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Doré V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_country: Canada France

location_facility:
Hôpital de La Croix Rousse
Hôpital de l'Archet
Hôpital Gustave Dron
CHUM - Hôpital Hôtel Dieu
Hôpital Tenon
Hôpital Saint-Louis
CHU Hôtel Dieu


title: LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable Hepacellular Carcinoma

summary: The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: de Baere T, Guiu B, Ronot M, Chevallier P, Sergent G, Tancredi I, Tselikas L, Dioguardi Burgio M, Raynaud L, Deschamps F, Verset G. Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: PARIS Registry. Cancers (Basel). 2020 Nov 17;12(11). pii: E3405. doi: 10.3390/cancers12113405.

ipd_sharing: Undecided

lead_sponsor: Terumo Europe N.V.

location_country: France Belgium

location_facility:
Hôpital Universitaire Saint-Eloi
Hôpital Erasme
Cliniques Universitaires Saint Luc
Hôpital Beaujon
Hôpital L'Archet II
Institut Gustave Roussy
CHRU Lille

intervention_type: Device

lead_sponsor_type: industriel


title: Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer

summary:
Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity.

Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen.

Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen

status: Unknown status

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

status_simplified: Unknown


status: Recruiting

title: Randomized, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Masitinib Combined With Isoquercetin, and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19

lead_sponsor: AB Science

type: EudraCT Number

source: euctr

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.

location_facility: CHU Clermont-Ferrand: Site Gabriel-Montpied

location_facility: Le Tripode, Groupe hospitalier Pellegrin CHU de Bordeaux

summary: Study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin in adult hospitalized patients with moderate and severe COVID-19.


title: BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication

acronym: BioCONTINUE

summary:
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question.

80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device.

So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.

lead_sponsor: Biotronik SE & Co. KG

location_country: Portugal Spain Italy Hungary France Israel Belgium Germany

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Cliniques du Tonkin, de la Sauvegarde et Protestante

location_facility: Hospital Universitario Marques de Valdecilla


title: Assessment of the Numen Stent With Evaluation in a Randomized Study

acronym: ANSWERS

summary: The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native coronary arteries and compare it to the VISION/MINIVISION coronary stent

lead_sponsor: International Biomedical Systems S.p.A.

location_facility:
Clinique Saint Gatien
Clinique Vert Coteau
Centre Hospitalier Privé Beauregard
Clinique Turin
Clinique Alleray-Labrouste
Clinique Valmente
CMC De Parly II
CHU Cote de Nacre


title: Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

acronym: TRAUMAX

summary: The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX

lead_sponsor: Integra LifeSciences Services

location_facility: Hôpital d'Instruction des Armées R. Picqué

location_facility: Nouvelle Clinique de l'Union et du Vaurais

location_facility: Centre Hospitalier Départemental de Vendée


title: Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.

summary: The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).

lead_sponsor: Terumo BCTbio

location_facility: Centre Hospitalier Régional Universitaire Hautepierre

location_facility: Centre Hospitalier Univesrsitaire A Michallon

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire Hôtel Dieu

location_facility: Centre Hospitalier Universitaire Jean Minjoz


title: During-exercise Physiological Effects of Nasal High-flow in Patients With Chronic Obstructive Pulmonary Disease

acronym: AIRVO-PHYSIO

summary:
Chronic obstructive pulmonary disease is a major cause of disability and mortality worldwide. This disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation teaches chronic obstructive pulmonary disease patients to cope effectively with the systemic effects of the disease and improves exercise capacity, dyspnea and quality of life in patients with chronic obstructive pulmonary disease. However, the best training modality remains unknown. Physiological studies highlight the benefit of high intensity endurance training. However, many patients do not tolerate such a training due to ventilatory limitation and dyspnea. Therefore, a strategy to reduce dyspnea would allow a greater physiological muscle solicitation and improvement. Thus, many studies focus on means to increase exercise tolerance in patients with chronic obstructive pulmonary disease.

Nasal high flow delivers heated and humidified high flow air (up to 60 L/min) through nasal cannula providing physiological benefits such as positive airway pressure and carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.

More recently, nasal-high flow has been shown to improve endurance exercise capacity in patients with chronic obstructive pulmonary disease. However, the underlying physiological mechanisms have not been yet elucidated but may help to optimise the utilization of the device.

Therefore, the primary objective of this study is to assess the respiratory physiological effects nasal high-flow during-exercise in stable patients with chronic obstructive pulmonary disease.

Secondary objectives are to assess the effects nasal high-flow during-exercise on endurance capacity, respiratory drive, dynamic hyperinflation, cardiorespiratory pattern and muscular metabolism.

lead_sponsor: ADIR Association

intervention_type: Other


title: Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease - A Randomized Controlled Study

acronym: PPR-NHF

summary:
Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. However, its benefits progressively fade over time due to several factors such as the lack of regular exercise activity, dyspnea, airway secretions, hematosis impairment and acute exacerbations which can lead to hospitalization and accelerated muscle wasting.

Nasal high flow (NHF) is a support used to deliver heated and humidified high flow air (up to 60 L/min) through nasal canula providing promising physiological benefits such as positive airway pressure or upper airway carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.

More recently, several studies have shown that long-term nasal high flow could contribute to improve exercise capacity, dyspnea, airway secretion removal, hematosis, reduced acute exacerbations and subsequent hospitalizations in patients with COPD.

Based on these results, the primary aim of this study is to assess whether long-term nasal high flow treatment can help COPD patients to better maintain their endurance capacity following a course of pulmonary rehabilitation.


title: Early Immunological, Metagenomic, Metabolic and Environmental Factors in the Progression to Type 1 Diabetes: the TRAKR Cohort

acronym: TRAKR

summary: The purpose of this study is to determine whether early immunological markers (activation of autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in children born from type 1 diabetic parents.

primary_purpose: Screening

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Biological


title: A Phase II Multicenter, Open-Label, Clinical And Pharmacokinetic Study of Aplidin® As A 1-Hour Weekly IV Infusion, in Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

summary: This is a multicenter study to assess the anti-tumour activity,to investigate the safety profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.

ReferenceCitation: Ribrag V, Caballero D, Fermé C, Zucca E, Arranz R, Briones J, Gisselbrecht C, Salles G, Gianni AM, Gomez H, Kahatt C, Corrado C, Szyldergemajn S, Extremera S, de Miguel B, Cullell-Young M, Cavalli F. Multicenter phase II study of plitidepsin in patients with relapsed/refractory non-Hodgkin's lymphoma. Haematologica. 2013 Mar;98(3):357-63. doi: 10.3324/haematol.2012.069757. Epub 2012 Oct 12.

lead_sponsor: PharmaMar

location_country:
Spain
Italy
Switzerland
Puerto Rico
Peru
France

location_facility: Hospital Español Auxilio Mutuo de Puerto Rico Inc.

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Instituto Nacional de Enfermedades Neoplásicas (INEN)

location_facility: Istituto di ematologia e oncologia medica "L. e. A. Seragnoli"

location_facility: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni


acronym: MS-SPI

title: Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study

lead_sponsor: MedDay Pharmaceuticals SA

location_facility: Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye

summary: The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.


title: A Randomized Phase II Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

summary: A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with or without adjuvant, in HIV-infected patients after one or two injections.

location_facility: Hôpital Gustave Dron, Service Maladies Infectieuses

location_facility: Hopital du Kremlin Bicêtre Service de médecine interne

location_facility: Service des Maladies Infectieuses et Tropicales, Hopital Tenon

location_facility: CIC de Vaccinologie Cochin Pasteur, hôpital Cochin


title: Alterations in Total Red Blood Cell Volume and Plasma Volume During a One-year Confinement in Antarctica: Effect of Hypoxia

acronym: ANTARCV

summary: This study evaluates the effect of hypoxia on blood volumes during Antarctic winter-over confinement. Half of the participants will be evaluated during sea-level winter-over confinement, while the other half will be examined during high-altitude hypoxia winter-over confinement.

status: Enrolling by invitation

primary_purpose: Basic Science

lead_sponsor: Ecole Nationale des Sports de Montagne

location_facility: Ecole nationale des sports de montagne, site de l'Ecole nationale de ski et d'alpinisme


title: A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort Study in Subjects With Female Stress Urinary Incontinence

summary: The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device implantation in women with stress urinary incontinence.

lead_sponsor: Coloplast A/S

location_country: Spain Italy France Belgium Germany

location_facility: Clinique Mutualiste de la Porte de l'Orient


title: Recombinant Human Activated Factor VII as Salvage Therapy in Women With Severe Postpartum Hemorrhage

summary: The aim of this clinical research project is to evaluate the use of the recombinant human activated factor VII (rhFVIIa), given as a salvage therapy, in women with a dramatic postpartum hemorrhage still ongoing after all the currently available medical and surgical treatments. We are going to compare its early use, before elective surgery or arterial embolization, to its late use, after embolization or surgery, before salvage hysterectomy.

ReferenceCitation: Lavigne-Lissalde G, Aya AG, Mercier FJ, Roger-Christoph S, Chauleur C, Morau E, Ducloy-Bouthors AS, Mignon A, Raucoules M, Bongain A, Boehlen F, de Moerloose P, Bouvet S, Fabbro-Peray P, Gris JC. Recombinant human FVIIa for reducing the need for invasive second-line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial. J Thromb Haemost. 2015 Apr;13(4):520-9. doi: 10.1111/jth.12844. Epub 2015 Mar 11.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_country: France Switzerland

location_facility: Laboratoire d'hématologie, Groupe Hospitalo-Universitaire Caremeau


title: Randomized, Placebo-controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib at 6 mg/kg/Day to Placebo in Treatment of Patients With Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis With Handicap

ReferenceCitation: Arock M. A new therapeutic advance for symptomatic systemic mastocytosis? Lancet. 2017 Feb 11;389(10069):576-578. doi: 10.1016/S0140-6736(16)31655-5. Epub 2017 Jan 7.

ReferenceCitation: Lortholary O, Chandesris MO, Bulai Livideanu C, Paul C, Guillet G, Jassem E, Niedoszytko M, Barete S, Verstovsek S, Grattan C, Damaj G, Canioni D, Fraitag S, Lhermitte L, Georgin Lavialle S, Frenzel L, Afrin LB, Hanssens K, Agopian J, Gaillard R, Kinet JP, Auclair C, Mansfield C, Moussy A, Dubreuil P, Hermine O. Masitinib for treatment of severely symptomatic indolent systemic mastocytosis: a randomised, placebo-controlled, phase 3 study. Lancet. 2017 Feb 11;389(10069):612-620. doi: 10.1016/S0140-6736(16)31403-9. Epub 2017 Jan 7.

location_country:
United States
France

location_facility: UC Davis Health System , Department of Dermatology

summary: The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.


title: Multicentric Study of the Clinical Interest of the TcPO2 Technique

acronym: CINEYSOFT

summary:
The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded.

The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.

status: Terminated

lead_sponsor: University Hospital, Angers

location_facility:
Hospital
University Hospital


title: Phase 2 of Sunitinib (Sutent) in Patients With Locally Advanced or Metastatic Anaplastic, Differentiated or Medullar Thyroid Cancer

acronym: THYSU

summary:
Due to arguments showing that angiogenesis could be involved in progression of metastatic thyroid carcinoma and to objective response during previous studies with sunitinib (an angiogenic oncology drug also known as Sutent), this study, THYSU, is justified to evaluate the efficacy of sunitinib in metastatic thyroid carcinoma. Furthermore, the standard treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is limited to radioiodine. When radioiodine becomes ineffective, there is no standard treatment despite some use of chemotherapy.

The objective of the trial is to determine the objective tumor response rate (efficacy) in patients with locally advanced or metastatic anaplastic, differentiated or medullary thyroid carcinoma treated with sunitinib; a secondary objective is to evaluate the safety of sunitinib in these patients.

The THYSU trial is a phase II, French multi-center study. This trial's plan is to enroll 75 patients with locally advanced or metastatic anaplastic, differentiated or medullar thyroid carcinoma.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Léon Bérard - Département de Médecine - 28 rue Laennec

location_facility: Service d'Endocrinologie - Hôpital de l'Archet I - Route Saint Antoine de Jinestière

location_facility: Service d'Oncologie Médicale, Institut Claudius Regaud - 20-24 rue du Pont Saint Pierre

location_facility: Centre Antoine Lacassagne - 33 avenue de Valombrose

location_facility: Service de Cancérologie Médicale - HEGP - 20 rue Leblanc

location_facility: Service des Maladies Endocriniennes - Hôpital Lapeyronie - 191 avenue du Doyen Gaston Giraud

location_facility: Service d'endocrinologie et Maladies Métaboliques, Groupe Hospitalier Rangueil-Larrey CHU Toulouse - avenue Prof Jean Poulhes

location_facility: Centre Paul Lamarque - Va d'Aurelle - CRLC Val d'Aurelle - 208 rue des Apothicaires

location_facility: Service d'Endocrinologie - CHU de Nancy, Hôpital de Brabois - rue du Morvan

location_facility: Service d'Endocrinologie et maladies métaboliques, Clinique Marc Linquette - rue du Pr Laguesse

location_facility: Service d'Endocrinologie, CHU Timone, AP-HM - 254 rue St Pierre

location_facility: Département Endocrinolo-Diabéto-Nutrition - CHU d'Angers - 4 rue de Larray

location_facility: Fédération Endocrinologie - Groupe Hospitalier Est - Hôpital neurologique - CHU Lyon - 59 Boulevard Pinel

location_facility: Service d'Oncologie Médicale et de Radiothérapie - Hôpital Saint André - 1 rue Jean Burguet


acronym: CAPADOGE

summary: The investigators will propose to older cancer patients with good prognosis (curative care) a randomized trial of adapted physical activity during one year. To increase generalisation of the intervention the investigators intend to compare the PNNS advices (the French National Nutrition and Health Program) to a program targeted on the own capacities of each patient.

location_facility:
Institut Bergonié
CHU Bordeaux - hôpital Xavier Arnozan
CH Mont de Marsan
Institut jean Godinot, CLCC Reims
CHU de Limoges, Hôpital Dupuytren
CHU de Bordeaux - Hôpital Saint André
Centre Oscar Lambret, CLCC Lille
CH de Dax
CHU Nancy hôpital adulte du brabois
CHRU Lille
Centre hospitalier de Senlis
Centre Alexis Vautrin CLCC Nancy


summary: The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population

lead_sponsor: Pierre Fabre Medical Devices


title: An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.

acronym: COMET

summary:
The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.

primary_purpose: Health Services Research

ReferenceCitation: Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9:CD009437. doi: 10.1002/14651858.CD009437.pub3. Review.

ReferenceCitation: Kessler R, Casan-Clara P, Koehler D, Tognella S, Viejo JL, Dal Negro RW, Díaz-Lobato S, Reissig K, Rodríguez González-Moro JM, Devouassoux G, Chavaillon JM, Botrus P, Arnal JM, Ancochea J, Bergeron-Lafaurie A, De Abajo C, Randerath WJ, Bastian A, Cornelissen CG, Nilius G, Texereau JB, Bourbeau J. COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD. Eur Respir J. 2018 Jan 11;51(1). pii: 1701612. doi: 10.1183/13993003.01612-2017. Print 2018 Jan.

lead_sponsor: Air Liquide Santé International

location_country: Germany France Spain Italy

location_facility: Azienda Ospedaliera, "Ospedale San Carlo Borromeo"

location_facility: Universitätsklinikum Ulm, - Klinik Innere Medizin II

location_facility: Hôpitaux Civils de Colmar - Hôpital Pasteur

location_facility: Azienda ULSS 22 - Ospedale di Bussolengo

location_facility: Centre Hospitalier d Antibes Juans-les-pins

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord


title: Randomized Clinical Trial Evaluating the Efficacy of Methotrexate in Addition to Anti-H1 Versus Placebo and Anti-H1 in the Treatment of Severe Chronic Idiopathic Urticaria

acronym: MUCIS

summary: Chronic urticaria is defined by urticarial lesions persisting at 6 weeks. The cause is not found in about 75% of cases (chronic idiopathic urticaria). The gold standard treatment consists of anti-H1 molecules. In severe cases, refractory to anti-H1, few therapeutic alternatives exist. Methotrexate, which is not expensive and often prescribed by dermatologists, has been efficiently tried in an open study on severe chronic idiopathic urticaria, and also in few case reports.

lead_sponsor: University Hospital, Tours

location_facility:
CHRU POITIERS La Miléterie
CHRU LILLE Huriez
CHRU NANCY Brabois
Chru Reims
Chru Nantes
Hopital TENON
CHRU RENNES Pontchaillou
Ch Le Mans
CHRU BREST Morvan
Chu Mondor
Chru Tours


title: Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial

summary: To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.

ReferenceCitation: Nuytens F, Dabakuyo-Yonli TS, Meunier B, Gagnière J, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrère N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Markar SR, Piessen G; Fédération de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Groups. Five-Year Survival Outcomes of Hybrid Minimally Invasive Esophagectomy in Esophageal Cancer: Results of the MIRO Randomized Clinical Trial. JAMA Surg. 2021 Apr 1;156(4):323-332. doi: 10.1001/jamasurg.2020.7081.

ReferenceCitation: Mariette C, Markar SR, Dabakuyo-Yonli TS, Meunier B, Pezet D, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrère N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Bonnetain F, Piessen G; Fédération de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Group. Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer. N Engl J Med. 2019 Jan 10;380(2):152-162. doi: 10.1056/NEJMoa1805101.

ReferenceCitation: Briez N, Piessen G, Bonnetain F, Brigand C, Carrere N, Collet D, Doddoli C, Flamein R, Mabrut JY, Meunier B, Msika S, Perniceni T, Peschaud F, Prudhomme M, Triboulet JP, Mariette C. Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial. BMC Cancer. 2011 Jul 23;11:310. doi: 10.1186/1471-2407-11-310.

lead_sponsor: University Hospital, Lille

location_facility:
Hopital Ambroise Pare Ap-Hp
Hopital St Louis Ap-Hp
Hopitalpontchaillou
Hopital de La Croix Rousse
Hopital St Marguerite Ap-Hm
Hopital Louis Mourier
Hopitaux Universitaires de Strasbourg
Hopital Du Haut Leveque
Hotel Dieu
Hopital Purpan
Institut Mutualiste Montsouris


title: Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.

summary: The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle

primary_purpose: Other

lead_sponsor: Boston Scientific Corporation

location_facility:
CHU Nantes
CHU Tours
CHU La Timone
Nouvelle Clinique Nantaise
CHU Rangueil
CH St. Joseph
CHU Clermont Ferrand
CH Besancon
CHU Angers
CHU Montpellier
CHU Rouen
CHU Lariboisière
CHU Michalon
CHU Pitié Salpitrière
Hôpital Pontchaillou
CHU Henri Mandor
CH Amiens
HEGP


title: Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

acronym: MVP

summary: Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.

lead_sponsor: Nantes University Hospital

location_facility:
Rennes University Hospital
Nantes University Hospital
Brest University Hospital


title: Clinical Impact of the iBox as an Early Intervention tooL: A Prospective Randomised Controlled Trial to Assess the Use of a Software Predicting Allograft Survival in the Follow-up of Kidney Transplanted Patients.

acronym: CIBIL

summary: International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.

ipd_sharing_description: Data will be communicated to other researchers in an aggregated manner

lead_sponsor: Cibiltech

location_country:
Spain
United Kingdom
Austria
France
Germany

location_facility: Guy's & Saint Thomas' NHS Foundation Trust

location_facility: Hospital Universitari i Politècnic La Fe


title: A Phase I/II Study of Eltrombopag in Patients With Chronic Myelomonocytic Leukemia and Thrombocytopenia

summary: Treatment of patients with chronic myelomonocytic leukemia (CMML) and thrombocytopenia.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: IUCT Oncopole - Service d'Hématologie Clinique

location_facility: Centre Hospitalier de la région d'Annecy

location_facility: Hôpital Saint Louis - Service d'hématologie AJA

location_facility: Hôpital Saint Louis - Service d'hématologie séniors


title: A Phase I-II Trial of Acadesine in IPSS High and Int-2 SMD, LAM With 20-30% Marrow Blasts and CMML Type 2 Not Responding to Azacitidine or Decitabine for at Least 6 Courses or Relapsing After a Response

acronym: Acadesine

summary:
A phase I-II trial of Acadesine in IPSS high and int 2 myelodysplastic syndromes, acute myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not responding to Azacitidine or Decitabine for at least 6 courses or relapsing after a response:

Patients will receive 6 treatment cycles unless disease progression, transformation, or unacceptable toxicity occurs, or the patient refuses to continue participating in the study.

Efficacy will be assessed at the end of the 2nd, 4th and 6th cycles. After 6 cycles, patients demonstrating a response (CR, PR, marrow CR, or HI) will be able to continue with cycles of Acadesine (at the same dose as in the preceding cycles, depending on their cohort) until progression.

location_facility:
Institut paoli calmettes
Centre henri Becquerel
CHU de Haut-Lévèque
Centre henri Mondor
Centre Antoine Lacassagne
Hôpital Saint Antoine
centre hospitalier de Meaux
CHU de Grenoble
CHU de nantes
Hôpital L'archet 1, Nice
Hôpital Saint Louis
Hôpital Cochin
CHU de Limoges
Hôpital Avicenne
Centre hospitalier de la côte Basque
Hôpital Saint-Louis
Hôpital Bretonneau de Tours


title: Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients

acronym: RYTHMODIAL

summary: The purpose of this study is to use implantable loop recorder (ILR) in patients under chronic hemodialysis to record arrhythmias and conduction disorders and correlate them with hemodialysis parameters.

ReferenceCitation: Sacher F, Jesel L, Borni-Duval C, De Precigout V, Lavainne F, Bourdenx JP, Haddj-Elmrabet A, Seigneuric B, Keller A, Ott J, Savel H, Delmas Y, Bazin-Kara D, Klotz N, Ploux S, Buffler S, Ritter P, Rondeau V, Bordachar P, Martin C, Deplagne A, Reuter S, Haissaguerre M, Gourraud JB, Vigneau C, Mabo P, Maury P, Hannedouche T, Benard A, Combe C. Cardiac Rhythm Disturbances in Hemodialysis Patients: Early Detection Using an Implantable Loop Recorder and Correlation With Biological and Dialysis Parameters. JACC Clin Electrophysiol. 2018 Mar;4(3):397-408. doi: 10.1016/j.jacep.2017.08.002. Epub 2017 Sep 27.

location_facility:
Clinique Saint Augustin
CHU de Nantes
CH de Libourne
CHU de Strasbourg
Polyclinique Bordeaux-Nord Aquitaine
University Hospital of Bordeaux
CHU de Toulouse
CH de Haguenau
CHU de Rennes


title: Prospective Therapeutic De-escalation and miRNA-M371 Biomarker Evaluation Phase II Study for Stage IIa/IIb < 3 cm Seminomas

acronym: EDEN

summary:
Phase II, multicenter, prospective, randomized, non-comparative, de-escalation study.

Patients with stage IIa/IIb < 3 cm seminoma histologically proved after orchiectomy will be included in the study and will receive 1 cycle of Etoposide Cisplatine (EP) chemotherapy.

Patients with negative week-3 PET-scan after the EP cycle, will be randomized (1:1 ratio, stratification according to the disease stage (stage IIa versus IIb seminoma)) to receive either radiotherapy (RT) boost on lymph nodes or 1 cycle of carboplatin AUC7 chemotherapy.

Patients with positive week-3 PET-scan will received 3 additional cycles of EP chemotherapy.

In parallel, eligible patients scheduled to receive standard lombo-aortic RT will be registered in an observational cohort.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Leon Berard

location_facility: Institut Universitaire de Cancer de Toulouse (IUCT-O)


title: A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR

acronym: FLARE

summary:
The current first line treatment of patients with EGFR activating mutation lung cancer is EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of response rate and progression-free survival. However, an acquired resistance occurs almost constantly. The second-line treatment includes platinum-based chemotherapy in the absence of contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs.

However, a rebound phenomenon of the disease was described in patients who discontinued EGFR TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI acquired resistance.

It seems therefore useful to conduct a study to better define the therapeutic strategy to adopt in patients developing an acquired resistance after having received EGFR TKIs as first line treatment.

lead_sponsor: Centre Francois Baclesse

location_facility: Hôpital d'instruction des Armées Sainte-Anne


title: Triple-site Biventricular Stimulation in the Optimization of Cardiac Resynchronization Therapy (CRT)

acronym: TRIUMPH-CRT

summary:
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation.

Non-response can be explained by a combination of factors including sub-optimal patient selection, placement of the pacing lead over a zone of slow conduction, insufficient correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data distinguish true non-responders from patients in which effective resynchronization was not delivered through standard biventricular implantation.

Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation Therapy) CRT recipients.

lead_sponsor: MicroPort CRM

location_country: Portugal Spain Italy Netherlands France Germany


title: A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent

summary: The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent.

location_facility:
Chu Morvan
Hopital Felix Guyon
CHRU
Chu Estaing
CHU
Centre Oscar Lambret
Institut Gustave Roussy
Hopital de La Timone
Institut Curie
Hopital Trousseau


title: A Randomized, Open Label, Phase II Trial of Bevacizumab Plus Weekly Paclitaxel Followed by Bevacizumab Monotherapy Maintenance Versus Weekly Paclitaxel Followed by Observation in Patients With Relapsed Ovarian Sex-cord Stromal Tumours

acronym: ALIENOR

summary:
Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood vessels (a process called "angiogenesis"). This can reduce blood flow of the tumor and then decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the tumor from growing.

In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already benefits from a marketing authorization (MMA) for these various types of cancers.

The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is ended.

This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal since this tumors are very well vascularized.

The ALIENOR study aims to explore the interest and the clinical benefit of associating bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords- stromal tumor treated beforehand by platinum chemotherapy

ReferenceCitation: Ray-Coquard I, Harter P, Lorusso D, Dalban C, Vergote I, Fujiwara K, Gladieff L, Lück HJ, Floquet A, Chevalier-Place A, Schnelzer A, Pignata S, Selle F, Sehouli J, Brocard F, Mangili G, Pautier P, De Giorgi U, Provansal M, Heudel PE. Effect of Weekly Paclitaxel With or Without Bevacizumab on Progression-Free Rate Among Patients With Relapsed Ovarian Sex Cord-Stromal Tumors: The ALIENOR/ENGOT-ov7 Randomized Clinical Trial. JAMA Oncol. 2020 Dec 1;6(12):1923-1930. doi: 10.1001/jamaoncol.2020.4574.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon


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. Review. 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.

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. Review. 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. Review.

ReferenceCitation: Montemurro M, Schöffski P, Reichardt P, Gelderblom H, Schütte J, Hartmann JT, von Moos R, Seddon B, Joensuu H, Wendtner CM, Weber E, Grünwald 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, Schöffski 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.

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

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

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.

ReferenceCitation: Nilsson B, Bümming P, Meis-Kindblom JM, Odén 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.

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.

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.

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. 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. Review.

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.

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.

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.

ReferenceCitation: Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarbá 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, Bouché O, Chauzit E, Duffaud F, Bertucci F, Isambert N, Gautier J, Blay JY, Pérol 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.

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


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.

ipd_sharing_description: There is not a plan to make IPD available

location_country: France Italy

location_facility: Centre Hospitalier Chalon Sur Saône William Morey

location_facility: Clinique Mutualiste de la Porte de l'Orient


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.

lead_sponsor: UNICANCER

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

location_facility: Institut de Cancerologie de Lorraine Alexis Vautrin

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

location_facility: INSTITUT DE CANCEROLOGIE Lucien Neuwirth


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.

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:CD005084. doi: 10.1002/14651858.CD005084.pub4.

location_facility: Hospices Civils de Lyon, Hôpital Lyon Sud

location_facility: CHU de Montpellier, Hôpital Gui De Chauliac


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

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. Review.

location_facility: Institut de cancérologie Lucien Neuwirth


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.

lead_sponsor: Centre Oscar Lambret

location_facility:
ICM-Val d'Aurelle
Hôpital Jeanne de Flandre
Institut Paoli Calmettes
Centre Jean Perrin
Institut de Cancérologie de l'Ouest
Clinique Mathilde
Institut de Cancérologie de Lorraine
Hôpital Européen Georges Pompidou
Centre Oscar Lambret
Hôpital de Hautepierre
Centre Henri Becquerel
Institut Gustave Roussy
Centre Hospitalier Lyon Sud
Centre François Baclesse


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.

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.

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.

ReferenceCitation: Machover D, Delmas-Marsalet B, Misra SC, Gumus Y, Goldschmidt E, Schilf A, Frénoy 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.

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.

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.

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.

lead_sponsor: Lymphoma Study Association

location_facility: Service D'Hématologie Adulte - Hôpital Necker

location_facility: Service des Maladies du Sang - CHRU de Lille

location_facility: Service d'Hématologie Clinique - CHU Le Bocage


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).

location_facility: Centre Hospitalier de Purpan - Hôpital des Enfants


title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma.

ipd_sharing: Yes

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Slovenia
Italy
United Kingdom
Australia
Switzerland
France
Netherlands
Czechia

location_facility: Spedali civili Ospedale Dei Bambini Oncoematologia pediatrica e TMO

location_facility: Inselspital, Universitätsklinik für Kinderheilkunde

location_facility: Universitäts-Kinderspital beider Basel (UKBB)

location_facility: Division of Pediatric Oncology Universitäts-Kinderspital Zürich

location_facility: HUG Hôpitaux Universitaires de Genève Unité d'Hémato-Oncologie Pédiatrique

location_facility: Ospedale San Giovanni Pediatria, Emato-oncologia pediatrica

location_facility: University medical center Ljubljana, University Children's Hospital Ljubljana, Slovenia

location_facility: Children's Cancer Centre, Monash Children's Hospital

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois

location_facility: Luzerner Kantonsspital, Kinderspital pädiatrische Hämatologie/Onkologie

location_facility: Oncology/Haematology Department, Perth Children's Hospital

location_facility: Ostschweizer Kinderspital Hämatologie/Onkologie Claudiusstrasse 6

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust

location_facility: Children's Cancer & Haematology Services, John Hunter Children's Hospital

location_facility: Kantonsspital Aarau AG Klinik für Kinder und Jugendliche

location_facility: Australian and New Zealand Children's Hematology/oncology Group

location_facility: Cancer Centre for Children, The Children's Hospital


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.

location_facility: Hôpitaux Universitaires de Strasbourg - NHC

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


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

ReferenceCitation: Cláudio 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. Review.

ReferenceCitation: Clavarino G, Cláudio 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-β 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, Cláudio 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, Aumaître O, Francès C, Le Guern V, Lioté 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, Sacré 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. Review.

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.

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: Rönnelid 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.

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. Review.

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. Review.

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


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: Serbia Spain Italy France Germany

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

location_facility: Institute for Cardiovascular Disease Dedinje

location_facility: Hopital Cardiovasculaire et Pneumologie Louis Pradel

location_facility: Klinikum des Johannes Gutenberg Universität


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, Molé 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.

lead_sponsor: Onxeo

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

location_facility: Egyesített Szent István és Szent László Kórház - Rendelőintézet

location_facility: Hospital General Universitario de Alicante

location_facility: IRST Istituto Romagnolo Ricerca e Cura dei Tumori

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Klinikum rechts der Isar der TU Munchen II

location_facility: Medical Oncology department /Mansoura University Hospitals

location_facility: National Liver Institute / Menoufyia University

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Szegedi Tudományegyetem Onkoterápiás Klinika

location_facility: National hepatology and tropical medicine research institute

location_facility: Hospital General Universario Gregorio Maranon

location_facility: Ausl 12 Livorno Ospedale Unico della Versilia

location_facility: Semmelweis Egyetem Radiológiai és Onkoterápiás Klinika

location_facility: Medical Oncology department /Ain Shams University Hospitals

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Oncology Department, Medical Research Institute, Alexandria University

location_facility: Clinical Research Center/ Alexandria university hospital

location_facility: Irccs Centro Di Riferimento Oncologico (Cro)


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, Laloë 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.

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.

ReferenceCitation: Liu N, Le Guen M, Boichut N, Genty A, Hérail 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.

lead_sponsor: Hopital Foch

location_country: Germany France Belgium

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

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

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

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

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

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.

lead_sponsor: Hopital Antoine Beclere

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