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.

lead_sponsor: Hospices Civils de Lyon

location_facility: Département de Chirurgie Vasculaire, CHU de Rouen

location_facility: Département de Chirurgie Vasculaire, CHU d'Angers

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

location_facility: Hospices Civils de Lyon, Hôpital Edouard Herriot

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

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

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

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

location_facility: Département de Chirurgie Vasculaire, APHP Hôpital Ambroise Paré

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

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

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

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

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

location_facility: Département de Chirurgie Vasculaire, CHU Pontchailloux Rennes

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

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

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 J. Minjoz Besançon

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

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

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

location_facility: Département de Chirurgie Vasculaire, APHP Hôpital Henri Mondor


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.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Classe JM, Ferron G, Ouldamer L, Gauthier T, Emambux S, Gladieff L, Dupre PF, Anota A. CHRONO: randomized trial of the CHROnology of surgery after Neoadjuvant chemotherapy for Ovarian cancer. Int J Gynecol Cancer. 2022 Aug 1;32(8):1071-1075. doi: 10.1136/ijgc-2021-003320.

lead_sponsor: ARCAGY/ GINECO GROUP

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 Hospitalier Universitaire Bretonneau

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

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire

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

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

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Ongoing


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.

ipd_sharing: No

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Groupe Hospitalier Diaconesses Crois Saint Simon

intervention_type: Drug


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.

study_type: Observational

time_perspective: Prospective

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

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: APHP - Hôpital Européen Georges Pompidou

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Other

lead_sponsor_type: academique


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)

lead_sponsor: Groupe Francophone des Myelodysplasies

location_country: France Italy

location_facility: Institut Paoli Calmettes/Unité d'Hématologie 3

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

location_facility: Hôpital Archet 1/Service d'Hématologie Clinique

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

location_facility: Centre Hospitalier de Versailles-Hôpital André Mignot

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

location_facility: CHU Hôtel Dieu/Service d'Hématologie Clinique

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

location_facility: CH Le Mans/Service d'hématologie Oncologie

location_facility: institut de cancérologie Lucien Neuwirth

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

location_facility: Hôpital Saint Louis - Hématologie Séniors

location_facility: Ematologia ed Immunologia Clinica PADOVA


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

primary_purpose: Other

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 GRENOBLE Alpes - Hôpital Couple-Enfant

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


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.

status: Active, not recruiting

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

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


ipd_sharing: Undecided

acronym: DICIPLE

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

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

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.

ReferenceType: background

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.

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: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

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.

status: Completed

study_completion_date_type: Actual

time_perspective: Cross-Sectional

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

location_country: France Switzerland Italy

location_facility: Città della Salute e della Scienza Hospital

location_facility: Service de cardiologie, Polyclinique Vauban

location_facility: Service de cardiologie, CHU Saint Etienne

location_facility: Service de cardiologie, Clinique Saint Joseph

location_facility: Service de cardiologie, CHR Metz Thionville

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

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Service de cardiologie, Centre Cardiologique du Nord

location_facility: Service de cardiologie, CH Annecy Genevois

location_facility: Service de cardiologie, Hôpital privé du Confluent

intervention_type: Diagnostic Test

status_simplified: Completed


type: Other Identifier

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_description: Qualified researchers may request access to patient 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. Patient 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://vivli.org

lead_sponsor: Sanofi

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


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.

status: Unknown status

lead_sponsor: University Hospital, Toulouse

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

status_simplified: Unknown


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.

lead_sponsor: Nantes University Hospital

location_facility: Bordeaux University Hospital - Hôpital Pellegrin

location_facility: Lyon University Hospital - Hopital Edouard Herriot


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


title: "Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series"

acronym: BIOPSYN

summary: Synovial biopsies are now routinely performed both in research and in clinical practice. The developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated their use and tolerance by the patients. However, their interest in clinical practice in the context of an undifferentiated arthritis remains debated.

location_facility:
CHU de Nice
Chu de Rennes
CHD La Roche-sur-Yon
CHU de Nancy
CHU de Poitiers
Chu de Dijon
Chu de Toulouse
CHU CAEN
Chu Brest
AP-HM
CHU de Bordeaux
Chu d'Angers
Chu de Strasbourg
AP-HP
Chu de Montpellier


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.

lead_sponsor: Centre Jean Perrin

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

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier de Bretagne Sud /Site du Scorff

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

location_facility: Hôpital Universitaire Pitié Salpêtrière - Charles Foix

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

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.

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.

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.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: France Guadeloupe

location_facility: Hotel Dieu - Réanimation MIR - CHU Nantes

location_facility: Hotel Dieu - Anesthésie Réanimation - CHU Nantes

location_facility: Centre Hospitalier Bretagne sud - Lorient

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

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

location_facility: CHU Pitié-Salpêtrière - Réanimation médicale - APHP


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.

time_perspective: Retrospective

lead_sponsor: University Hospital, Grenoble

location_facility: Intensive Care Unit - Hospital Grenoble Alpes

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

location_facility: Intensive Care Unit - Hospital Saint Etienne

location_facility: Intensive Care Unit - Hospital Saint Louis

location_facility: Intensive Care Unit - Hospital Clermont-Ferrand

location_facility: Intensive Care Unit - Hospital Montpellier


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 de Dijon

location_facility: Centre Hospitalier Régional Mets-Thionville

location_facility: Centre Hospitalier Universitaire Avicenne

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de la Réunion

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Régional Universitaire de Besançon


title: A Multicenter Observational Cohort for HIV Infected Patients With a Cancer Treated by Immune-Checkpoint Inhibitors.

acronym: OncoVIHAC

summary:
A Multicenter, Observational, National Cohort for HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors (ICPi) for less than one month or to be treated with an ICPi such as anti-PD-1 or anti-PDL-1 or anti-CTLA4, monitored in some French hospitals .

The objective of the study is to assess the safety of these new agents in HIV-infected patients.

As an observatory, the number of participants planned is not predetermined: the aim is to include for 2 years any participant infected with HIV and having a cancer treated by ICPi in one of the centers that have agreed to participate.

50 participants will be recruited for Substudy "OncoVIRIM" during the study period (regardless of tumor type or ICPi type); 8 or 9 time points (blood samples) will be scheduled

The cohort " ANRS CO24 OncoVIHAC " is declared to authorities like category 2 research .

No intervention in the observatory, a collection of data will be carried out in M0, M6, M12, M18 and M24.

For the physiopathological Substudy OncoVIRIM : Blood samples will be collected to constitute cell bank, plasma bank, serum bank, DNA bank in order to meet the objectives of this substudy and possibly for complementary research

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Servide de Dermatologie - Hôpital Saint-Louis

location_facility: Service d'hématologie - Hôpital Gabriel Montpied

location_facility: Service Infectiologie - Hôpital de l'Hôtel-Dieu

location_facility: Pôle de Médecine 2 - Centre Hospitalier Andrée Rosemon

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpital Jean Minjoz

location_facility: Service des Maladies Infectieuses - Hôpital Saint Antoine

location_facility: Service de pneumologie - Hôpital Yves Le Foll

location_facility: Service Médecine interne - Maladies Infectieuses - Hôpital Yves Le Foll

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpital Gui de Chauliac

location_facility: Service d'Hématologie Oncologie - Centre Hospitalier du Pays d'Aix

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Service d'Oncologie Médicale - Hôpital Pitié-Salpêtrière

location_facility: Service des Maladies Infectieuses - Hôpital Saint-Louis

location_facility: Service de médecine interne Cancérologie - Hôpital l'Archet

location_facility: Service de Médecine interne et Maladies infectieuses - Hôpital André Mignot

location_facility: Service de Pneumologie - Hôpital St Joseph

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpital l'Archet

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpital de la Croix Rousse

location_facility: Service d'Immunologie Clinique - Hôpital Henri Mondor

location_facility: Service d'Onco-Hématologie Immunodépression - Hôpital Henri Duffaut

location_facility: Service d'oncologie multidiscliplinaire - Hôpital Nord

location_facility: Service d'immuno-pathologie clinique - Hôpital Saint-Louis

location_facility: Service de Médecine interne-Immunologie clinique - Hôpital Bicêtre

location_facility: Chirurgie Urologique et Tranplantation Rénale - Hôpital de la Conception

location_facility: Service de Médecine Interne - Hôpital Foch

location_facility: Service d'Oncologie médicale - Hôpital de la Timone

location_facility: Le Trait d'Union - Hôpitaux Universitaires de Strasbourg

location_facility: Service de Médecine interne - Hôpital Antoine Béclère

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpital Purpan

location_facility: Département d'Innovation Thérapeutique et d'Essais Précoces - Institut Gustave Roussy

location_facility: Service de Médecine interne - Centre Hospitalier Intercommunal

location_facility: Service de dermatologie - Hôpital St Joseph

location_facility: Service Hématologie Clinique - Hôpital Pitié-Salpêtrière

location_facility: Service dermatologie/vénéréologie - Hôpital de la Timone

location_facility: Service d'Immunologie Clinique - Hôpital européen Georges Pompidou

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpital Pitié-Salpêtrière

location_facility: Service des Maladies Infectieuses et du Voyageur - Centre Hospitalier de Tourcoing

location_facility: Service Oncologie Médicale - Centre Hospitalier Intercommunal

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpital Gabriel Montpied

location_facility: Service d'hématologie et oncologie - Hôpital André Mignot

location_facility: Service de Cancérologie Médicale - Hôpital européen Georges Pompidou

location_facility: Service Oncologie Hématologie - Hôpital Yves Le Foll

location_facility: Service d'Immunologie - Hôpital Felix Guyon

location_facility: Service de pneumologie - Hôpital Victor Dupouy

location_facility: Service d'hématologie-Cisih - Hôpital Sainte Marguerite

location_facility: Service de Dermatologie - Hôpital l'Archet

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de pneumologie - Centre Hospitalier Intercommunal

location_facility: Ambulatoire-Hôpital de Jour - Institut Paoli Calmettes

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpital Tenon

location_facility: Service de Médecine Interne - Centre Hospitalier de Martigues

location_facility: Service Hémopathies Lymphoïdes - Hôpital Henri Mondor

location_facility: Service de Médecine Interne - Hôpital d'Instruction des Armées Saint Anne

intervention_type: Biological


title: Randomized Phase III Study Testing Nivolumab and Ipilimumab Versus a Carboplatin Based Doublet in First Line Treatment of PS 2 or Elderly (More Than 70 Years Old) Patients With Advanced Non-small Cell Lung Cancer

acronym: eNERGY

summary:
Lung cancer is the most common cancer in the world and the leading cause of cancer-related deaths in Western countries. Unfortunately, at the time of diagnosis, the majority of patients already have metastatic disease and a systemic, palliative treatment is the primary therapeutic option.

Guidelines for PS 2 patients or older than 75 years old patients at the time of diagnosis recommend for fit patients a carboplatin doublet chemotherapy.

Nivolumab has proven efficacy in 3rd line squamous cell lung carcinoma and is superior to chemotherapy in 2nd line treatment of squamous and non-squamous lung cancer in term of overall survival.

In 1st line, nivolumab failed to show superiority compared to a platin based doublet in terms of progression free survival and overall survival in tumors ≥ 5% PD-L1 expression. The association Nivolumab plus Ipilimumab showed encouraging results in first line setting in phase 1 study.

The investigators think that with regard to the manageable toxicity of nivolumab in lung cancer population and the possibility to obtain long responses, this association could be a valid option for this population of elderly and/or PS2 patients in term of overall survival.

lead_sponsor: Rennes University Hospital

location_facility: CH Intercommunal Toulon-La Seyne-sur-Mer


title: Non-inferiority Study of the Pursuit of Enteral Nutrition Compared to a Strategy of Gastric Emptiness Peri-extubation. Cluster Randomized Trial

acronym: AMBROISIE

summary:
Approximately 50 to 60% of ICU patients are subjected to invasive mechanical ventilation-through a tracheal tube. Extubation consists of a key moment for the patient on the road to recovery (1). The extubation failure, is a major disease event. The incidence of extubation failure vary between studies between 10% and 20% of ventilated patients over 48 hours, it is therefore a significant risk including at the individual level. Ultimately, it is observed higher mortality for patients with unsuccessful extubation and this independently of their overall severity (2,3). Among the complications associated with extubation failure observed the occurrence of nosocomial pneumonia. Large-scale epidemiological data, covering nearly half of French ICUs found a risk of nosocomial pneumonia multiplied by a factor of 3 in case of extubation failure. Observing this strong association between nosocomial pneumonia and extubation failure does not presage a causal link. In all cases the onset of pneumonia probably involved in the morbidity and mortality of patients undergoing a failed extubation(4).

Prevention of inhalation may limit congestion and bronchial and lung infection, and thereby reduce the risk of extubation failure. Indeed, the primary pathophysiologic mechanism responsible for nosocomial bronchopulmonary infection is inhalation of oropharyngeal and digestive secretions (5).

This risk of inhalation during intubation motivates the implementation of fasting prior to general anesthesia for elective surgery patients. Indeed, it is recommended to respect a 6-hour fast for solids and 2 hours for liquid (water, fruit juices without pulp, tea or coffee without milk) in this situation (9).

Although the situations are very different from the context of programmed anesthesia and extubation followed by a possible emergency reintubation on failure of extubation in the context of resuscitation, fasting appears as a potential means of limit the inhalation during the period of risk posed extubation and reintubation eventual resuscitation. Nevertheless, it is doubtful of the effectiveness of the single fasting to ensure gastric emptiness during the period of extubation. Indeed, a very large proportion of patients presents the delayed gastric emptying causing prolonged gastric fluid stasis. (10).

Fasting and aspiration of gastric contents through a stomach tube has not, to our knowledge, never been rigorously evaluated in the ICU extubation.

Moreover, the setting of fasting patients is likely to induce significant side effects first and foremost, a charge extra care for paramedics. The other major effect is the calorie deficit induced potential source of infectious complications and a delay in extubation.

ReferenceCitation: Landais M, Nay MA, Auchabie J, Hubert N, Rebion A, Robert A, Giraudeau B, Reignier J, Thille AW, Tavernier E, Ehrmann S. Continuous enteral nutrition compared with a maximal gastric vacuity strategy at the time of extubation in the intensive care unit: protocol for a non-inferiority cluster randomised trial (the Ambroisie Project). BMJ Open. 2021 May 20;11(5):e041799. doi: 10.1136/bmjopen-2020-041799.

lead_sponsor: Centre Hospitalier le Mans

location_facility: Réanimation polyvalente-Centre Hospitalier Départemental Vendée

location_facility: Médecine Intensive Réanimation-CH ORLEANS

location_facility: Réanimation médico-chirurgicale- CH LE MANS

location_facility: Réanimation polyvalente-CHG SAINT NAZAIRE

location_facility: Réanimation médico-chirurgicale-CH PARIS ST JOSEPH

location_facility: Réanimation et Soins Continus-CHI de CORNOUAILLE


type: Registry Identifier

title: Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer: A Randomized Multicentre Phase II Study

acronym: Bladder-ART

summary:
This is a randomized multicentre study in patients with high-risk MIBC to investigate adjuvant radiotherapy after radical cystectomy and pelvic lymph node dissection.

The objective of the study is to provide evidence that adjuvant radiotherapy improves loco-regional control with potential benefits in survival. The study will also evaluate the quality of life of patients and the tolerance of the treatment.

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.

acronym: FRAGIREA

summary:
Study design. The study FRAGIREA is a multicentric prevalence study on the frequency of frailty among elderly patients and the quality of management. The voluntary ICUs will have to include all patients ≥ 70 years on a limited period (1 month) or until the number of 15 inclusions is reached. The frailty is going to be evaluated by a frailty score adapted to the ICU, based on informations given by the patient's family.

It is a descriptive non-interventional study, aiming at the description of frequency of frailty and management of the patient in order to set-up a prospective future study on the potential role of early rehabilitation of ageing patients in ICUs.

lead_sponsor: Hospices Civils de Lyon

location_country: France Mayotte

location_facility:
CHU Clermont-Ferrand
AP-HM Hôpital Nord
Hôpital Edouard Herriot, N réa
CHU Angers
CH Belfort
Centre Hospitalier Lyon Sud Réa Nord
CH Sud Francilien
Hôpital Edouard Herriot, G Réa
CH Bourgoin-Jallieu
CH Chambéry
CHU Rennes
CH Bourg en Bresse
CH Montélimar
Centre Hospitalier Lyon Sud
CHU Nice
CHU de Rennes
CH Annecy
CH Moulins
CH Mayotte
CH Chalons sur Saône
CHU Poitiers
CHU Rouen
CHU Hôpital Nord
CHU Grenoble
CH Argentueil
Hôpital Edouard Herriot, P Réa
CH Montauban
CH Vichy
AP-HM La Timone
CHU Nantes
CH Aix en Provence
CH Annonay
CH Saint Denis
CH Salons de Provence
CH Béziers
Hôpital de la Croix Rousse
CH Valence


title: Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease: a Prospective, Multicenter, Randomized, Open-label, Clinical Trial

acronym: MASTER-ANCA

summary:
This prospective randomized trial aims to evaluate the feasibility, risk and benefit of the discontinuation of immunosuppressive maintenance treatments in AAV (Antineutrophil Cytoplasmic Autoantibodies (ANCA)-associated vasculitis) patients who have reached ESRD (end-stage renal disease). Our hypothesis is that discontinuation of immunosuppressive therapy in AAV patients with ESRD will not expose these patients to an excessive risk of extra-renal AAV relapse, while reducing the rate of complications due to immunosuppression, particularly infections.

Patients with ESRD related to AAV will be randomized into 2 arms:

arm 1: discontinuation (or not initiation) of maintenance treatment (Experimental group) arm 2: maintenance (or initiation) of immunosuppressive treatment (Control group).

The main objective of this study is to demonstrate a superiority of immunosuppression discontinuation in ESRD-AAV patients compared to standard maintenance immunosuppressive therapy in terms of severe prejudicial event-free survival at 24 months. The second objectives include the frequency of major and minor relapses, of infectious episodes and leukopenia in both groups and the establishment of a prospective database regarding the outcome of ESRD-AAV patients.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Centre Hospitalier Universitaire Strasbourg

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier René Dubois - Pontoise

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire Saint Etienne

location_facility: Centre Hospitalier Universitaire G. Montpied

location_facility: Centre Hospitalier Universitaire Bordeaux

location_facility: Centre Hospitalier Universitaire Lapeyronie

location_facility: Centre Hospitalier Universitaire Poitiers

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Centre Hospitalier Universitaire Grenoble


title: Administration of PCC in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants: Impact of an Expert ECRF on Adherence to Rules of Proper Use and Outcome

summary: The study is assessing the impact of an expert eCRF on the management of severe bleeding in the administration of Prothrombin Complex Concentrate in patients treated with oral anticoagulants and adherence to recommendations or experts' consensus

lead_sponsor: Octapharma

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation

location_facility: Centre Hospitalier Régional Metz-Thionville Hôpital Mercy

location_facility: Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences

location_facility: Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle

location_facility: Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz

location_facility: Centre Hospitalier Chalon-sur-Saône William Morey

location_facility: Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences

location_facility: Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation

location_facility: Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences

location_facility: Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences

location_facility: Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche

location_facility: Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil

location_facility: Groupe Hospitalier de la Haute-Saône Site de Vesoul

location_facility: Centre Hospitalier Universitaire de Nantes Hôtel-Dieu

location_facility: Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation

location_facility: Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou

location_facility: Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences


title: Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)

acronym: EPNEC

summary: Observational, multicentre, retrospective study on patients taken care according to the national guidelines. The objective is to define, after the diagnosis confirmation, the frequency of PD-L1 expression in patients with large-cell lung neuroendocrine carcinoma (NEC), whatever the stage of the disease, and to correlate this parameter to clinical data at the time of diagnosis, therapeutic response and survival. Large-cell NECs present a bad prognostic and there is no evidence of treatment for these patients with advanced disease in second ligne of treatment at that time. To demonstrate the PD-L1 expression in this type of cancer might have a major therapeutic impact in a close future to access immunotherapies.

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility: Centre Hospitalier Universitaire DUPUYTREN


title: Immunotherapy by Nivolumab After Prior Chemotherapy for HIV+ Patients With Advanced Non-small Cell Lung Cancer (NSCLC): IFCT-CHIVA2 Phase IIa Trial

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
NHC - Pneumologie
Paris - Pitié-salpêtrière
Montpellier - CHRU
CH Cahors
CH de Pau
AP-HM Hôpital Nord
Saint Brieuc - CHG
CH d'Avignon
Suresnes - Hopital Foch
APHP - Hopital Tenon - Pneumologie
CH de la Côte Basque
Hôpital de la Croix Rousse
CHU Toulouse - Pneumologie
Montpellier - ICM
CH
CHI Créteil
Centre Hospitalier - Pneumologie
Paris - APHP Bichat

summary: Two Phase III trials showed superiority in terms of efficacy and tolerance of nivolumab in second-line treatment compared to docetaxel in metastatic NSCLC in the general population, so it is important to evaluate this treatment in PLWHIV (Patient Living With HIV) in maximum security conditions, taking into account their specificities and complex underlying immunological status. As NSCLC in PLWHIV is a rare tumour, a phase 2 trial, using DCR (Disease Control Rate) data, would be able to recruit a sufficient number of patients, in a reasonable period of time, to provide a proof of concept of the safety and efficacy of nivolumab in this population. Therefore, we think that an open-label, one arm phase 2 trial, with a rapid accrual, would be currently a crucial approach and a window of opportunity to explore whether nivolumab could find its place in PLWHIV with NSCLC. Such a trial is typically a trial for an academic sponsor, experienced in PLWHIV with NSCLC, which previously showed its ability to recruit patients with such a rare disease as the IFCT did with the IFCT-1001 CHIVA trial, testing carboplatin plus pemetrexed followed by pemetrexed.


title: UroCCR Database: French Research Network for Kidney Cancer (National Multidisciplinary Clinical and Biological Database on Kidney Cancer)

acronym: UroCCR

summary:
Within the framework for kidney cancer care, with the recent diversification of treatment modalities of these tumors and the deployment of the concept of multidisciplinary team, it was considered necessary to adapt the research tools to reality of health-care for patients with kidney cancer.

UroCCR is the French research network for kidney cancer, funded by the French National Cancer Institute as part of the call for projects for clinical and biological databases (BCB). Depending on the case presentation and disease evolution, more than a thousand of different variables can be recorded. At the same time, biological samples (plasma, urine, healthy and tumor tissues) are collected.

This database contains a considerable number of information and high added value since it is the result of multiple expertises that make it not only a multidisciplinary tool but also multicenter, allowing fundamental, translational and clinical research.

ReferenceCitation: Bréhier G, Bouvier A, Besnier L, Willoteaux S, Nedelcu C, Culty T, Aubé C, Bigot P. Renal function after partial nephrectomy following intra-arterial embolization of renal tumors. Sci Rep. 2020 Dec 7;10(1):21352. doi: 10.1038/s41598-020-78461-5.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Européen Georges Pompidou - APHP


title: A Prospective, Multicentric, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.

acronym: MAINEPSAN

summary:
Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood of disease control and temporary remission. However, most patients have recurrent relapses that lead to damage and require repeated treatment associated with long-term morbidity and death.

Rituximab has been shown to be as effective as cyclophosphamide to induce remission and maintenance of remission in severe GPA and MPA patients, with an acceptable safety profile . Although rituximab is becoming the standard of care for maintenance therapy in these patients, relapse still occurs and the optimal duration of prednisone therapy remains debated.

On the one hand, most US studies use early withdrawal (6-12 months) because of feared side effects. On the other hand, most European trials propose late withdrawal (>18 months) given a lower observed relapse rate on long-term low dose glucocorticoids treatment.

In a systematic review and meta-analysis, glucocorticoids regimen was the most significant variable explaining the variability between the proportions of ANCA-associated vasculitis patients with relapses. Nevertheless, it was an indirect estimation of treatment effect because of the absence of dedicated randomized trial. This meta-analysis concluded that combined longer-term (i.e. >12 months) use of low dose prednisone or nonzero glucocorticoids target is associated with a 20% reduction of relapse compared to early withdrawal (i.e. ≤12 months).

The relapse rate in patients with early glucocorticoids (10-12 months) withdrawal was provided in two studies and was of 37 and 34%, respectively. By contrast, the relapse rate in patients with late prednisone withdrawal (18-24 months) and receiving rituximab as maintenance treatment was 14% at 24 months in the MAINRITSAN trial. Of note, the decision to withdraw glucocorticoids after 18 months was left to physician's discretion in this study and two thirds of the nonsevere relapses occurred when patients were off prednisone.

The trial detailed here is the first prospective trial evaluating the length of glucocorticoid administration as remission adjunctive treatment for patients with GPA or MPA.

primary_purpose: Prevention

location_facility: Hopitaux Universaitaire de Strasbourg Hopitaux


title: A Multi-Centre, Open Label, Single Arm, Phase IB/IIA, Trial of Taselisib (GDC0032) in PIK3CA-Related Overgrowth

acronym: TOTEM

summary:
Segmental overgrowth disorders are rare conditions characterised by abnormal growth which is usually asymmetric and confined to discrete parts of the body. We and others have identified mosaic activating mutations in the p110α catalytic subunit of phosphatidylinositol-3-kinase (PI3K; encoded by the PIK3CA gene) in a subset of overgrowth disorders. The PI3K-AKT-mTOR is a critical signalling pathway, which regulates cellular growth, proliferation and survival. Activating mutations in PIK3CA lead to increased activation of the PI3K-AKT-mTORC1 axis, which in turn promotes excessive growth in affected tissue.

The PIK3CA-related overgrowth spectrum is wide, and depends upon the timing of the founder mutation in embryogenesis, and potentially upon the exact mutation. Clinical presentation ranges from isolated enlargement of a digit, to extensive overgrowth of limbs, abdomen and in some cases the brain, and may be accompanied by vascular or lymphatic malformations. Associated morbidity can be profound, with functional impairment, debilitating haemorrhages and thromboses, coupled with neurological sequelae and, in some cases, death. At present, serial debulking surgery is the only available therapeutic option.

The identification of gain-of-function mutations in PI3K has raised the possibility of treatment with drugs that inhibit PIK3CA (the p110 alpha catalytic subunit of PI3K). Taselisib is a selective inhibitor of class I PI3Ks and has direct inhibitory activity of the p110α isoform with a Kiapp value of 0.29 nmol/l.

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU Hôtel Dieu
Hôpital Necker-Enfants malades
Hôpital Jeanne de Flandre
HCL - Hôpital femme-mère-enfant
CHU de Bordeaux - GH Pellegrin
Hôpital Sud
CHU La Réunion - Site GHSR
CHU d'Angers
Hôpital Raymond Poincaré (AP-HP)
Hôpital Arnaud de Villeneuve
Hôpital Larrey
CHU de Saint-Etienne Hôpital Nord
CHU de Nice - Hôpital l'Archet 2
Hôpital Trousseau
Hôpital Saint Eloi
CHU de Nancy - Hôpital de Brabois
Chu Dijon Bourgogne
CHU de Nancy


title: REduced Dose Versus Full-dose of Direct Oral Anticoagulant After uNprOvoked Venous thromboEmbolism. The RENOVE Open-label, Randomized, Controlled Trial.

acronym: RENOVE

summary:
Patients with unprovoked venous thromboembolism (VTE) or VTE associated with persistent risk factors have a high risk of recurrence after stopping anticoagulation. In these patients, international guidelines recommend indefinite anticoagulation. However, prolonged use of warfarin or DOAC at therapeutic dose is associated with a significant risk of bleeding. Consequently, it has been hypothesized that extended anticoagulation at lower dosage might be as effective as and safer than full dose of anticoagulation. However, low-dose warfarin (INR 1.5-2) was less effective and not safer than conventional dose warfarin (INR 2-3).

Low dose of DOAC has the potential to validate this hypothesis. In a first randomized trial comparing full-dose or low-dose apixaban with a placebo during an additional one year of anticoagulation in patients where physicians were uncertain for prolonging anticoagulation ("Amplify-extension trial"), low-dose apixaban was more effective than placebo without any major concern regarding safety and possibly as effective as and safer than full-dose apixaban; in a second randomized trial comparing full-dose or low-dose rivaroxaban with aspirin, during an additional one year of anticoagulation in patients where physicians were uncertain for prolonging anticoagulation ("Einstein-Choice trial"), low-dose rivaroxaban was more effective than aspirin without any major concern regarding safety and possibly as effective as and safer than full-dose rivaroxaban. However, these two studies were not designed and powered to demonstrate non-inferiority on efficacy and superiority on safety of a reduced dose of DOAC versus a full dose DOAC and the selected population did not have strong indications for indefinite anticoagulation. Thus, there is currently no evidence to recommend a reduced dose rather than a full dose of DOAC for extended therapy in patients at high risk of recurrent VTE. Consequently, a randomized trial comparing low-dose DOAC with full-dose DOAC therapy in patients at high risk of recurrent VTE is needed and justified.

Main hypothesis:

After VTE at high risk of recurrence initially treated during 6 (-15 days) to 24 (+ 3 months) uninterrupted months, a reduced dose of DOAC will be non-inferior to a full dose of DOAC in terms of recurrent VTE during extended anticoagulation phase.

lead_sponsor: University Hospital, Brest

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied

location_facility: CHU de Grenoble - Hôpital Nord Michallon

location_facility: CH de Saint Brieuc - Hôpital Yves Le Foll


title: A Phase II Trial Evaluating Combination of Atezolizumab, With Venetoclax and Obinutuzumab for Relapsed/Refractory Lymphomas

summary:
This study is a multicenter phase II trial which primary objective is to assess the anti-lymphoma activity of atezolizumab associated with a BCL-2 inhibitor (GDC-199, venetoclax) and an anti-CD20 monoclonal antibody (obinutuzumab) in three separate cohorts:

relapsed/refractory follicular lymphoma (FL) patients
relapsed/refractory aggressive (DLBCL) lymphoma patients
relapsed/refractory other indolent (iNHL) lymphoma patients (MZL and MALT)

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: A Randomized, Open-label, Multicentric Phase II Trial of PEMBROLIZUMAB (Keytruda®) With Chemotherapy Versus Chemotherapy Alone (Standard of Care) as Neo Adjuvant Treatment of Ovarian Cancer Not Amenable to Front Line Debulking Surgery.

acronym: NEOPEMBROV

summary:
There are several data suggesting that pembrolizumab and bevacizumab may be synergistic. Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells in patients. There is evidence in OC that tumor expression of VEGF is negatively correlated to the density of CD3+TILs and this phenotype is associated with early recurrence, consistent with prior studies showing a correlation of VEGF to early recurrence and short survival. Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+ cells

This randomized phase II study aims to evaluate the efficacy of pembrolizumab in combina-tion with the standard neo adjuvant chemotherapy followed by IDS and the safety of this strategy in patients with advanced ovarian cancer. We assume that its administration in the neo adjuvant setting combination with standard of care (4 cycles of standard chemotherapy) would improve the response rate and consequently will help to achieve optimal debulking rate at IDS.

After surgery, patients will continue to be treated with standard of care (chemotherapy for 2 to 5 cycles plus or less bevacizumab) or the same combination plus pembrolizumab (keytruda).

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Groupe Hospitalier Diaconesses-Croix Saint Simon

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier Départemental Les Oudairies


title: Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform: Evolution of the Therapeutic Care in Metastatic Breast Cancer Across the French Comprehensive Cancer Centers From 2008

acronym: ESME-MBC

summary: The Epidemiological Strategy and Medical Economic (ESME) Ovarian cancer Data Platform is a multi-center real life database using a retrospective data collection process (18 FCCCs over 20 sites). This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.

ReferenceType: result

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ReferenceCitation: Cabel L, Carton M, Cheaib B, Pierga JY, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Desmoulins I, Lefeuvre C, Gonçalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Perrocheau G, Piot I, Pérol D, Simon G, Lerebours F. Oral etoposide in heavily pre-treated metastatic breast cancer: results from the ESME cohort and comparison with other chemotherapy regimens. Breast Cancer Res Treat. 2019 Jan;173(2):397-406. doi: 10.1007/s10549-018-5017-2. Epub 2018 Oct 24.

ReferenceCitation: Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Mazouni C, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Gonçalves A, Jankowski C, De La Motte Rouge T, Pouget N, de La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Robain M, Filleron T, Cailliot C, Dalenc F. Survival Impact of Locoregional Treatment of the Primary Tumor in De Novo Metastatic Breast Cancers in a Large Multicentric Cohort Study: A Propensity Score-Matched Analysis. Ann Surg Oncol. 2019 Feb;26(2):356-365. doi: 10.1245/s10434-018-6831-9. Epub 2018 Dec 11.

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ReferenceCitation: Pérol D, Robain M, Delaloge S, Cailliot C. Routinely collected data may usefully supplement randomised controlled data on treatment effects for mortality. BMJ. 2016 Dec 16;355:i6745. doi: 10.1136/bmj.i6745.

ReferenceCitation: Petitjean A, Smith-Palmer J, Valentine W, Tehard B, Roze S. Cost-effectiveness of bevacizumab plus paclitaxel versus paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer in specialist oncology centers in France. BMC Cancer. 2019 Feb 11;19(1):140. doi: 10.1186/s12885-019-5335-8.

ReferenceCitation: Pérol D, Robain M, Arveux P, Mathoulin-Pélissier S, Chamorey E, Asselain B, Berchery D, Gourgou S, Breton M, Delaine-Clisant S, Mons M, Diéras V, Carton M, Guizard AV, Laborde L, Laurent C, Loeb A, Mouret-Reynier MA, Parent D, Perrocheau G, Campion L, Velten M, Cailliot C, Ezzalfani M, Simon G. The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the Epidemiological Strategy and Medical Economics (ESME). BMJ Open. 2019 Feb 21;9(2):e023568. doi: 10.1136/bmjopen-2018-023568.

ReferenceCitation: Jacot W, Heudel PE, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program. Int J Cancer. 2019 Dec 15;145(12):3359-3369. doi: 10.1002/ijc.32402. Epub 2019 Jun 20.

ReferenceCitation: Le Saux O, Lardy-Cleaud A, Frank S, Debled M, Cottu PH, Pistilli B, Vanlemmens L, Leheurteur M, Lévy C, Laborde L, Uwer L, D'hondt V, Berchery D, Lorgis V, Ferrero JM, Perrocheau G, Courtinard C, Mouret-Reynier MA, Velten M, Breton M, Parent D, Chabaud S, Robain M, Bachelot T. Assessment of the efficacy of successive endocrine therapies in hormone receptor-positive and HER2-negative metastatic breast cancer: a real-life multicentre national study. Eur J Cancer. 2019 Sep;118:131-141. doi: 10.1016/j.ejca.2019.06.014. Epub 2019 Jul 19.

ReferenceCitation: Gougis P, Carton M, Tchokothe C, Campone M, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Bachelot T, Hennequin A, Perrin C, Gonçalves A, Uwer L, Eymard JC, Petit T, Mouret-Reynier MA, Chamorey E, Simon G, Saghatchian M, Cailliot C, Le Tourneau C. CinéBreast-factors influencing the time to first metastatic recurrence in breast cancer: Analysis of real-life data from the French ESME MBC database. Breast. 2020 Feb;49:17-24. doi: 10.1016/j.breast.2019.10.004. Epub 2019 Oct 19.

ReferenceCitation: Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Debled M, Mouret-Reynier MA, Goncalves A, Dalenc F, Delaloge S, Campone M, Augereau P, Ferrero JM, Levy C, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Chevrot M, Pasquier D, Bachelot T. Impact of breast cancer molecular subtypes on the incidence, kinetics and prognosis of central nervous system metastases in a large multicentre real-life cohort. Br J Cancer. 2019 Dec;121(12):991-1000. doi: 10.1038/s41416-019-0619-y. Epub 2019 Nov 13.

ReferenceCitation: Pasquier D, Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Petit A, Mouret-Reynier MA, Goncalves A, Dalenc F, Deluche E, Fresnel JS, Augereau P, Ferrero JM, Geffrelot J, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Mouttet-Audouard R, Bachelot T, Courtinard C. Treatment and outcomes in patients with central nervous system metastases from breast cancer in the real-life ESME MBC cohort. Eur J Cancer. 2020 Jan;125:22-30. doi: 10.1016/j.ejca.2019.11.001. Epub 2019 Dec 10.

ReferenceCitation: Deluche E, Antoine A, Bachelot T, Lardy-Cleaud A, Dieras V, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Courtinard C, Perol D, Robain M, Delaloge S. Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008-2016. Eur J Cancer. 2020 Apr;129:60-70. doi: 10.1016/j.ejca.2020.01.016. Epub 2020 Mar 2.

ReferenceCitation: Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Rivera S, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Gonçalves A, Jankowski C, De La Motte Rouge T, Pouget N, De La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Courtinard C, Filleron T, Robain M, Dalenc F. Radiation therapy to the primary tumor for de novo metastatic breast cancer and overall survival in a retrospective multicenter cohort analysis. Radiother Oncol. 2020 Apr;145:109-116. doi: 10.1016/j.radonc.2019.12.019. Epub 2020 Jan 10.

ReferenceCitation: Heudel P, Delaloge S, Parent D, Madranges N, Levy C, Dalenc F, Brain E, Uwer L, D'Hondt V, Augereau P, Mailliez A, Perrin C, Frenel JS, Sablin MP, Mouret-Reynier MA, Vermeulin T, Eymard JC, Petit T, Ferrero JM, Ilie S, Goncalves A, Chenuc G, Robain M, Simon G, Perol D. Real-world Evaluation of Oral Vinorelbine in the Treatment of Metastatic Breast Cancer: An ESME-MBC Study. Anticancer Res. 2020 Jul;40(7):3905-3913. doi: 10.21873/anticanres.14381.

ReferenceCitation: Frasca M, Sabathe C, Delaloge S, Galvin A, Patsouris A, Levy C, Mouret-Reynier MA, Desmoulins I, Vanlemmens L, Bachelot T, Goncalves A, Perotin V, Uwer L, Frenel JS, Ferrero JM, Bouleuc C, Eymard JC, Dieras V, Leheurteur M, Petit T, Dalenc F, Jaffre A, Chevrot M, Courtinard C, Mathoulin-Pelissier S. Palliative care delivery according to age in 12,000 women with metastatic breast cancer: Analysis in the multicentre ESME-MBC cohort 2008-2016. Eur J Cancer. 2020 Sep;137:240-249. doi: 10.1016/j.ejca.2020.07.007. Epub 2020 Aug 14.

ReferenceCitation: Frank S, Carton M, Dubot C, Campone M, Pistilli B, Dalenc F, Mailliez A, Levy C, D'Hondt V, Debled M, Vermeulin T, Coudert B, Perrin C, Gonçalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Patsouris A, Guesmia T, Bachelot T, Robain M, Cottu P. Impact of age at diagnosis of metastatic breast cancer on overall survival in the real-life ESME metastatic breast cancer cohort. Breast. 2020 Aug;52:50-57. doi: 10.1016/j.breast.2020.04.009. Epub 2020 Apr 23.

ReferenceCitation: Saleh K, Carton M, Dieras V, Heudel PE, Brain E, D'Hondt V, Mailliez A, Patsouris A, Mouret-Reynier MA, Goncalves A, Ferrero JM, Petit T, Emile G, Uwer L, Debled M, Dalenc F, Jouannaud C, Ladoire S, Leheurteur M, Cottu P, Veron L, Savignoni A, Courtinard C, Robain M, Delaloge S, Deluche E. Impact of body mass index on overall survival in patients with metastatic breast cancer. Breast. 2021 Feb;55:16-24. doi: 10.1016/j.breast.2020.11.014. Epub 2020 Dec 1.

ReferenceCitation: Sirieix J, Fraisse J, Mathoulin-Pelissier S, Leheurteur M, Vanlemmens L, Jouannaud C, Diéras V, Lévy C, Ung M, Mouret-Reynier MA, Petit T, Coudert B, Brain E, Pistilli B, Ferrero JM, Goncalves A, Uwer L, Patsouris A, Tredan O, Courtinard C, Gourgou S, Frénel JS. Management and outcome of male metastatic breast cancer in the national multicenter observational research program Epidemiological Strategy and Medical Economics (ESME). Ther Adv Med Oncol. 2020 Dec 23;12:1758835920980548. doi: 10.1177/1758835920980548. eCollection 2020.

ReferenceCitation: Bertho M, Fraisse J, Patsouris A, Cottu P, Arnedos M, Pérol D, Jaffré A, Goncalves A, Lebitasy MP, D'Hondt V, Dalenc F, Ferrero JM, Levy C, Dabakuyo S, Rouzier R, Penault-Llorca F, Uwer L, Eymard JC, Breton M, Chevrot M, Thureau S, Petit T, Simon G, Frénel JS. Real-life prognosis of 5041 bone-only metastatic breast cancer patients in the multicenter national observational ESME program. Ther Adv Med Oncol. 2021 Jan 21;13:1758835920987657. doi: 10.1177/1758835920987657. eCollection 2021.

ReferenceCitation: Cabel L, Carton M, Pistilli B, Dalenc F, Vanlemnens L, Levy C, Jacot W, Debled M, Loeb A, Hennequin A, De la Motte Rouge T, Laborde L, Laurent C, Chamorey E, Parent D, Petit T, Mouret-Reynier MA, Campone M, Perrocheau G, Labreveux C, Bachelot T, Robain M, Lerebours F. Outcome beyond third-line chemotherapy for metastatic triple-negative breast cancer in the French ESME program. Breast. 2021 Apr;56:18-25. doi: 10.1016/j.breast.2021.01.006. Epub 2021 Jan 30.

ReferenceCitation: Hotton J, Lusque A, Leufflen L, Campone M, Levy C, Honart JF, Mailliez A, Debled M, Gutowski M, Leheurteur M, Gonçalves A, Jankowski C, Guillermet S, Bachelot T, Ferrero JM, Eymard JC, Petit T, Pouget N, de La Lande B, Frenel JS, Villacroux O, Simon G, Pons-Tostivint E, Marchal F. Early Locoregional Breast Surgery and Survival in de novo Metastatic Breast Cancer in the Multicenter National ESME Cohort. Ann Surg. 2021 Feb 1. doi: 10.1097/SLA.0000000000004767. [Epub ahead of print]

ReferenceCitation: Annonay M, Gauquelin L, Geiss R, Ung M, Cristol-Dalstein L, Mouret-Reynier MA, Goncalves A, Abadie-Lacourtoisie S, Francois E, Perrin C, Le Fel J, Lorgis V, Servent V, Uwer L, Jouannaud C, Leheurteur M, Joly F, Campion L, Courtinard C, Villacroux O, Petit T, Soubeyran P, Terret C, Bellera C, Brain E, Delaloge S. Treatment and outcomes of older versus younger women with HER2-positive metastatic breast cancer in the real-world national ESME database. Breast. 2021 Dec;60:138-146. doi: 10.1016/j.breast.2021.09.011. Epub 2021 Oct 1.

ReferenceCitation: Carausu M, Carton M, Darlix A, Pasquier D, Leheurteur M, Debled M, Mouret-Reynier MA, Goncalves A, Dalenc F, Verret B, Campone M, Augereau P, Ferrero JM, Levy C, Fumet JD, Lefeuvre-Plesse C, Petit T, Uwer L, Jouannaud C, Larrouquere L, Chevrot M, Courtinard C, Cabel L. Breast cancer patients treated with intrathecal therapy for leptomeningeal metastases in a large real-life database. ESMO Open. 2021 Jun;6(3):100150. doi: 10.1016/j.esmoop.2021.100150. Epub 2021 May 10.

ReferenceCitation: Corbaux P, Lardy-Cleaud A, Alexandre M, Fontanilles M, Lévy C, Viansone AA, Mailliez A, Debled M, Goncalves A, Le Du F, Lerebours F, Ferrero JM, Eymard JC, Mouret-Reynier MA, Petit T, Frenel JS, Dalenc F, Courtinard C, Chaix M, Bachelot T. Progression-free survival on endocrine therapy, before or after chemotherapy, in hormone receptor-positive HER2-negative metastatic breast cancer. Breast Cancer Res Treat. 2022 Jan;191(1):191-207. doi: 10.1007/s10549-021-06382-6. Epub 2021 Oct 23.

ReferenceCitation: Dano D, Lardy-Cleaud A, Monneur A, Quenel-Tueux N, Levy C, Mouret-Reynier MA, Coudert B, Mailliez A, Ferrero JM, Guiu S, Campone M, de La Motte Rouge T, Petit T, Pistilli B, Dalenc F, Simon G, Lerebours F, Chabaud S, Bertucci F, Gonçalves A. Metastatic inflammatory breast cancer: survival outcomes and prognostic factors in the national, multicentric, and real-life French cohort (ESME). ESMO Open. 2021 Aug;6(4):100220. doi: 10.1016/j.esmoop.2021.100220. Epub 2021 Jul 22.

ReferenceCitation: Ezzalfani M, Porcher R, Savignoni A, Delaloge S, Filleron T, Robain M, Pérol D; ESME Group. Addressing the issue of bias in observational studies: Using instrumental variables and a quasi-randomization trial in an ESME research project. PLoS One. 2021 Sep 15;16(9):e0255017. doi: 10.1371/journal.pone.0255017. eCollection 2021.

ReferenceCitation: Gaillard T, Carton M, Mailliez A, Desmoulins I, Mouret-Reynier MA, Petit T, Leheurteur M, Dieras V, Ferrero JM, Uwer L, Guiu S, Gonçalves A, Levy C, Debled M, Dalenc F, Patsouris A, Bachelot T, Eymard JC, Chevrot M, Conversano A, Robain M, Hequet D. De novo metastatic breast cancer in patients with a small locoregional tumour (T1-T2/N0): Characteristics and prognosis. Eur J Cancer. 2021 Oct 21;158:181-188. doi: 10.1016/j.ejca.2021.09.021. [Epub ahead of print] Erratum in: Eur J Cancer. 2022 May;166:311-312.

ReferenceCitation: Grinda T, Antoine A, Jacot W, Blaye C, Cottu PH, Diéras V, Dalenc F, Gonçalves A, Debled M, Patsouris A, Mouret-Reynier MA, Mailliez A, Clatot F, Levy C, Ferrero JM, Desmoulins I, Uwer L, Petit T, Jouannaud C, Lacroix-Triki M, Deluche E, Robain M, Courtinard C, Bachelot T, Brain E, Pérol D, Delaloge S. Evolution of overall survival and receipt of new therapies by subtype among 20 446 metastatic breast cancer patients in the 2008-2017 ESME cohort. ESMO Open. 2021 Jun;6(3):100114. doi: 10.1016/j.esmoop.2021.100114. Epub 2021 Apr 23.

ReferenceCitation: Grinda T, Joyon N, Lusque A, Lefèvre S, Arnould L, Penault-Llorca F, Macgrogan G, Treilleux I, Vincent-Salomon A, Haudebourg J, Maran-Gonzalez A, Charafe-Jauffret E, Courtinard C, Franchet C, Verriele V, Brain E, Tas P, Blanc-Fournier C, Leroux A, Loussouarn D, Berghian A, Brabencova E, Ghnassia JP, Scoazec JY, Delaloge S, Filleron T, Lacroix-Triki M. Phenotypic discordance between primary and metastatic breast cancer in the large-scale real-life multicenter French ESME cohort. NPJ Breast Cancer. 2021 Apr 16;7(1):41. doi: 10.1038/s41523-021-00252-6.

ReferenceCitation: Bringuier M, Carton M, Levy C, Patsouris A, Pasquier D, Debled M, Rigal O, Jacot W, Gonçalves A, Desmoulins I, De La Motte Rouge T, Bachelot T, Ferrero JM, Eymard JC, Ung M, Mouret-Reynier MA, Petit T, Chevrot M, Uwer L, Courtinard C, Frenel JS, Vianzone A, Baldini C. Enrollment of older metastatic breast cancer patients in first-line clinical trials: 9-year experience of the large-scale real-life multicenter French ESME cohort. Breast Cancer Res Treat. 2022 Feb;191(3):577-587. doi: 10.1007/s10549-021-06467-2. Epub 2022 Jan 5.

ReferenceCitation: Carausu M, Carton M, Cabel L, Patsouris A, Levy C, Verret B, Pasquier D, Debled M, Gonçalves A, Desmoulins I, Lecouillard I, Bachelot T, Ferrero JM, Eymard JC, Mouret-Reynier MA, Chevrot M, De Maio E, Uwer L, Frenel JS, Leheurteur M, Petit T, Darlix A, Bozec L. Clinicopathological characteristics and prognosis of breast cancer patients with isolated central nervous system metastases in the multicentre ESME database. Ther Adv Med Oncol. 2022 Feb 26;14:17588359221077082. doi: 10.1177/17588359221077082. eCollection 2022.

ReferenceCitation: Dalenc F, Lusque A, De La Motte Rouge T, Pistilli B, Brain E, Pasquier D, Debled M, Thery JC, Gonçalves A, Desmoulins I, Levy C, Uwer L, Ferrero JM, Eymard JC, Mouret-Reynier MA, Patsouris A, Frenel JS, Petit T, Chevrot M, Bachelot T, Guiu S. Impact of lobular versus ductal histology on overall survival in metastatic breast cancer: a French retrospective multicentre cohort study. Eur J Cancer. 2022 Mar;164:70-79. doi: 10.1016/j.ejca.2021.12.031. Epub 2022 Feb 14.

ReferenceCitation: Mallet A, Lusque A, Levy C, Pistilli B, Brain E, Pasquier D, Debled M, Thery JC, Gonçalves A, Desmoulins I, De La Motte Rouge T, Faure C, Ferrero JM, Eymard JC, Mouret-Reynier MA, Patsouris A, Cottu P, Dalenc F, Petit T, Payen O, Uwer L, Guiu S, Frenel JS. Real-world evidence of the management and prognosis of young women (⩽40 years) with de novo metastatic breast cancer. Ther Adv Med Oncol. 2022 Jan 21;14:17588359211070362. doi: 10.1177/17588359211070362. eCollection 2022.

ReferenceCitation: Moinard-Butot F, Saint-Martin C, Pflumio C, Carton M, Jacot W, Cottu PH, Diéras V, Dalenc F, Goncalves A, Debled M, Patsouris A, Mouret-Reynier MA, Vanlemmens L, Leheurteur M, Emile G, Ferrero JM, Desmoulins I, Uwer L, Eymard JC, Cheaib B, Courtinard C, Bachelot T, Chevrot M, Petit T. Efficacy of trastuzumab emtansine (T-DM1) and lapatinib after dual HER2 inhibition with trastuzumab and pertuzumab in patient with metastatic breast cancer: Retrospective data from a French multicenter real-life cohort. Breast. 2022 Jun;63:54-60. doi: 10.1016/j.breast.2022.03.004. Epub 2022 Mar 11.

ReferenceCitation: Jacot W, Lusque A, Vicier C, Mailliez A, de La Motte Rouge T, Cabel L, Levy C, Patsouris A, Desmoulins I, Uwer L, Thery JC, Robain M, Caron O, Tredan O, Filleron T, Frenel JS, Delaloge S. Outcomes of patients with HER2-negative metastatic breast cancer after platinum- and non-platinum-based first-line chemotherapy among patients with and without pathogenic germline BRCA1/2 mutations. Br J Cancer. 2022 Oct 7. doi: 10.1038/s41416-022-02003-1. [Epub ahead of print]

location_facility: Institut régional du Cancer Montpellier / Val d'Aurelle

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

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


title: Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform : Evolution of the Therapeutic Care in Ovarian Cancer Across the French Comprehensive Cancer Centers From 2011

acronym: ESME-OVR

summary: The ESME OVR Data Platform is a multi-center real life database using a retrospective data collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites). This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.

ReferenceCitation: Romeo, C, P Meeus, M Rodrigues, E Leblanc, A Floquet, P Pautier, F Marchal, et al. " EP967 Natural history of patients with BRCA-mutated high grade epithelial ovarian cancer (HGEOC) before the era of PARP inhibitors maintenance in 1st line treatment ". In ePoster, A513.3-A513. BMJ Publishing Group Ltd, 2019. https://doi.org/10.1136/ijgc-2019-ESGO.1013.

ReferenceCitation: De Nonneville A, Zemmour C, Frank S, Joly F, Ray-Coquard I, Costaz H, Classe JM, Floquet A, De la Motte Rouge T, Colombo PE, Sauterey B, Leblanc E, Pomel C, Marchal F, Barranger E, Savoye AM, Guillemet C, Petit T, Pautier P, Rouzier R, Gladieff L, Simon G, Courtinard C, Sabatier R. Clinicopathological characterization of a real-world multicenter cohort of endometrioid ovarian carcinoma: Analysis of the French national ESME-Unicancer database. Gynecol Oncol. 2021 Oct;163(1):64-71. doi: 10.1016/j.ygyno.2021.07.019. Epub 2021 Jul 19.

ReferenceCitation: Rodrigues M, Joly F, Ray-Coquard I, Costaz H, Classe JM, Floquet A, De la Motte Rouge T, Colombo PE, Provensal Gross M, Leblac E, Pomel C, Marchal F, Barranger E, Savoye AM, Guillemet C, Petit T, Pautier P, Rouzier R, Courtinard C, Gladieff L. Real-world clinical outcomes of patients with de novo advanced high-grade epithelial ovarian cancer eligible to niraparib maintenance in France. ESMO Congress, September 16-21, 2021 [ePoster 746P] DOI:https://doi.org/10.1016/j.annonc.2021.08.1188

doi: rodrigues


title: Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery

acronym: MITRA-HR

summary:
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment strategy in patients with severe primary mitral regurgitation judged eligible for anatomical repair with the MitraClip® or mitral valve surgery with high surgical risk.

This trial is a French and Monegasque, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years ( clinical visit at 1 month, at 6 months and 12 months, phone call at 18 months and clincial visit at 24 months).

lead_sponsor: Nantes University Hospital

location_country: France Monaco

location_facility:
Institut Hospitalier Jacques Cartier
Hopital Prive Le Bois Lille
Clinique Saint Augustin
Hopital Bichat
CHU de Rouen
CHU LYON
Hopital Henri Mondor Aphp
Clinique Du Millenaire
Chru Brest
Chu Rennes
Institut Mutualiste Montsouris
Chru Tours
Clinique Du Tonkin
Chu Grenoble
Hopital Prive Clairval
Hopital Civil Strasbourg
Ch Annecy
Hopital Europeen Georges Pompidou
Hopital St Joseph
Chu Nantes
Centre Chirurgical Marie Lannelongue
Clinique Pasteur
Hopital La Timone
Chu Saint Etienne
Chru Lille
Chu Angers
Clinique de La Sauvegarde
Hopital Rangueil
Centre Cardio-Thoracique de Monaco
Chu Poitiers
Centre Cardiologique Du Nord
Chu Bordeaux
Hopital La Pitie Salpetriere


title: Inhaled Versus Intravenous Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department

acronym: CLIN-AEROMORPH

summary:
Prospective single-blind, multicenter, national, randomized, controlled trial in 15 Emergency Department to compare two ways of morphine titration. The eligible patient is included immediately after his arrival in the Emergency Department, after being questioned by the triage nurse about the presence and the intensity of pain, when the VAS is greater than 70 (or EN>7) and after written consent.

After installation into the examination room, patient is randomized in one of two parallel groups (stratified by sex and center using software) and receives one of the two treatments, either inhaled morphine + IV placebo or IV morphine+ inhaled placebo (control group).

In both groups, titration is defined by a dose of repeated boluses as long as the relief is not achieved (VAS> 30 or EN >3) and the criteria to stop titration are not met.

A 5 minutes time interval between the boluses is chosen. Each aerosol takes 5 minutes at a constant air flow, aerosol mask, plastic tubing and PVC transparent tank are used.

Thus patient receives a maximum of 3 aerosol (one aerosol every 10 minutes) and a maximum of 6 IV injections (one injection every 5 minutes) The stopping criteria, except pain relief, are linked to the occurrence of side effects and specific cares are described into the protocol (in case of severe ventilatory depression naloxone titration is provided). Exit criteria from the emergency room and from the hospital are defined. An information sheet is delivered.

ReferenceCitation: Lvovschi VE, Joly J, Lemaire N, Maignan M, Canavaggio P, Leroi AM, Tavolacci MP, Joly LM. Nebulized versus intravenous morphine titration for the initial treatment of severe acute pain in the emergency department: study protocol for a multicenter, prospective randomized and controlled trial, CLIN-AEROMORPH. Trials. 2019 Apr 11;20(1):209. doi: 10.1186/s13063-019-3326-3.

lead_sponsor: University Hospital, Rouen

location_facility:
CHU de Caen
Chu Strasbourg
CHU Hôpitaux BORDEAUX
CH Le Mans
CH Agen-Nérac
Hopital COCHIN
CHU Grenoble
La Pitié Salpétrière
CHU-Hôpitaux de Rouen
GH Le Havre
CHU Nice
chu de Toulouse
CH Eure Seine Hôpital d'Evreux
CHU Gabriel Montpied
CHI Robert Ballanger
CHRU de Lille
Hôpital Lariboisière
Hospices civils de Lyon
Hôpital Bichat-Claude Bernard

intervention_type: Device