title: Study of Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma

acronym: AMPULLOMA

summary: A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive tumours. The only curative treatment is complete excision (surgical or endoscopic) of the lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference radical treatment is cephalic duodenopancreatectomy (CDP). The indication for adjuvant treatment is still debated: in view of the aggressive nature of the disease and the high recurrence rate, it would appear appropriate to offer adjuvant treatment, although several studies have failed to find any benefit on survival with post-operative radio-chemotherapy, the most widely studied treatment at present, compared to excision alone. At present there are no phase II studies specifically examining medical treatment of degenerated, inoperable Vater's ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours, although neither one has been shown to date to be superior to the other, nor have decision-making criteria been clearly established.In conclusion, a national cohort study is proposed to undertake a prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). The treatment methods will be left to the free choice of the investigator and all patients may be included, regardless of stage of their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will be supplemented by a later biological study. In order to recruit sufficient patient numbers, the study will be based on participation of the cooperative groups involved in the management of digestive cancers.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Hopital Europeen Georges Pompidou
Chu Cochin
Chu La Pitie Salpetriere
Ch Cornouaille
Hopital de La Timone
Hopital Saint Joseph
Hcl Edouard Herriot
Chu Claude Huriez
Hcl Pierre Benite
Chu Caremeau
Ch Cote Basque
Le Kremlin Bicetre
Ch Nord Essonne
Ch - Sud Francilien
Chu La Croix Rousse
Ch D'Abbeville
CLINIQUE
CHU Hôpital de la Milétrie
Ch Bretagne Atlantique
Polyclinique Bordeaux Nord Aquitaine
Chu Francois Mitterrand
Hopitaux Civils de Colmar
Ch de Meaux
Clinique Champeau
Chd Vendee
Ch Saint Malo
CH MACON
Chu Estaing
Chu Saint Andre
Ch Annecy Genevois
Ch Saint Jean
Chu Avicenne
CH
Chu Hotel Dieu
Hôpital Dupuytren
Chr Orleans


design_allocation: Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

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

lead_sponsor: UNICANCER

enrollment_type: Anticipated

primary_purpose: Treatment

acronym: ALBAN

location_facility: Centre Hospitalier Universitaire Bordeaux

location_facility: Centre Hospitalier Universitaire Marseille

location_facility: Centre Hospitalier Universitaire Lyon Sud

location_facility: Hôpital privé Toulon - Sainte Marguerite

ipd_sharing: No

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: An Open Label, Randomized, Phase III Trial, Evaluating Efficacy of Atezolizumab in Addition to One Year BCG (Bacillus CaLmette-Guerin) Bladder Instillation in BCG-naive Patients With High-risk Non-muscle Invasive Bladder cANcer

summary:
This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease.

The objective is to evaluate the efficacy of atezolizumab as measured by recurrence-free survival.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Efficacy of Regorafenib as Maintenance Therapy in Non-adipocytic Soft Tissue Sarcoma Having Received First-line Doxorubicin-based Chemotherapy

summary: Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy.

lead_sponsor: Centre Oscar Lambret

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut régional du Cancer de Montpellier


title: Preemptive Therapy With Venetoclax for High Risk Chronic Lymphoid Leukemia Stage A Patients, a Phase II Trial of the FILO

summary: Open label, single arm, multicenter phase II trial.

ipd_sharing_description: eCRF

lead_sponsor: French Innovative Leukemia Organisation

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: Centre Hospitalier Regional Metz Thionville


title: A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort

acronym: HAMA

summary: This registry aims to provide the first prospective, multicentric database of patients with malignant hypertension. It will allow to assess modern epidemiology of the disease, diversity of current management and care pathway, to deepen our pathophysiological knowledges, to modernize the definition of this form of hypertension and its diagnostic criteria. The network that will emerge will finally lead to the opportunity of setting up therapeutic trials and establishing recommendations based on solid scientific evidence.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier de PAU

location_facility:
CH de St Nazaire
CH de PAU
CH Métropole
CHU de Strasbourg
Clinique Vert Coteau
CHU de Tours
CH de Dinard
CHU de Rennes
Avicenne APHP
CHU - Hôpital St André
CHU - Hôpital Laennec
CHU de Toulouse Rangueil
CHU de Poitiers
CHU Michallon
CHU de St Etienne
Hôpital Saint Joseph
CH de la côte Basque
Clinique sainte Clotilde
APHP Bichat
CH Martigues
CHRU de Lille
Hôpital Européen Georges Pompidou
hôpital de Haguenau

lead_sponsor_type: academique


title: Multicenter Double Blind Randomized Phase II Trial of Olaparib vs Placebo as Maintenance Therapy in Platinum-sensitive Advanced Endometrial Carcinoma

acronym: UTOLA

summary: This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer

status: Active, not recruiting

enrollment_type: Actual

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Institut Daniel Hollard - GHM de Grenoble

location_facility: Institut Curie - Hopital Claudius Régaud


title: A Single-arm Phase II Multicenter Study of IDH2 (AG-221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome

summary: patients with MDS (Myelodysplastic Syndrome) and mutated IDH2 patients will be treated with AG221 (IDH2 inhibitor)

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: CH Le Mans/Service d'hématologie Oncologie

location_facility: Centre Henri Becquerel/Département d'Hématologie

location_facility: Institut de cancérologie Lucien Neuwirth Saint priest en Jarez

location_facility: Institut Paoli Calmettes/Unité d'Hématologie 3

location_facility: Hôpital Saint Louis - Service d'hématologie séniors

location_facility: CHU Nantes - Hôtel Dieu/Service d'Hématologie Clinique

location_facility: CH d'Angers/Service des Maladies du sang

location_facility: CHU Côte de Nacre/Service d'Hématologie Clinique

location_facility: Hôpital Archet 1/Service d'Hématologie Clinique


title: National Observational Study of the Thoraflex™ Hybrid Vascular Prosthesis in the Replacement of the Aortic Arch and the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta

summary: The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation to morbidity-mortality, visceral malperfusions, neurological and renal complications, endoleak and evolution of the aortic thoracic stent over time.

ReferenceType: background

ReferenceCitation: Arko FR, Lee WA, Hill BB, Olcott C 4th, Harris EJ, Dalman RL, Fogarty TJ, Zarins CK. Impact of endovascular repair on open aortic aneurysm surgical training. J Vasc Surg. 2001 Nov;34(5):885-91.

ReferenceCitation: Karck M, Chavan A, Hagl C, Friedrich H, Galanski M, Haverich A. The frozen elephant trunk technique: a new treatment for thoracic aortic aneurysms. J Thorac Cardiovasc Surg. 2003 Jun;125(6):1550-3.

ReferenceCitation: Usui A, Ueda Y, Watanabe T, Kawaguchi O, Ohara Y, Takagi Y, Tajima K, Nishikimi N, Ishiguchi T. Clinical results of implantation of an endovascular covered stent-graft via midsternotomy for distal aortic arch aneurysm. Cardiovasc Surg. 2000 Dec;8(7):545-9.

ReferenceCitation: Karck M, Kamiya H. Progress of the treatment for extended aortic aneurysms; is the frozen elephant trunk technique the next standard in the treatment of complex aortic disease including the arch? Eur J Cardiothorac Surg. 2008 Jun;33(6):1007-13. doi: 10.1016/j.ejcts.2008.02.030. Epub 2008 Apr 10. Review.

ReferenceCitation: Shrestha M, Pichlmaier M, Martens A, Hagl C, Khaladj N, Haverich A. Total aortic arch replacement with a novel four-branched frozen elephant trunk graft: first-in-man results. Eur J Cardiothorac Surg. 2013 Feb;43(2):406-10. doi: 10.1093/ejcts/ezs296. Epub 2012 May 31.

ReferenceCitation: Patel AY, Eagle KA, Vaishnava P. Acute type B aortic dissection: insights from the International Registry of Acute Aortic Dissection. Ann Cardiothorac Surg. 2014 Jul;3(4):368-74. doi: 10.3978/j.issn.2225-319X.2014.07.06. Review.

ReferenceCitation: Tsai TT, Trimarchi S, Nienaber CA. Acute aortic dissection: perspectives from the International Registry of Acute Aortic Dissection (IRAD). Eur J Vasc Endovasc Surg. 2009 Feb;37(2):149-59. doi: 10.1016/j.ejvs.2008.11.032. Epub 2008 Dec 20.

ReferenceCitation: Jakob H, Tsagakis K. International E-vita open registry. Ann Cardiothorac Surg. 2013 May;2(3):296-9. doi: 10.3978/j.issn.2225-319X.2013.03.10.

ReferenceType: result

ReferenceCitation: Bortone AS, Schena S, D'Agostino D, Dialetto G, Paradiso V, Mannatrizio G, Fiore T, Cotrufo M, de Luca Tupputi Schinosa L. Immediate versus delayed endovascular treatment of post-traumatic aortic pseudoaneurysms and type B dissections: retrospective analysis and premises to the upcoming European trial. Circulation. 2002 Sep 24;106(12 Suppl 1):I234-40.

lead_sponsor: Vascutek Ltd.

location_facility: Centre Hospitalier University (University Hospital centre)

location_facility: Hopitaux Universitaires - Nouvel Hopital Civil

location_facility: Hôpital Rangueil, Cardiothoracic Surgery Department

location_facility: Groupe Hospitalier Pitié-Salpêtrière, Vascular Surgery Department

intervention_type: Device


title: A Phase II Pilot Study to Evaluate the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia With p53 Dysfunction. IDA53 Trial

summary:
Ibrutinib, a first-in-class Bruton Tyrosine kinase (BTK) inhibitor, has become an established treatment in relapsed/refractory chronic lymphocytic leukemia (CLL). However, despite a considerable improvement of Progression Free Survival (PFS) and Overall Survival (OS) in comparison with historical controls, the prognosis of patients with 17p deletion (del17p) remains a concern, as it is clearly much less favourable than that of patient without del17p. Again, TP53 mutations correlated to poorer prognostic in Relapsed/Refractory (R/R) CLL patients treated with ibrutinib (Brown JR et al,2018). Despite these therapeutic advances, the treatment of CLL with TP53 disruption thus remains a difficult issue that warrants evaluation of alternative treatment strategies, in particular the use of ibrutinib in combination with other agents. A body of evidence suggests that targeting the extracellular molecule CD38 might be an interesting option. CD38 is a transmembrane glycoprotein with multiple receptor and enzymatic functions. The interaction of CD38 with its ligand CD31 (also known as Platelet Endothelial Cell Adhesion Molecule (PECAM-1)) not only plays a role in the binding and the migration of leucocytes through the endothelial cells wall but also triggers the activation of intracellular pathways involved in the differentiation and activation of B cells. Previous results strongly suggest that CD38 favours the expansion of CLL clones not only directly by transducing a proliferation signal but also by directing them to anatomic sites where they find favourable conditions for proliferation and survival.

Daratumumab is a first-in-class human IgG1ĸ monoclonal antibody (mAb) that binds CD38-expressing malignant cells with high affinity. Daratumumab induces tumor cell death through multiple mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC), complement dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP) and induction of apoptosis (de Weers et al, 2011). Recent data show that daratumumab may also display an immunomodulatory effect through depletion of a subset of immunosuppressive CD38+ Tregs (Krejcik et al, 2016). Early-stage clinical trials found daratumumab to be safe and to display encouraging clinical activity as a single agent in relapsed/refractory multiple myeloma (MM) patients (Lockhorst et al 2016, Lonial et al, 2016). Overall response rate was 31%, with rapid (median 1 month) and durable responses in this heavily pretreated MM population. Interestingly, no patient discontinued the treatment because of drug-related adverse events. These results led to approval of daratumumab in relapsed/refractory MM in December 2015. The clinical efficacy of daratumumab along with its very favourable safety profile supports its investigation in other lymphoproliferative malignancies. In particular, the expression of CD38 in poor prognosis CLL and the key role of CD38 in CLL biology provide a basis for examining the potential of daratumumab in this disease.

In preclinical studies, (Matas-Céspedes et al, 2016; Manna et al, 2017) Daratumumab efficiently kills CLL cell lines and patient-derived CLL cells by ADCC and ADCP in vitro. Daratumumab modulates CLL-T reg levels and increase cytotoxic effector T cells.

Rationale for combining ibrutinib with daratumumab:

These data suggest that combining ibrutinib with daratumumab might have a synergistic or additive effect. Both drugs inhibit B cell receptor (BCR) signalling via two different converging pathways, i.e. BTK and CD38/ZAP70/ERK (Deaglio et al, 2007). In vitro, Manna et al have shown that daratumumab is able to modulate BCR signaling.

Interestingly, the ibrutinib /daratumumab combination significantly enhanced mitochondrial-mediated apoptosis bth in CD38 high and CD38 low CLL cells (Manna et al, 2017).

Altogether, this provides a rationale for evaluating the safety and efficacy of the association of daratumumab with ibrutinib in high-risk relapsed/refractory patients for whom the standard-of-care using ibrutinib as a single agent has demonstrated limitations in terms of long-term disease control.

Primary objective of the study: to determine the efficacy of a treatment combining daratumumab and ibrutinib in a poor risk population of relapsed CLL patients with TP53 dysfunction.

Secondary objectives of the study : to determine the safety profile of daratumumab in combination with ibrutinib in CLL patients.

Inclusion period: 24 months Treatment duration (ibrutinib + daratumumab): continuous, until disease progression or unacceptable toxicity.

Follow-up period: will begin once the subject discontinues study treatment, during 2 years.

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: CHLS - Lyon Pierre Bénite - Service Hématologie

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: CHU Bordeaux - Hôpital Haut-Lévèque - CFM Maladies du sang

location_facility: Institut Paoli-Calmettes - Hématologie Clinique

location_facility: Hôpitaux de Brabois - Hématologie Adulte

location_facility: Hôpital Robert Debré - Hématologie Clinique

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Hôpital Avicenne - Centre de Recherche Clinique

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

location_facility: Hôpital Saint-Eloi - Hématologie Clinique


title: Efficacy of Treatment Sequences in Patients With ALK and ROS-1 Positive Non-small Cell Lung Cancer Who Received Lorlatinib as Part of the French Expanded Access Program

acronym: LORLATU

summary: The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the French expanded access program.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Saint-Nazaire - Clinique Mutualiste de l'Estuaire

status_simplified: Completed


title: Multicenter Prospective Single Arm Phase II Study Evaluating Efficacy & Safety of Durvalumab With Carboplatin/Paclitaxel as First Line Treatment in Patients With Recurrent/Metastatic SCCHN Not Eligible to Standard Chemotherapy

acronym: FRAIL-IMMUNE

summary: The primary objective of the phase II trial is to determine the efficacy and safety of a combination of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy.

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin


intervention_type: Combination Product

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

acronym: REGIRI

location_facility: Institut de Cancérologie de l'Ouest-René Gauducheau

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

location_facility: Centre de Cancérologie du Grand Montpellier

title: A Randomised Phase 2 Trial Assessing REGorafenib Combined With IRInotecan as Second-line Treatment in Patients With Metastatic Gastro-oesophageal Adenocarcinomas

summary: Trial evaluating the efficacy of regorafenib combined with irinotecan compared to irinotecan alone in second-line treatment of patients with metastatic gastro-oesophageal adenocarcinomas.


type: Other Identifier

title: CHARACTERISTICS OF ADULT PATIENTS TREATED WITH CRIZOTINIB FOR ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) WITH ALK GENE REARRANGEMENT OR ROS1 GENE REARRANGEMENT IN GENERAL HOSPITALS.

summary:
Descriptive Observational Study.

Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: Centre Hospitalier de Troyes, Service de Pneumologie - Oncologie Thoracique

location_facility: Centre Hospitalier de l'Agglomeration de Nevers

location_facility: Centre Hospitalier General Beziers, Service De Pneumologie

location_facility: Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie

location_facility: Centre Hospitalier Chalon sur Saone William Morey

location_facility: Hopitaux Civils de Colmar - Hopital Louis Pasteur

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Centre Hospitalier des Deux Vallees - Longjumeau BP 125

location_facility: Hopital Robert Ballanger, Service de Pneumologie

location_facility: Centre Hospitalier de Villefranche sur Saone - BP80436

location_facility: Hopital Europeen - Service de Pneumologie

location_facility: Centre Hospitalier Metropole de Savoie-Site de Chambery


title: Durvalumab Plus Tremelimumab Combination Immunotherapy With or Without Weekly Paclitaxel in Patients With Advanced Biliary Tract Carcinoma (BTC) After Failure of Platinum-based Chemotherapy: a Randomized Non-comparative Two-arm Phase II Study

acronym: IMMUNO-BIL

summary:
IMMUNO-BIL is a non-comparative randomized 1:1 phase II study. This study will assess the efficacy and safety of the combination of durvalumab plus tremelimumab with or without weekly paclitaxel in patients with advanced BTC after failure of platinum-based chemotherapy.

On the 25th June 2019, the maximum DLT event number was reached (6/10) in the durvalumab plus tremelimumab combination with paclitaxel Arm (Arm B). According to the Pocock boundary described in the protocol, GERCOR has updated the study to discontinue enrollment in Arm B (durvalumab plus tremelimumab with paclitaxel) . No safety concerns were raised by the IDMC in Arm A. Consequently, the study will resume with Arm A (durvalumab plus tremelimumab) only, without randomization.

Discontinuation of ARM B(June 2019): Durvalumab plus tremelimumab plus paclitaxel

One cycle equals 4 weeks (D1=D28); Durvalumab: 1,500 mg by IV infusion on D1, until progression or unacceptable toxicity or withdrawal of consent.

Tremelimumab: 75 mg by IV infusion on D1 for the first 4 cycles. Paclitaxel: 80 mg/m2, every week for 3 weeks (D1-D8-D15), by IV infusion, until progression or unacceptable toxicity or withdrawal of consent (at least 6 cycles, at the discretion of the investigator).

December 2020: Tremelimumab dosage modification based on the results of the Study 22 study (Kelley RK, et al. ASCO20 Virtual Scientific Program 2020) showing increased efficacy (response rate and progression-free survival) without safety concerns with one dose of tremelimumab 300 mg (cycle 1) instead of four doses of 75 mg (cycle 1 to cycle 4) in combination with durvalumab 1,500 mg Q4W in hepatocellular carcinoma. Following these results, we have changed the tremelimumab 75 mg x 4 schedule for the 300 mg x 1 schedule. The inclusion of 106 additional patients will be required to adequately evaluate the efficacy of this administration schedule.

ARM A : Durvalumab plus tremelimumab ( patients included before 31/12/2020) One cycle equals 4 weeks (D1=D28);

Durvalumab: 1,500 mg by IV infusion on D1, until progression or unacceptable toxicity or withdrawal of consent.

Tremelimumab: 75 mg by IV infusion on D1 for the first 4 cycles.

ReferenceType: derived

ReferenceCitation: Boilève A, Hilmi M, Gougis P, Cohen R, Rousseau B, Blanc JF, Ben Abdelghani M, Castanié H, Dahan L, Tougeron D, Metges JP, Tournigand C, Garcia-Larnicol ML, Vernerey D, Turpin A, Neuzillet C. Triplet combination of durvalumab, tremelimumab, and paclitaxel in biliary tract carcinomas: Safety run-in results of the randomized IMMUNOBIL PRODIGE 57 phase II trial. Eur J Cancer. 2021 Jan;143:55-63. doi: 10.1016/j.ejca.2020.10.027. Epub 2020 Dec 3.

family: Boilève

full_name: Alice Boilève

given: Alice

sequence: first

family: Hilmi

full_name: Marc Hilmi

given: Marc

sequence: additional

family: Gougis

full_name: Paul Gougis

given: Paul

family: Cohen

full_name: Romain Cohen

given: Romain

family: Rousseau

full_name: Benoît Rousseau

given: Benoît

family: Blanc

full_name: Jean-Frédéric Blanc

given: Jean-Frédéric

family: Ben Abdelghani

full_name: Meher Ben Abdelghani

given: Meher

family: Castanié

full_name: Hélène Castanié

given: Hélène

family: Dahan

full_name: Laëtitia Dahan

given: Laëtitia

family: Tougeron

full_name: David Tougeron

given: David

family: Metges

full_name: Jean-Philippe Metges

given: Jean-Philippe

family: Tournigand

full_name: Christophe Tournigand

given: Christophe

family: Garcia-Larnicol

full_name: Marie-Line Garcia-Larnicol

given: Marie-Line

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

family: Turpin

full_name: Anthony Turpin

given: Anthony

family: Neuzillet

full_name: Cindy Neuzillet

given: Cindy

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
CHI Poissy Saint Germain
CHU Poitiers
Insitut Gustave Roussy
Institut Hospitalier franco-Britannique
Institut Curie
Hôpital Haut Lévêque
Hôpital Beaujon
CHRU Lille
Hôpital la Timone
Hôpital Saint Antoine
CHRU Jean Minjoz
CHU Dijon
Hôpital Privé Jean Mermoz
Hôpital Prive du confluent SAS
Polyclinique Bordeaux Nord Aquitaine
Hôpital Saint Eloi
Centre Eugène Marquis
CHU Henri Mondor
Institut Andrée Dutreix
CHU Robert Debré
Centre Paul Strauss
Hôpital Cochin
Institut Mutualiste Montsouris
Centre Léon Bérard
Centre Georges François Leclerc
Hôpital Duchenne
CHU Morvan
CHPSO Site de Creil


title: Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression

acronym: ACOUSTIM

summary: Treatment resistant depression (TRD) is a frequent, debilitating condition mostly treated by antidepressants. Repeated magnetic transcranial stimulation (rTMS) has proven adjuvant efficacy in TRD in the acute phase of treatment with a very good tolerance and acceptability. Maintenance rTMS (mTMS) is a strategy consisting in adding regular single TMS sessions after response to an acute course in order to keep the benefit of initial treatment over several month or years. Demonstrating that rTMS is efficient to improve long-term prognosis and decrease economic burden would have a tremendous impact in clinical practice in psychiatry. Thus the investigator's aim is to analyze the long term impact of mTMS treatment on costs, but also quality of life and clinical issues.

primary_purpose: Other

ReferenceCitation: Bulteau S, Laurin A, Volteau C, Dert C, Lagalice L, Schirr-Bonnans S, Bukowski N, Guitteny M, Simons L, Cabelguen C, Pichot A, Tessier F, Bonnin A, Lepage A; ACOUSTIM Investigators Group; HUGOPSY Network, Vanelle JM, Sauvaget A, Riche VP. Cost-utility analysis of curative and maintenance repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant unipolar depression: a randomized controlled trial protocol. Trials. 2020 Apr 5;21(1):312. doi: 10.1186/s13063-020-04255-9.

family: Bulteau

full_name: Samuel Bulteau

given: Samuel

family: Laurin

full_name: Andrew Laurin

given: Andrew

family: Volteau

full_name: Christelle Volteau

given: Christelle

family: Dert

full_name: Cécile Dert

given: Cécile

family: Lagalice

full_name: Lydie Lagalice

given: Lydie

family: Schirr-Bonnans

full_name: Solène Schirr-Bonnans

given: Solène

family: Bukowski

full_name: Nicolas Bukowski

given: Nicolas

family: Guitteny

full_name: Marie Guitteny

given: Marie

family: Simons

full_name: Luc Simons

given: Luc

family: Cabelguen

full_name: Clémence Cabelguen

given: Clémence

family: Pichot

full_name: Anne Pichot

given: Anne

family: Tessier

full_name: Fabienne Tessier

given: Fabienne

family: Bonnin

full_name: Annabelle Bonnin

given: Annabelle

family: Lepage

full_name: Adeline Lepage

given: Adeline

family: Vanelle

full_name: Jean-Marie Vanelle

given: Jean-Marie

family: Sauvaget

full_name: Anne Sauvaget

family: Riche

full_name: Valery-Pierre Riche

given: Valery-Pierre

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

location_facility: Centre hospitalier Guillaume Regnier Rennes


title: Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum

acronym: EVA (ECE)

summary: Women report inappropriate health professional behaviour towards them during pregnancy or childbirth on social networks. However, to date, no data are available to estimate the number of women concerned. These data are necessary to characterize these behaviours to get out of this polemic and build a reflection on the improvement of the patient relationship and the emotional security of women.

lead_sponsor: Hospices Civils de Lyon

location_facility: Réseau AURORE, service de gynécologie Obstétrique, Hôpital de la Croix-Rousse

location_facility: Polyclinique Lyon Nord Service Maternité (NATECIA)

location_facility: Hôpital Privé Drôme Ardèche Clinique Pasteur

location_facility: CH de BOURG EN BRESSE - Pôle Mère Enfant

location_facility: Centre Hospitalier de Sainte Foy les Lyon

location_facility: Centre Hospitalier de Villefranche Sur Saône Hôpital Nord-Ouest

intervention_type: Other


lead_sponsor: Rennes University Hospital

acronym: EFFICACI

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Assistance Publique des Hôpitaux de Paris - Hôpital Henri Mondor

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire d'Amiens-Picardie

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Assistance Publique des Hôpitaux de Paris - Hôpital Beaujon

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Assistance Publique des Hôpitaux de Paris - Hôpital Saint-Louis

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Nancy

title: EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical Trial

summary:
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that results from immune dysregulation. Arguably, the development of Tumor Necrosis Factor (TNF) antagonists (including infliximab, adalimumab and golimumab) revolutionized the management of immune-mediated chronic diseases in the past two decades.

However, about one third of patients will not respond to a first anti-TNF treatment and 10% to 30% will loose response to anti-TNF during the follow-up.

Historically, a switch between anti-TNF was performed to recapture remission and response to anti-TNF. Recently, a new biologic therapy blocking another target has been approved and is now reimbursed during ulcerative colitis, namely vedolizumab. Vedolizumab is an anti-integrin agent avoiding the recruitment of lymphocytes specifically in inflamed gut tissue.

Emerging data suggest that a switch of therapeutic class (meaning a change of biologic target with Non-TNF-targeted biologic) in case of clinical failure or insufficient response to anti-TNF may be the best choice. This idea of a switch out of the anti-TNF class is also supported by data on drug monitoring that may help physician decision making in case of loss of response. However, no trial is currently available and ongoing to assess the best therapeutic strategy. The aim of the proposed study is to assess the best biological based strategy in patient losing response to a first subcutaneous anti-TNF (golimumab and/or adalimumab).


title: Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma

acronym: StrateGlio

summary: Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d'Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.

location_facility:
Centre Léon Bérard
Centre François Baclesse
CHU Grenoble Alpes
CHRU Nancy
Hôpitaux Civils de Colmar
CHU de Limoges
ICO Centre Paul Papin
Centre Jean Perrin
Centre Georges François Leclerc
Centre Paul Strauss
CHU La Timone
Institut Cancérologie Loire
ICM Val d'Aurelle
CHU de Nice - Hôpital de Cimiez
ICO Centre René Gauducheau
CH René Dubos
APHP La Pitié Salpêtrière
Centre Hospitalier d'Amiens
CHRU Tours


title: A Multicentric Randomized Phase II/III Evaluating TSR-042 (Anti-PD-1 mAb) in Combination With Niraparib (Parpi) Versus Niraparib Alone Compared to Chemotherapy in the Treatment of Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After at Least One Line of Chemotherapy

acronym: ROCSAN

summary: Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) < 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is <20%, progression-free survival (PFS) <4 months, and OS <1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.

ipd_sharing_description: No sharing plan

location_facility: Hopital Milétrie - Centre Hospitalier Universitaire Poitiers

location_facility: Centre Régional de Lutte contre le cancer - Institut Bergonié

location_facility: Institut Régional du Cancer de Montpellier (ICM Val d'Aurelle)

location_facility: Groupe Hospitalier des Diaconesses Croix Saint-Simon


ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

name:
Laboratory of Experimental Oncology, Pharmacogenomics and Pharmacogenetics Research Unit, IRCCS Istituto Ortopedico Rizzoli,
      Bologna, Italy

family: Hattinger

full_name: Claudia Maria Hattinger

given: Claudia Maria

family: Patrizio

full_name: Maria Pia Patrizio

given: Maria Pia

family: Magagnoli

full_name: Federica Magagnoli

given: Federica

family: Luppi

full_name: Silvia Luppi

given: Silvia

family: Serra

full_name: Massimo Serra

given: Massimo

journal_name: Expert Opinion on Emerging Drugs

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Brard C, Piperno-Neumann S, Delaye J, Brugières L, Hampson LV, Le Teuff G, Le Deley MC, Gaspar N. Sarcome-13/OS2016 trial protocol: a multicentre, randomised, open-label, phase II trial of mifamurtide combined with postoperative chemotherapy for patients with newly diagnosed high-risk osteosarcoma. BMJ Open. 2019 May 19;9(5):e025877. doi: 10.1136/bmjopen-2018-025877.

family: Brard

full_name: Caroline Brard

given: Caroline

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

given: Sophie

family: Delaye

full_name: Jessy Delaye

given: Jessy

family: Brugières

full_name: Laurence Brugières

given: Laurence

family: Hampson

full_name: Lisa V Hampson

given: Lisa V

family: Le Teuff

full_name: Gwénaël Le Teuff

given: Gwénaël

family: Le Deley

full_name: Marie-Cécile Le Deley

given: Marie-Cécile

family: Gaspar

full_name: Nathalie Gaspar

given: Nathalie

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing_description: Individual participant data will not be shared at an individual level, they will be part of the study database including all enrolled patients.

location_facility: Institut de Cancérologie de Lorraine - Service d'oncologie médicale

location_facility: CHRU de Nancy - Onco-hématologie pédiatrique

location_facility: Hôpital de Hautepierre - Onco-hématologie adulte

location_facility: Institut Curie - Service d'oncologie pédiatrique

location_facility: Institut Curie - Service d'oncologie médicale

location_facility: CHU de Nantes - Service d'oncologie hématologie pédiatrique

location_facility: Hôpital Charles Nicolle - Hémato-Immuno-Oncologie Pédiatrique

location_facility: Centre Léon Bérard - Service d'oncologie médicale

location_facility: Hôpital de la Timone - Service d'oncologie pédiatrique

location_facility: Institut Gustave Roussy - Service d'oncologie médicale

location_facility: Institut régional du Cancer de Montpellier - Service d'oncologie médicale

location_facility: Institut Claudius Regaud - service d'oncologie médicale

location_facility: CHU Bretonneau - Service d'oncologie médicale

location_facility: CHU Amiens-Picardie - Service d'oncologie hématologie pédiatrique

location_facility: Hôpital Armand Trousseau - Service d'hématologie et d'oncologie pédiatrique

location_facility: Hôpital Clocheville - Hématologie et oncologie pédiatrique

location_facility: CHU d'Angers - Service d'oncologie pédiatrique

location_facility: Hôpital de la Timone - service d'oncologie médicale

location_facility: Institut Gustave Roussy - Service de cancérologie de l'enfant et de l'adolescent

location_facility: CHU Arnaud de Villeneuve - Onco-hématologie pédiatrique

location_facility: CHU de Nice - Service d'oncologie hématologie pédiatrique

location_facility: Hôpital Hautepierre - Onco-hématologie pédiatrique

location_facility: Institut Bergonié - Service d'oncologie médicale

location_facility: CHU de Grenoble - Service d'oncologie hématologie pédiatrique

location_facility: CHU de Caen - Service d'oncologie hématologie pédiatrique

location_facility: Centre Eugène Marquis - Service d'oncologie médicale

location_facility: CHU Toulouse - Hôpital des Enfants - Service d'Hémato-Immuno-Oncologie

location_facility: Institut de Cancérologie de l'Ouest (Site René Gauducheau) - Service d'oncologie médicale

location_facility: Centre Oscar Lambret - Unité d'onco-pédiatrie

title: Multicentre, Randomised, Phase 2 Trial of Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (Metastatic Osteosarcoma at Diagnosis or Localised Disease With Poor Histological Response)

summary: Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response).


title: Impact of 2 Transfusion Strategies on the Quality of Life of Multi-transfused Patients With Low Risk Myelodysplastic Syndrome: Multicenter Randomized Trial Comparing a Liberal vs. Restrictive Transfusion Regimen

acronym: SMD-transfu

summary:
Myelodysplastic syndromes (MDS) are heterogeneous malignant bone marrow disorders characterized by ineffective haematopoiesis, peripheral blood cytopenias and variable risk of leukaemia transformation.

Anemia is the most common manifestation of bone marrow failure in MDS. After failure with first-line treatment by Erythropoietin, patients survive in average 5 years under long term blood transfusion. Modalities of blood transfusion are not clearly defined.

Then, the objective of this randomized comparative multicentric study is to compare two modalities of threshold for transfusion:

Restrictive group: Hb < 80g/L and Hb maintain between 80 and 100g/L
Liberal group: Hb < 100g/L and Hb maintain between 100 and 120g/L

primary_purpose: Prevention

lead_sponsor: Lille Catholic University

location_facility:
Saint-Louis Hospital, APHP
Besançon CHU
Limoges CHRU
Cote de Nacre CHU
Amiens CHU
Bordeaux CHU
Clermont-Ferrand CHU
Henri Duffaut CH
Lens CH
Meaux CH
Reims CHU
Pontchaillou Hospital
Abbeville CH
Arras CH
Le Mans CH
Grenoble CHU
St-Vincent Hospital
Archet 1 Hospital


title: Evaluation of Perioperative Eltrombopag for the Management of Elective Surgery and Invasive Acts in Patients With Inherited Thrombocytopenia

acronym: ELPOT

summary: The objective of the study is to estimate the response to eltrombopag based on platelet count increase above a safety level of 80 G/L and lack of requirement for pre-, per- and post-operative administration of platelet concentrates (PC) for performing elective invasive acts at mild or high bleeding risk,in selected patients with inherited thrombocytopenia (IT).

ReferenceCitation: Pecci A, Gresele P, Klersy C, Savoia A, Noris P, Fierro T, Bozzi V, Mezzasoma AM, Melazzini F, Balduini CL. Eltrombopag for the treatment of the inherited thrombocytopenia deriving from MYH9 mutations. Blood. 2010 Dec 23;116(26):5832-7. doi: 10.1182/blood-2010-08-304725. Epub 2010 Sep 15.

ReferenceCitation: Pecci A. Pathogenesis and management of inherited thrombocytopenias: rationale for the use of thrombopoietin-receptor agonists. Int J Hematol. 2013 Jul;98(1):34-47. doi: 10.1007/s12185-013-1351-7. Epub 2013 May 1. Review.

ReferenceCitation: Pecci A, Barozzi S, d'Amico S, Balduini CL. Short-term eltrombopag for surgical preparation of a patient with inherited thrombocytopenia deriving from MYH9 mutation. Thromb Haemost. 2012 Jun;107(6):1188-9. doi: 10.1160/TH12-01-0005. Epub 2012 Mar 8.

ReferenceCitation: Gerrits AJ, Leven EA, Frelinger AL 3rd, Brigstocke SL, Berny-Lang MA, Mitchell WB, Revel-Vilk S, Tamary H, Carmichael SL, Barnard MR, Michelson AD, Bussel JB. Effects of eltrombopag on platelet count and platelet activation in Wiskott-Aldrich syndrome/X-linked thrombocytopenia. Blood. 2015 Sep 10;126(11):1367-78. doi: 10.1182/blood-2014-09-602573. Epub 2015 Jul 29.

ReferenceCitation: Favier R, Feriel J, Favier M, Denoyelle F, Martignetti JA. First successful use of eltrombopag before surgery in a child with MYH9-related thrombocytopenia. Pediatrics. 2013 Sep;132(3):e793-5. doi: 10.1542/peds.2012-3807. Epub 2013 Aug 12.

ReferenceCitation: Fiore M, Saut N, Alessi MC, Viallard JF. Successful use of eltrombopag for surgical preparation in a patient with ANKRD26-related thrombocytopenia. Platelets. 2016 Dec;27(8):828-829. Epub 2016 Jun 8.

ReferenceCitation: Zhang J, Liang Y, Ai Y, Xie J, Li Y, Zheng W. Thrombopoietin-receptor agonists for children with immune thrombocytopenia: a systematic review. Expert Opin Pharmacother. 2017 Oct;18(15):1543-1551. doi: 10.1080/14656566.2017.1373091. Epub 2017 Sep 4. Review.

lead_sponsor: University Hospital, Toulouse

location_facility:
Tours Hospital
Rouen Hospital
Nantes Hospital
Angers Hospital
Hospices Civils Lyon
university hospital Toulouse
Caen Hospital
Nancy Hospital
Bordeaux Hospital
Marseille Hospital
Strasbourg Hospital
Lille Hospital
Robert Debré Hospital
Poitiers Hospital
Bensancon Hospital
Hopital Europeen G Pompidou
Dijon Hospital
Necker Hospital
Clermont-Ferrand Hospital
Reims Hospital
Kremlin Bicetre Hospital
Rennes Hospital
Cochin Hospital
Trousseau Hospital
Montpellier Hospital


title: Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS

acronym: BFR-ESS

summary: The primary objective is to compare the progression-free survival (PFS) between aromatase inhibitors interruption and aromatase inhibitors maintenance strategies in patients with a locally advanced or metastatic Low Grade Endometrial Stromal Sarcoma (LGESS).

location_facility: Groupe Hospitalier Diaconesses - Crois Saint Simon

location_facility: Institut de Cancérologie Lucien Neuwirth


title: A Phase II Study of Dexamethasone Added to Induction and Post-remission Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

summary: Recent preclinical and clinical data strongly suggested that dexamethasone could improve the activity of intensive chemotherapy in AML. In this study, the FILO study group will assess the impact of adding dexamethasone to both induction and consolidation therapy in older AML patients with intermediate or favorable risk.

location_facility: CHU Brest - Hôpital Morvan - Hématologie Clinique

location_facility: Institut Paoli-Calmettes - Hématologie 2

location_facility: CHU Reims - Hôpital Robert Debré - Hématologie Clinique

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie

location_facility: Hôpital Haut Levêque- CFM -Hématologie Clinique Et Thérapie Cellulaire

location_facility: CHU Bretonneau - Centre Henri Kaplan - Hématologie et Thérapie Cellulaire

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

location_facility: Hôpital Saint-Eloi - Hématologie Clinique


title: Impact of a New Sequential Approach on Antimicrobial Use in Young Children With Fever Without Source in Emergency Department

acronym: DIAFEVER

summary: Because a newly available point-of-care test may have real interest especially for children in the Emergency Department (ED) setting, by limiting painful and stressful venipunctures and decreasing the length of stay in the ED, the investigators hypothesize that integrating this new capillary Procalcitonin (PCT) rapid test in the DIAFEVER CPR (Clinical Prediction Rules) could represent a highly valuable diagnostic tool to identify a group with low Invasive Bacterial Infection (IBI) risk and could limit unnecessary exams and antibiotic prescriptions. The aim of this present study is to demonstrate the impact of this new PCT rapid-test-based CPR on antibiotic prescription rate in young children with Fever Without Source (FWS) presenting to the ED and on morbidity and mortality

primary_purpose: Diagnostic

ReferenceCitation: Hubert G, Launay E, Feildel Fournial C, Chauvire-Drouard A, Lorton F, Tavernier E, Giraudeau B, Gras Le Guen C. Assessment of the impact of a new sequential approach to antimicrobial use in young febrile children in the emergency department (DIAFEVERCHILD): a French prospective multicentric controlled, open, cluster-randomised, parallel-group study protocol. BMJ Open. 2020 Aug 13;10(8):e034828. doi: 10.1136/bmjopen-2019-034828.

lead_sponsor: Nantes University Hospital

location_country: France Switzerland

location_facility:
Saint Antoine Saint Vincent Hospital
Hospices civils de Lyon
AP-HP Robert Debré
Hopital des Enfants
Regional University Hospital
AP-HP Antoine Béclère
University Hospital
Saint Brieuc Hospital
AP-HP Necker-Enfants Malades
Chu Saint Etienne
CHD Vendée
CHU
Centre Hospitalier Intercommunal
Southern Bretagne Hospital
Hopital Louis Mourier

intervention_type: Diagnostic Test


lead_sponsor: Hoffmann-La Roche

acronym: PRO-MSACTIVE

location_facility: Hôpital General - Service de neurologie; Service de neurologie

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Centre hospitalier de Mulhouse Hopital Emile Muller; Neurologie

location_facility: Hôpital Charles Nicolle; Service de Neurologie

location_facility: Centre hospitalier Guy Chatiliez de Tourcoing; Neurologie

location_facility: Centre Hospitalier de Cornouaille; Neurologie

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: Hopital européen de Marseille; Neurologie

location_facility: Centre hospitalier Andre Mignot; Neurologie

location_facility: CHU Saint Etienne - Hôpital Nord; Neurologie

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: Groupe Hospitalier Paris Saint Joseph; Service de Neurologie et Neurovasculaire

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: Centre hospitalier de Libourne Hopital Robert Boulin; Neurologie

location_facility: Centre Hospitalier d'Aix CPHA; Neurologie

location_facility: Fondation Rothschild; Service de Neurologie

location_facility: Fondation Hopital Saint Joseph; Neurologie

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: CHU Angers, Batiement Larrey 2, Neurologie

location_facility: CHU Brest Hopital La Cavale Blanche; Neurologie

location_facility: Centre hospitalier Annecy Genevois Site St Julien; Neurologie

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Centre hospitalier de Valence; Neurologie

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: HIA de Toulon hôpital militaire; Neurologie

location_facility: Hopital Civil de Strasbourg; Service de Neurologie

location_facility: Centre hospitalier de Montlucon; Neurologie

title: An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis

summary: This national, open-label study is designed to give complementary efficacy, safety and patient reported outcomes (PROs) data in participants with active relapsing forms of MS. Participants will receive a maximum of 2 treatment cycles of ocrelizumab infusions: an initial dose of two 300 milligram (mg) infusions separated by 14 days followed by one single infusion of 600 mg ocrelizumab 24 weeks after the first infusion. Disease activity is determined by clinical relapses and/or Magnetic Resonance Imaging (MRI) activity.


title: Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Atherosclerotic Mesenteric Arterial Disease:a Randomised Study.

acronym: ESTIMEC

summary:
Chronic Mesenteric Ischemia (CMI) is defined by one or more arterial digestive lesions, responsible for severe mesenteric symptoms. The clinical presentation of CMI is characterized by postprandial abdominal pain and weight loss, leading to severe malnutrition. It is a frequent pathology which affects preferentially the elderly patients of female sex (70%) with cardio-vascular comorbidities. Risk factors include smoking, hypertension, and dyslipidemia.

Despite medical and diagnostic advances, the morbidity and mortality of CMI remain very high (>70%). Optimal management of CMI is based on early diagnosis. Symptomatic patients with CMI should be treated without much delay to relief symptoms (present in 43% patients) and prevent acute mesenteric ischemia.

The three visceral arteries affected by atherosclerotic disease are coeliac trunc, inferior mesenteric artery and Superior Mesenteric Artery (SMA). The SMA is treated the most frequently, because it is the main relevant artery associated with CMI.

Endovascular treatment (angioplasty and stenting) is considered as the first-line treatment for CMI when feasible. It is indicated especially in the case of high grade stenosis or occlusion of the Superior Mesenteric Artery. Two types of stents can be used for this procedure: bare metal stents (BMS) or covered stents (CS).

Even if BMS are standard care there is no consensus on the type of stent to use.

There are very few reported series with large numbers of patients comparing BMS and CS in this indication. However, to our knowledge, no results from a randomized study addressing this issue have ever been published. These are only retrospective with a low level of evidence (IIb). The largest series compared 147 patients with primary intervention for CMI treatment using BMS versus 42 using CS. Treatment with CS showed better results in terms of symptom recurrence (10% vs 32%, p <0.002), restenosis (12% vs 42%, p <0.0002) and re-interventions (10% vs 42%), after at least 1 year of follow-up. Indeed, endovascular treatment using BMS was associated with high incidence of symptoms recurrence despite the satisfying patency rates in both occluded and stenotic vessels.

There are no international guidelines to recommend the use of one or another sort of stent.

The necessity of a randomised study addressing the issue of bare metal versus covered stents deployment seems to be important.

The investigators propose to demonstrate that covered stents presents a better efficacy than bare metal stents, with a multicenter randomized study involving 24 vascular surgical departments of French University Hospitals.

location_facility: Département de Chirurgie Vasculaire, CHU Clermont-Ferrand - Hôpital G. Montpied

location_facility: Département de Chirurgie Vasculaire, CHU d'Angers

location_facility: Département de Chirurgie Vasculaire, CHU Côte de Nacre Caen

location_facility: Département de Chirurgie Vasculaire, CHRU Hôpital Cardiologique de Lille

location_facility: Département de Chirurgie Vasculaire, CHU Nice - Hôpital Pasteur

location_facility: Hospices Civils de Lyon, Hôpital Edouard Herriot

location_facility: Département de Chirurgie Vasculaire? CHU Nancy - Hôpital Brabois

location_facility: Service de Chirurgie Vasculaire, CHU de Brest, Hôpital de La Cavale Blanche

location_facility: Département de Chirurgie Vasculaire, Centre Hospitalier Saint Philibert, Lomme

location_facility: Département de Chirurgie Vasculaire, CHU Amiens Picardie - Site Sud

location_facility: Département de Chirurgie Vasculaire, CHU Marseille - Hôpital la Timone

location_facility: Service de Chirurgie Vasculaire et Générale, CHU de Bordeaux - Hôpital Pellegrin

location_facility: Département de Chirurgie Vasculaire, APHP Hôpital de la Pitié-Salpêtrière

location_facility: Département de Chirurgie Vasculaire, CHU Poitiers - Hôpital Jean Bernard

location_facility: Département de Chirurgie Cardio-Vasculaire, CHU Le Bocage Dijon Bourgogne

location_facility: Département de Chirurgie Cardio-Vasculaire, CHU Saint Etienne - Hôpital Nord

location_facility: Département de Chirurgie Vasculaire, CHU Pontchailloux Rennes

location_facility: Département de Chirurgie Vasculaire, CHU Toulouse - Hôpital Rangueil

location_facility: Service de Chirurgie Vasculaire, CHU de Strasbourg, Nouvel Hôpital Civil

location_facility: Département de Chirurgie Vasculaire, APHP Hôpital Henri Mondor

location_facility: Département de Chirurgie Vasculaire, CHU de Rouen

location_facility: Département de Chirurgie Vasculaire? CHU J. Minjoz Besançon

location_facility: Département de Chirurgie Vasculaire, APHP Hôpital Ambroise Paré

location_facility: Département de Chirurgie Vasculaire, CHU Nantes - Hôpital Nord Laënnec


title: CHRONO - Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

acronym: CHRONO

summary: The aim of CHRONO trial is to compare the DFS when surgery is performed after 3 courses of NACT, or after 6 courses of NACT, in a prospective multi institutional randomized setting,considering only patients initially unsuitable for primary surgery.

location_facility: Hôpitaux Drôme Nord - Site de Romans-sur-Isère

location_facility: Centre Hospitalier Universitaire de Nantes-Hôpital Mère et Enfant

location_facility: CHU de Limoges - Hôpital de la Mère et de l'Enfant

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire

location_facility: CHU Grenoble-Alpes - Site Nord (La Tronche)

location_facility: Centre Hospitalier Universitaire Bretonneau

location_facility: Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers

intervention_type: Procedure


title: A Non-comparative Randomized 2:1 Phase II Study of Docetaxel, Cisplatin, and 5-fluorouracil in Combination or Not With Atezolizumab in Patients With Metastatic or Unresectable Locally Advanced Squamous Cell Anal Carcinoma

acronym: SCARCE

summary:
SCARCE is a non-comparative randomized, 2:1 phase II study. The purpose of this study is to assess the progression-free survival rate at 12 months. (evaluation according with RECISTv1.1 criteria).

For all patients, CT scan will be planned at baseline, and every 8 weeks until 12 months from randomization (or disease progression), and every 12 weeks thereafter.

PET scan will be performed at baseline, at the end of mDCF treatment, and at 12 months after randomization (in absence of disease progression).

CT scan and PET scan will be collected for a centralized review.

ReferenceCitation: Kim S, Buecher B, André T, Jary M, Bidard FC, Ghiringhelli F, François É, Taieb J, Smith D, de la Fouchardière C, Desramé J, Samalin E, Parzy A, Baba-Hamed N, Bouché O, Tougeron D, Dahan L, El Hajbi F, Jacquin M, Rebucci-Peixoto M, Spehner L, Vendrely V, Vernerey D, Borg C. Atezolizumab plus modified docetaxel-cisplatin-5-fluorouracil (mDCF) regimen versus mDCF in patients with metastatic or unresectable locally advanced recurrent anal squamous cell carcinoma: a randomized, non-comparative phase II SCARCE GERCOR trial. BMC Cancer. 2020 Apr 25;20(1):352. doi: 10.1186/s12885-020-06841-1.

family: Kim

full_name: Stefano Kim

given: Stefano

family: Buecher

full_name: Bruno Buecher

given: Bruno

family: André

full_name: Thierry André

given: Thierry

family: Jary

full_name: Marine Jary

given: Marine

family: Bidard

full_name: François-Clément Bidard

given: François-Clément

family: Ghiringhelli

full_name: François Ghiringhelli

given: François

family: François

full_name: Éric François

given: Éric

family: Taieb

full_name: Julien Taieb

given: Julien

family: Smith

full_name: Denis Smith

given: Denis

family: de la Fouchardière

full_name: Christelle de la Fouchardière

given: Christelle

family: Desramé

full_name: Jérôme Desramé

given: Jérôme

family: Samalin

full_name: Emmanuelle Samalin

given: Emmanuelle

family: Parzy

full_name: Aurélie Parzy

given: Aurélie

family: Baba-Hamed

full_name: Nabil Baba-Hamed

given: Nabil

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Tougeron

full_name: David Tougeron

given: David

family: Dahan

full_name: Laëtitia Dahan

given: Laëtitia

family: El Hajbi

full_name: Farid El Hajbi

given: Farid

family: Jacquin

full_name: Marion Jacquin

given: Marion

family: Rebucci-Peixoto

full_name: Magali Rebucci-Peixoto

given: Magali

family: Spehner

full_name: Laurie Spehner

given: Laurie

family: Vendrely

full_name: Véronique Vendrely

given: Véronique

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

location_facility: Groupe Hospitalier Diaconesses Crois Saint Simon


title: COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity.

acronym: COLISURG

summary: The surgical treatment of the ulcerative colitis (UC) remains associate to a significant morbidity (up to 60%). Anastomotic fistula and pelvic sepsis are the most severe complications which could dramatically compromise the surgical issue and functional status. Thanks to the current therapeutic arsenal and the evolution of health care paradigms, the quality of life of patients plays a key role in the modern global management of these medical conditions. Biotherapies (e.g anti-TNF) are widely used to treat patients with UC. Anti-TNF and anti-integrins have an effect on the immune response and can theoretically aggravate the infectious disease. Their potential impact on postoperative complications after ileo anal anastomosis (AIA) remains debated. Very few studies have looked at other biotherapies including vedolizumab. All studies are retrospective series with small sample size. Here again the conclusion remain contradictory. Lightner et al. showed an increased risk of surgical site infection for patients preoperatively exposed to vedolizumab (37% vs. 10%, p <0.001). In a dedicated cohort to the RCH, the same author found a risk of increased pelvic abscess (31.3% vs 5.9%, NS) but the difference was not statistically significant probably for lack of power. Other studies did not find any impact of vedolizumab on the risk of postoperative complications. To clearly determine within a large prospective cohort the impact of anti-TNF agents and biotherapies on the postoperative complications seems to be essential in order to adapt and to optimize the therapeutic strategy, especially the surgical sequences, in patients with UCR whom benefit a surgery.

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: APHP - Hôpital Européen Georges Pompidou

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Grenoble


title: A Single-arm Phase II Multicenter Study of IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome

summary: patients with MDS (Myelodysplastic Syndrome) and mutated IDH1 patients will be treated with AG120 (IDH1 inhibitor)

location_country: Italy France

location_facility: Hôpital Nord Franche-Comté/Service de médecine interne / Hématologie clinique

location_facility: Hôpital Saint Louis - Hématologie Séniors

location_facility: Centre Hospitalier de Versailles-Hôpital André Mignot

location_facility: CHU de Haut-Lévèque/Centre François Magendie/Service des maladies du sang

location_facility: CHU Hôtel Dieu/Service d'Hématologie Clinique

location_facility: CH Le Mans/Service d'hématologie Oncologie

location_facility: Hôpital Archet 1/Service d'Hématologie Clinique

location_facility: Institut Paoli Calmettes/Unité d'Hématologie 3

location_facility: CHU de Grenoble/Clinique Universitaire d'hématologie 6e A

location_facility: Ematologia ed Immunologia Clinica PADOVA

location_facility: Hôpital E. Muller-GHR Mulhouse Sud-Alsace

location_facility: CHU de Poitiers/Pôle de cancérologie - secteur tertiaire-

location_facility: institut de cancérologie Lucien Neuwirth


title: Molecular and Immunological Characterisation of High Risk CHildhood Cancer At DiagnOsis, Treatment and Follow-up - Biological Evaluation in Children, Adolescents and Young Adults -

acronym: MICCHADO

summary:
Methodology:

Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study

design_allocation: Non-Randomized

lead_sponsor: Institut Curie

location_facility: Centre Régional de Cancérologie et Thrapie Cellulaire Pdiatrique (CRCTCP)

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Hôpital universitaire Robert-Debré (AP-HP)

location_facility: CHU de Bordeaux - Hôpital des enfants - Groupe Hospitalier Pellegrin

location_facility: CHU GRENOBLE Alpes - Hôpital Couple-Enfant


title: Diagnostic Value of Multiparametric MR Imaging of Small Solid Renal Tumors (IRMK01)

summary: Renal cell carcinoma represents annually 3-5% of all new cancer diagnoses. To date, the standard of care for small renal masses is partial nephrectomy. However, in the specific setting of small renal masses, 20% of them are benign and surgery results in overtreatment. Non-invasive techniques able to differentiate the inherent characteristics of tumors (nature, aggressiveness) would be useful to offer the most appropriate therapeutic options. Morphological ultrasound or CT imaging appeared limited because of the lack of discriminatory power. Based on the data of retrospective studies, the hypothesis is that multiparametric (mp) MR parameters using chemical shift, diffusion and/or contrast injection techniques may be a reproducible diagnostic test with sufficient diagnostic accuracy to differentiate benign from malignant renal tumors. The originality of this project lies in the opportunity to simultaneously assess the performance of mpMRI in diagnosing renal tumors in a routine clinical practice in 18 centers. In each center, two independent MRI readings performed by two radiologists will be carried out within a short delay and interpreted blind to each other's results or pathological results using a predefined template. A third reading will also be centrally performed by the coordinating center according to similar modality. All clinical, radiological and pathological data will be collected after anonymization in the UroCCR database. These informations are used to adjust the therapeutic decision and selecting patients eligible for nephrectomy, other therapeutic options or monitoring.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU Angers
APHM - Hôpital de la Conception
CHRU Lille
CHU Strasbourg
CHU Toulouse
APHP - Hôpital Bichat
APHP - Hôpital Necker
APHP - Hôpital Tenon
APHP - Henri Mondor
CHU de Grenoble
CHU Bordeaux
CHU Lyon
CHU Tours
CHU Nice
CHU Rennes
CHU Nancy
CHU Rouen
APHP - Hôpital Bicêtre


acronym: DICIPLE

location_facility:
CH Chambery
Colmar - CH
La Roche Sur Yon - CH
Mont de Marsan - CH
CH Lyon Sud - Pneumologie
Nantes - Centre René Gauducheau
CHRU de Tours
Clermont Ferrand - CHU
CH de Pontoise
Annecy - CH
AP-HP Hôpital Bichat
Paris - Institut Curie
Centre Antoine Lacassagne
ICL Lucien Neuwirth
Cahors - CH
Avignon - CH
CH de Villefranche - Pneumologie
Caen - CHU Côte de Nacre
AP-HP Hopital Tenon - Pneumologie
Dijon - CAC
Angers - CHU
Suresnes - Hopital Foch
Hôpital Saint Louis APHP
Amiens - CHU
CHU Toulouse
Argenteuil -CH
Bordeaux - Polyclinique Nord
GH Paris Saint-Joseph
CHU Nîmes
Rouen - CHU
Clamart - Hôpital Percy
CH de Chauny
Centre René Huguenin
Institut Paoli Calmette
CHRU Grenoble
Saint Quentin - CH
Centre Hospitalier - Pneumologie
Boulogne - Ambroise Paré
Marseille - Hôpital Européen
CH
HIA Begin
CHRU de Lille
CHU de Limoges
Orléans - CH
Versailles - CH
Toulon - CHI
Mulhouse - CH

ipd_sharing: Undecided

title: A Randomized Phase 3 Trial Comparing Continuation Nivolumab-Ipilimumab Doublet Immunotherapy Until Progression Versus Observation in Treatment-naive Patients With PDL1-positive Stage IV Non-Small Cell Lung Cancer (NSCLC) After Nivolumab-Ipilimumab Induction Treatment

summary: Non Small Cell lung cancer (NSCLC) remains the first cause of death by cancer in the World. For the patients presenting a NSCLC stage IV, the median of survival is about 15 months today. The chemotherapy with platinum is the standard treatment for these patients but immunotherapy showed these efficacy in 1st line for patients PD-L1 positive. On the other hand, the duration of treatment by immunotherapy is not clear. Indeed, prolonged responses and long survivals have been described in patients having interrupted the treatment. In the melanoma, a treatment of 6 months of ipilimumab demonstrated its efficacy. The objective of the study is to demonstrate that a treatment of 6 months followed by an observation (stop and go) is not less effective than a treatment given until progression or toxicity. This strategy would allow to decrease the accumulated toxicities, to improve the quality of life of the patients and to decrease the costs.


title: Guided Fluid-balance Optimization With Mini-fluid chALlenge During Septic Shock: A Multicenter, Stepped Wedge Cluster Randomized Trial

acronym: GOAL

summary: Many observational studies have highlighted an independent association between fluid overload and clinical outcomes during septic shock. To optimize fluid balance, clinician has several options to consider carefully fluid administration and avoid fluid overload. More than a general restrictive approach, a pragmatic, individual tailored approach should be considered to optimize patients' hemodynamics during acute circulatory failure. Many advances in hemodynamic monitoring were described. Mini-fluid challenge appears to be a sensible method to use for bedside assessment to optimize fluid infusion. The next step for hemodynamic management in the ICU should be to test a hemodynamic goal-directed approach to better control fluid management and eventually improve patient's outcome. The main objective of the GOAL study is to evaluate a pragmatic optimization fluid management protocol tailored to each patient's hemodynamic status based on mini-fluid challenges. This intervention will be compared to usual management based on the latest guidelines. This intervention aims to decrease organ dysfunction during septic shock. This is the first large clinical trial designed to test this hypothesis.

ReferenceCitation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

name: Bloomsbury Institute of Intensive Care Medicine, University College London, London, United Kingdom

family: Singer

full_name: Mervyn Singer

given: Mervyn

name: Hofstra–Northwell School of Medicine, Feinstein Institute for Medical Research, New Hyde Park, New York

family: Deutschman

full_name: Clifford S. Deutschman

given: Clifford S.

name: Department of Critical Care and Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania

family: Seymour

full_name: Christopher Warren Seymour

given: Christopher Warren

name: Department of Critical Care Medicine, Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom

family: Shankar-Hari

full_name: Manu Shankar-Hari

given: Manu

name: Department of Critical Care Medicine, University of Versailles, France

family: Annane

full_name: Djillali Annane

given: Djillali

name: Center for Sepsis Control and Care, University Hospital, Jena, Germany

family: Bauer

full_name: Michael Bauer

given: Michael

name: Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, and Austin Hospital, Melbourne, Victoria, Australia

family: Bellomo

full_name: Rinaldo Bellomo

given: Rinaldo

name: Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University, Nashville, Tennessee

family: Bernard

full_name: Gordon R. Bernard

given: Gordon R.

name: Réanimation Médicale-Hôpital Cochin, Descartes University, Cochin Institute, Paris, France

family: Chiche

full_name: Jean-Daniel Chiche

given: Jean-Daniel

name: Critical Care Center, Emory University School of Medicine, Atlanta, Georgia

family: Coopersmith

full_name: Craig M. Coopersmith

given: Craig M.

name: Washington University School of Medicine, St Louis, Missouri

family: Hotchkiss

full_name: Richard S. Hotchkiss

given: Richard S.

name: Infectious Disease Section, Division of Pulmonary and Critical Care Medicine, Brown University School of Medicine, Providence, Rhode Island

family: Levy

full_name: Mitchell M. Levy

given: Mitchell M.

name: Department of Surgery, University of Toronto, Toronto, Ontario, Canada

family: Marshall

full_name: John C. Marshall

given: John C.

name: Emory University School of Medicine and Grady Memorial Hospital, Atlanta, Georgia

family: Martin

full_name: Greg S. Martin

given: Greg S.

family: Opal

full_name: Steven M. Opal

given: Steven M.

name: Trauma, Emergency & Critical Care Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada16Interdepartmental Division of Critical Care, University of Toronto

family: Rubenfeld

full_name: Gordon D. Rubenfeld

given: Gordon D.

name: Department of Infectious Diseases, Academisch Medisch Centrum, Amsterdam, the Netherlands

family: van der Poll

full_name: Tom van der Poll

given: Tom

name: Department of Intensive Care, Erasme University Hospital, Brussels, Belgium

family: Vincent

full_name: Jean-Louis Vincent

given: Jean-Louis

name: Department of Critical Care Medicine, University of Pittsburgh and UPMC Health System, Pittsburgh, Pennsylvania20Associate Editor, JAMA

family: Angus

full_name: Derek C. Angus

given: Derek C.

journal_name: JAMA

oa_colors: green hybrid

evidence: open (via free pdf)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery

ReferenceCitation: Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.

ReferenceCitation: Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77.

ReferenceCitation: Malbrain ML, Marik PE, Witters I, Cordemans C, Kirkpatrick AW, Roberts DJ, Van Regenmortel N. Fluid overload, de-resuscitation, and outcomes in critically ill or injured patients: a systematic review with suggestions for clinical practice. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):361-80. doi: 10.5603/AIT.2014.0060. Review.

ReferenceCitation: Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

ReferenceCitation: Sakr Y, Rubatto Birri PN, Kotfis K, Nanchal R, Shah B, Kluge S, Schroeder ME, Marshall JC, Vincent JL; Intensive Care Over Nations Investigators. Higher Fluid Balance Increases the Risk of Death From Sepsis: Results From a Large International Audit. Crit Care Med. 2017 Mar;45(3):386-394. doi: 10.1097/CCM.0000000000002189.

ReferenceCitation: Marik PE, Linde-Zwirble WT, Bittner EA, Sahatjian J, Hansell D. Fluid administration in severe sepsis and septic shock, patterns and outcomes: an analysis of a large national database. Intensive Care Med. 2017 May;43(5):625-632. doi: 10.1007/s00134-016-4675-y. Epub 2017 Jan 27.

ReferenceCitation: Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11. Erratum in: Intensive Care Med. 2015 Sep;41(9):1737-8. multiple investigator names added.

ipd_sharing_description: All collected data that underlie results in a publication

location_facility: George Pompidou university hospital (APHP)

location_facility: Kremlin Bicêtre university hospital (APHP)


title: Diagnostic Accuracy of the ATE Score for the Exclusion of Intra-atrial Thrombi Before Catheter Ablation of Atrial Fibrillation: a Confirmatory Study

acronym: EXTRALUCID

summary:
Atrial fibrillation is the most frequent heart rhythm disorder. Its symptomatic forms, resistant to drug therapy, require invasive management (catheter ablation), which exposes to potentially serious complications including thromboembolic complications. Despite anticoagulant treatment, intra-atrial thrombus, which is a contraindication to catheter ablation, is detected in nearly 2 % of cases. Its diagnosis requires prior transoesophageal echocardiography, an unpleasant examination.

A previous study (NCT02199080) showed that a zero ATE score, defined by no heart failure, no hypertension, no history of stroke, d-dimer < 270 ng/mL, has a negative predictive value of 100 % for the exclusion of intra-atrial thrombus.

The objective of the study is to confirm the negative predictive value, sensitivity and specificity of the ATE score for the exclusion of intra-atrial thrombus.

time_perspective: Cross-Sectional

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

location_country: Italy France Switzerland

location_facility: Service de cardiologie, Centre Cardiologique du Nord

location_facility: Service de cardiologie, Polyclinique Vauban

location_facility: Service de cardiologie, Centre Hospitalier du pays d'Aix

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Service de cardiologie, CHR Metz Thionville

location_facility: Service de cardiologie, Clinique Saint Joseph

location_facility: Città della Salute e della Scienza Hospital

location_facility: Service de cardiologie, CHU Saint Etienne

location_facility: Service de cardiologie, Hôpital privé du Confluent

location_facility: Service de cardiologie, CH Annecy Genevois


title: Effect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor Inhibitors

acronym: SariPRO

summary:
Primary Objective:

To assess the effect of sarilumab in combination with conventional synthetic Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported impact of disease, using the rheumatoid arthritis impact of disease (RAID) questionnaire, in participants with moderately to severely active rheumatoid arthritis (RA) and inadequate response or intolerance to current csDMARD or tumor necrosis factor (TNF) inhibitors.

Secondary Objectives:

To assess the change of the RAID score from baseline (to Week 4, Week 12, and Week 24) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors, treated with sarilumab in combination with csDMARD and/or monotherapy.
To assess the effect of sarilumab in combination with csDMARD and/or monotherapy on other participant-reported outcomes (global assessment of disease activity, disability, morning stiffness, fatigue, anxiety/depression, mood disorders, and physical activities) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
To assess the efficacy of sarilumab in combination with csDMARD and/or monotherapy using disease activity score-28 for RA with erythrocyte sedimentation rate (DAS28-ESR) and clinical disease activity index in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
To assess the safety of sarilumab in combination with csDMARD and/or monotherapy in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to participant level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Participant level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_facility:
Investigational Site Number 250005
Investigational Site Number 250004
Investigational Site Number 250002
Investigational Site Number 250020
Investigational Site Number 250016
Investigational Site Number 250014
Investigational Site Number 250009
Investigational Site Number 250024
Investigational Site Number 250001
Investigational Site Number 250015
Investigational Site Number 250021
Investigational Site Number 250027
Investigational Site Number 250031
Investigational Site Number 250006
Investigational Site Number 250019
Investigational Site Number 250013
Investigational Site Number 250018
Investigational Site Number 250012
Investigational Site Number 250003
Investigational Site Number 250028
Investigational Site Number 250017
Investigational Site Number 250025
Investigational Site Number 250011
Investigational Site Number 250008
Investigational Site Number 250034
Investigational Site Number 250010
Investigational Site Number 250029
Investigational Site Number 250023
Investigational Site Number 250022
Investigational Site Number 250026
Investigational Site Number 250033
Investigational Site Number 250032
Investigational Site Number 250007


title: Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease

acronym: LixiPark

summary: The main objective of the study is to evaluate the effect of lixisenatide (20 μg/d), versus placebo, administered as add-on therapy with the usual antiparkinsonian treatment, on the progression of motor disability in patients with early PD in order to assess its potential "disease-modifying" effect.

location_facility:
University Hospital of Marseille
CHU Toulouse
University Hospital of Bordeaux
University Hospital of Amiens
University Hospital of Lille
University Hospital of Lyon
University Hospital of Nancy
University Hospital of Rennes
University Hospital of Strasbourg
University Hospital of Rouen
University Hospital of Caen
University Hospital of Clermont-Ferrand
University Hospital of Montpellier
University Hospital of Nice
University Hospital of Besancon
Pitié Salpêtrière Hospital
Creteil- Henri Mondor Hospital
University Hospital of Nantes
University Hospital of Poitiers
University Hospital of Limoges


title: Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE in the Treatment of Critical Limb Ischemia Lesions in the Absence of a Suitable Autologous Vein

acronym: REPLACE

summary:
Open repair could be recommended in a first line of treatment to revascularize critical limb ischemia patients or performed in a second line of treatment in case of failure of endovascular repair. A good quality vein is one of the main factors that influence the clinical success of open revascularization for below-knee popliteal. In the absence of an suitable autologous vein, prosthesis such as polytetrafluoroethylen (PTFE) graft could be an option but demonstrated worse clinical and morphological results compared to autologous greater saphenous vein. Consequently, there is still a room for improvement in CLI patients in the absence of an suitable autologous vein in whom endovascular repair failed.

Recently, PTFE with heparin-bound to the luminal surface (Hb-PTFE) significantly reduced the overall risk of primary graft failure by 37%, in particular, risk reduction was 50% in femoropopliteal bypass cases in cases with critical ischemia (58% Primary patency for crude ePTFE versus 80% primary patency for PROPATEN at 1 year follow-up) (Lindholt, et. al. 2011).

Additionally, a weighted average from the literature suggests a 76% primary patency for below knee bypasses performed with PROPATEN at one year follow-up, whereas a published meta-analysis suggests a 59% primary patency for below knee crude ePTFE at one year follow-up. At two year follow-up using the same approach, the average primary patency for PROPATEN was 67% versus 43% for standard ePTFE.

The aim of this study is to assess PTFE with heparin-bound to the luminal surface as an alternative to crude PTFE in absence of good venous conduit in patients with CLI.

location_facility: Lyon University Hospital - Hopital Edouard Herriot

location_facility: Bordeaux University Hospital - Hôpital Pellegrin


title: Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy

acronym: VIVROVAIRE TR

summary:
While they are documented in patients in remission of testicular cancer, the sequelae of chemotherapy and the impact of the disease and its treatments on the living conditions and QoL of women in remission of rare ovarian cancer remain poorly explored.

The coordinator therefore propose a national 2-step case-control study to evaluate 1) chronic fatigue and QoL and 2) chemotherapy-related sequelae in adult patients in remission of surgery-treated TGMO or TSCS (conservative or not) supplemented with chemotherapy

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Léon Berard
Centre François Baclesse
Centre Paul Papin
CH Fleyriat
Centre Catherine de Sienne
Institut de Cancérologie de l'Ouest
Institut Curie,
CHU Poitiers
Institut Rennais de Cancérologie
Centre Jean Perrin
Institut Jean Godinot
GH Cochin Broca Hôtel-Dieu
Institut Paoli Calmettes
HEGP
Hôpital Diaconesses-Croix St Simon
CHRU Stasbourg Hôpital Civil
Institut Bergonié
Institut Gustave Roussy
CHU Besançon Jean MINJOZ


type: Other Grant/Funding Number

title: A Multicenter Prospective Phase II Study of Postoperative Hypofractionated Stereotactic Body Radiotherapy (SBRT) in the Treatment of Early Stage Oropharyngeal and Oral Cavity Cancers With High Risk Margins.

acronym: STEREOPOSTOP

summary: The main objective of this national, open-label, non-randomized phase II trial is to evaluate severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (SBRT) in the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins.

ReferenceCitation: Biau J, Thivat E, Millardet C, Saroul N, Pham-Dang N, Molnar I, Pereira B, Durando X, Bourhis J, Lapeyre M. A multicenter prospective phase II study of postoperative hypofractionated stereotactic body radiotherapy (SBRT) in the treatment of early-stage oropharyngeal and oral cavity cancers with high risk margins: the STEREO POSTOP GORTEC 2017-03 trial. BMC Cancer. 2020 Aug 5;20(1):730. doi: 10.1186/s12885-020-07231-3.

family: Biau

full_name: Julian Biau

given: Julian

family: Thivat

full_name: Emilie Thivat

given: Emilie

family: Millardet

full_name: Corinne Millardet

given: Corinne

family: Saroul

full_name: Nicolas Saroul

given: Nicolas

family: Pham-Dang

full_name: Nathalie Pham-Dang

given: Nathalie

family: Molnar

full_name: Ioana Molnar

given: Ioana

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Durando

full_name: Xavier Durando

given: Xavier

family: Bourhis

full_name: Jean Bourhis

given: Jean

family: Lapeyre

full_name: Michel Lapeyre

given: Michel

journal_name: BMC Cancer

repository_institution: Université de Lausanne - SERVAL

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Jean Perrin

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Hôpital Haut-Lévêque - Groupe hospitalier sud - CHU de Bordeaux

location_facility: Institut de Cancérologie de l'ouest, Site René Gauducheau

location_facility: Centre Hospitalier de Bretagne Sud /Site du Scorff

location_facility: Institut de Cancérologie de Montpellier, Val d'Aurelle

location_facility: Hôpital Universitaire Pitié Salpêtrière - Charles Foix

intervention_type: Radiation


title: The Artificial Kidney Initiation in Kidney Injury 2 A Multi-Centre, Randomized, Controlled Trial

summary: The timing of renal replacement therapy (RRT) in the context of severe acute kidney injury (AKI) is one the most debated issues in critical care medicine. The Artificial Kidney Initiation in Kidney Injury (AKIKI) was the first large prospective multicenter randomized trial published on this topic. This study (published in the New England Journal of Medicine, July 2017) showed no significant difference between an early and delayed RRT initiation strategy in term of mortality. Nearly 50% of patients escaped RRT in the delayed strategy and this strategy was associated with less catheter-related infections and faster renal function recovery. Two (serum urea concentration >40 mmol/l and oliguria/anuria for more than 72 hours) of the 5 criteria which mandated RRT in the delayed strategy are still open to debate since they have never been shown to put patient at danger. To go further into our investigation of RRT criteria, the investigators designed a study that would compare the "delayed strategy" used in AKIKI that can now be considered as "standard" with another in which RRT is delayed for a longer period in the absence of a life-threatening complication (such as hyperkalemia or severe overload pulmonary edema).

ReferenceCitation: Gaudry S, Hajage D, Martin-Lefevre L, Lebbah S, Louis G, Moschietto S, Titeca-Beauport D, Combe B, Pons B, de Prost N, Besset S, Combes A, Robine A, Beuzelin M, Badie J, Chevrel G, Bohé J, Coupez E, Chudeau N, Barbar S, Vinsonneau C, Forel JM, Thevenin D, Boulet E, Lakhal K, Aissaoui N, Grange S, Leone M, Lacave G, Nseir S, Poirson F, Mayaux J, Asehnoune K, Geri G, Klouche K, Thiery G, Argaud L, Rozec B, Cadoz C, Andreu P, Reignier J, Ricard JD, Quenot JP, Dreyfuss D. Comparison of two delayed strategies for renal replacement therapy initiation for severe acute kidney injury (AKIKI 2): a multicentre, open-label, randomised, controlled trial. Lancet. 2021 Apr 3;397(10281):1293-1300. doi: 10.1016/S0140-6736(21)00350-0.

family: Gaudry

full_name: Stéphane Gaudry

given: Stéphane

family: Hajage

full_name: David Hajage

given: David

family: Martin-Lefevre

full_name: Laurent Martin-Lefevre

given: Laurent

family: Lebbah

full_name: Saïd Lebbah

given: Saïd

family: Louis

full_name: Guillaume Louis

given: Guillaume

family: Moschietto

full_name: Sébastien Moschietto

given: Sébastien

family: Titeca-Beauport

full_name: Dimitri Titeca-Beauport

given: Dimitri

family: Combe

full_name: Béatrice La Combe

given: Béatrice La

family: Pons

full_name: Bertrand Pons

given: Bertrand

family: de Prost

full_name: Nicolas de Prost

family: Besset

full_name: Sébastien Besset

family: Combes

full_name: Alain Combes

given: Alain

family: Robine

full_name: Adrien Robine

given: Adrien

family: Beuzelin

full_name: Marion Beuzelin

given: Marion

family: Badie

full_name: Julio Badie

given: Julio

family: Chevrel

full_name: Guillaume Chevrel

family: Bohé

full_name: Julien Bohé

given: Julien

family: Coupez

full_name: Elisabeth Coupez

given: Elisabeth

family: Chudeau

full_name: Nicolas Chudeau

family: Barbar

full_name: Saber Barbar

given: Saber

family: Vinsonneau

full_name: Christophe Vinsonneau

given: Christophe

family: Forel

full_name: Jean-Marie Forel

given: Jean-Marie

family: Thevenin

full_name: Didier Thevenin

given: Didier

ReferenceCitation: Meraz-Muñoz AY, Bagshaw SM, Wald R. Timing of kidney replacement therapy initiation in acute kidney injury. Curr Opin Nephrol Hypertens. 2021 May 1;30(3):332-338. doi: 10.1097/MNH.0000000000000707. Review.

journal_name: Current Opinion in Nephrology & Hypertension

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Gaudry S, Hajage D, Martin-Lefevre L, Louis G, Moschietto S, Titeca-Beauport D, La Combe B, Pons B, de Prost N, Besset S, Combes A, Robine A, Beuzelin M, Badie J, Chevrel G, Reignier J, Bohé J, Coupez E, Chudeau N, Barbar S, Vinsonneau C, Forel JM, Thevenin D, Boulet E, Lakhal K, Aissaoui N, Grange S, Leone M, Lacave G, Nseir S, Poirson F, Mayaux J, Asehnoune K, Geri G, Klouche K, Thiery G, Argaud L, Ricard JD, Quenot JP, Dreyfuss D. The Artificial Kidney Initiation in Kidney Injury 2 (AKIKI2): study protocol for a randomized controlled trial. Trials. 2019 Dec 16;20(1):726. doi: 10.1186/s13063-019-3774-9.

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

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

location_facility: Groupe Hospitalier Carnelle-Portes de l'Oise Site Beaumont / Oise

location_facility: Hotel Dieu - Réanimation MIR - CHU Nantes

location_facility: CHU Pitié-Salpêtrière - Réanimation médicale - APHP

location_facility: CHU Pitiè Salpêtrière - Pneumologie et réanimation médicale - APHP

location_facility: Hotel Dieu - Anesthésie Réanimation - CHU Nantes

location_facility: Centre Hospitalier Bretagne sud - Lorient


title: Mucormycosis in ICU: A French Multicenter Cohort Study

acronym: ZygoRéa

summary:
Mucormycosis is an invasive fungal infection affecting patients with various clinical conditions especially patients with heavy immunosuppression or patients with trauma or extensive burns.

ZygoRéa is a retrospective and multicentric French study aimed to evaluate survival of patients with mucormycosis admitted in ICU at day-28 after admission. This study will also try also to describe the epidemiology of patients admitted in ICU.

status: Unknown status

lead_sponsor: University Hospital, Grenoble

location_facility: Intensive Care Unit - Hospital Montpellier

location_facility: Intensive Care Unit - Hospital Grenoble Alpes

location_facility: Intensive Care Unit - Hospital Clermont-Ferrand

location_facility: Intensive Care Unit - Hospital Saint Louis

location_facility: Intensive Care Unit - Hospital l'Archet - Nice

location_facility: Intensive Care Unit - Hospital Saint Etienne

status_simplified: Unknown


title: Evaluation of a Standardized Medical Regulation Strategy on the Reduction of Deliveries Outside Medical Presence.

acronym: REGUL-AIpM

summary: The purpose of this study is to prospectively evaluate a standardized procedure of medical regulation based on a validated predictive score of eminent delivery (SPIA) in comparison with usual inhomogeneous practices. This standardized procedure impacting the process of care production (when receiving the call for regulation for unannounced delivery) would improve the quality of care of parturients while rationalizing the use of medical teams in the field.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Centre Hospitalier Universitaire Avicenne

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Régional Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier Universitaire de la Réunion

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Régional Mets-Thionville

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Grenoble


title: Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation

acronym: ConFIRM

summary: The purpose of this study is to compare the efficiency of conversion to IUI and IVF in patients with a poor ovarian response to stimulation

ReferenceCitation: Delbos L, Parot-Schinkel E, El Hachem H, Legendre G, Descamps P, Boucret L, Ferré-L'Hotellier V, Jeanneteau P, Dreux C, Morinière C, May-Panloup P, Bouet PE. ConFIRM trial - conversion of in vitro fertilization cycles to intrauterine inseminations in patients with a poor ovarian response to stimulation: a protocol for a multicentric, prospective randomized trial. Trials. 2018 Oct 17;19(1):565. doi: 10.1186/s13063-018-2936-5.

family: Delbos

full_name: Léa Delbos

given: Léa

family: Parot-Schinkel

full_name: Elsa Parot-Schinkel

given: Elsa

family: El Hachem

full_name: Hady El Hachem

given: Hady

family: Legendre

full_name: Guillaume Legendre

family: Descamps

full_name: Philippe Descamps

given: Philippe

family: Boucret

full_name: Lisa Boucret

given: Lisa

family: Ferré-L’Hotellier

full_name: Véronique Ferré-L’Hotellier

given: Véronique

family: Jeanneteau

full_name: Pauline Jeanneteau

given: Pauline

family: Dreux

full_name: Cécile Dreux

given: Cécile

family: Morinière

full_name: Catherine Morinière

given: Catherine

family: May-Panloup

full_name: Pascale May-Panloup

given: Pascale

family: Bouet

full_name: Pierre-Emmanuel Bouet

given: Pierre-Emmanuel

lead_sponsor: University Hospital, Angers

location_facility:
UH Strasbourg
UH Nantes
UH Grenoble
Clinique Jules Verne
UH Pointe-à-Pitre
Clinique Léonard de Vinci
IHC Créteil
Clinique Mutualiste de la Sagesse
UHR Tours
Antoine Béclère Hospital AP-HP
UH Angers
Polyclinique Jean Villar
Polyclinique de L'Atlantique
UH Caen
Lorient Hospital
UH La conception AP-HM
UH Rennes
Clinique Pierre Cherest