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: Service des Maladies Infectieuses et Tropicales - Hôpital Gabriel Montpied

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

location_facility: Service des Maladies Infectieuses - Hôpital Saint-Louis

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

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpital Purpan

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

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

location_facility: Service des Maladies Infectieuses - Hôpital Saint Antoine

location_facility: Service de Pneumologie - Hôpital St Joseph

location_facility: Service de Dermatologie - Hôpital l'Archet

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

location_facility: Service d'hématologie - Hôpital Gabriel Montpied

location_facility: Service de Cancérologie Médicale - Hôpital européen Georges Pompidou

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpital Tenon

location_facility: Service de Médecine interne - Hôpital Antoine Béclère

location_facility: Service de Médecine interne - Centre Hospitalier Intercommunal

location_facility: Service Hémopathies Lymphoïdes - Hôpital Henri Mondor

location_facility: Service d'Immunologie - Hôpital Felix Guyon

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

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

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

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Service d'Immunologie Clinique - Hôpital Henri Mondor

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

location_facility: Service de pneumologie - Hôpital Victor Dupouy

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

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

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

location_facility: Servide de Dermatologie - Hôpital Saint-Louis

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service Oncologie Hématologie - Hôpital Yves Le Foll

location_facility: Service Oncologie Médicale - Centre Hospitalier Intercommunal

location_facility: Service de pneumologie - Centre Hospitalier Intercommunal

location_facility: Service de Médecine Interne - Centre Hospitalier de Martigues

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

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

location_facility: Pôle de Médecine 2 - Centre Hospitalier Andrée Rosemon

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

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

location_facility: Service de Médecine Interne - Hôpital Foch

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

location_facility: Service Hématologie Clinique - Hôpital Pitié-Salpêtrière

location_facility: Service de pneumologie - Hôpital Yves Le Foll

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

location_facility: Service dermatologie/vénéréologie - Hôpital de la Timone

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

location_facility: Service de dermatologie - Hôpital St Joseph

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

location_facility: Ambulatoire-Hôpital de Jour - Institut Paoli Calmettes

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

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

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

location_facility: Service d'oncologie multidiscliplinaire - Hôpital Nord

intervention_type: Biological


type: Other Identifier

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.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Rennes University Hospital

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

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


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.

status: Unknown status

primary_purpose: Other

enrollment_type: Anticipated

ReferenceType: derived

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.

family: Landais

full_name: Mickael Landais

given: Mickael

sequence: first

family: Nay

full_name: Mai-Anh Nay

given: Mai-Anh

sequence: additional

family: Auchabie

full_name: Johann Auchabie

given: Johann

family: Hubert

full_name: Noemie Hubert

given: Noemie

family: Rebion

full_name: Anne Rebion

given: Anne

family: Robert

full_name: Alain Robert

given: Alain

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

family: Reignier

full_name: Jean Reignier

given: Jean

family: Thille

full_name: Arnaud W Thille

given: Arnaud W

family: Tavernier

full_name: Elsa Tavernier

given: Elsa

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier le Mans

location_facility: Médecine Intensive Réanimation-CH ORLEANS

location_facility: Réanimation polyvalente-CHG SAINT NAZAIRE

location_facility: Réanimation et Soins Continus-CHI de CORNOUAILLE

location_facility: Réanimation médico-chirurgicale-CH PARIS ST JOSEPH

location_facility: Réanimation polyvalente-Centre Hospitalier Départemental Vendée

location_facility: Réanimation médico-chirurgicale- CH LE MANS

intervention_type: Other

status_simplified: Unknown


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.

status: Recruiting

lead_sponsor: UNICANCER

location_facility: Gustave Roussy Cancer Campus Grand Paris

location_facility: Institut de Cancérologie Lucien Neuwirth

intervention_type: Radiation

lead_sponsor_type: industriel


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.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

lead_sponsor: Hospices Civils de Lyon

location_country: France Mayotte

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

status_simplified: Completed


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 Dupuytren

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire Poitiers

location_facility: Centre Hospitalier Universitaire Bordeaux

location_facility: Centre Hospitalier René Dubois - Pontoise

location_facility: Centre Hospitalier Universitaire Saint Etienne

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire G. Montpied

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire Lapeyronie

location_facility: Centre Hospitalier Universitaire Strasbourg


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

design_allocation: Non-Randomized

lead_sponsor: Octapharma

location_facility: Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle

location_facility: Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou

location_facility: Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau

location_facility: Centre Hospitalier Universitaire de Nantes Hôtel-Dieu

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

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

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

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

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 Strasbourg Nouvel Hôpital Civil Service des Urgences

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

location_facility: Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz

location_facility: Centre Hospitalier Chalon-sur-Saône William Morey

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

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

location_facility: Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche

location_facility: Centre Hospitalier Régional Metz-Thionville Hôpital Mercy


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.

time_perspective: Retrospective

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

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.

ipd_sharing: No

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

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


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.

family: Bréhier

full_name: Germain Bréhier

given: Germain

family: Bouvier

full_name: Antoine Bouvier

given: Antoine

family: Besnier

full_name: Louis Besnier

given: Louis

family: Willoteaux

full_name: Serge Willoteaux

given: Serge

family: Nedelcu

full_name: Cosmina Nedelcu

given: Cosmina

family: Culty

full_name: Thibaut Culty

given: Thibaut

family: Aubé

full_name: Christophe Aubé

given: Christophe

family: Bigot

full_name: Pierre Bigot

given: Pierre

currency_apc_doaj: USD

journal_name: Scientific Reports

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Européen Georges Pompidou - APHP

intervention_type: Procedure


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


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 Grenoble - Hôpital Nord Michallon

location_facility: CH de Saint Brieuc - Hôpital Yves Le Foll

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied


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: 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: background

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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: 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: 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]

ReferenceType: result

ReferenceCitation: Delaloge S, Pérol D, Courtinard C, Brain E, Asselain B, Bachelot T, Debled M, Dieras V, Campone M, Levy C, Jacot W, Lorgis V, Veyret C, Dalenc F, Ferrero JM, Uwer L, Kerbrat P, Goncalves A, Mouret-Reynier MA, Petit T, Jouannaud C, Vanlemmens L, Chenuc G, Guesmia T, Robain M, Cailliot C. Paclitaxel plus bevacizumab or paclitaxel as first-line treatment for HER2-negative metastatic breast cancer in a multicenter national observational study. Ann Oncol. 2016 Sep;27(9):1725-32. doi: 10.1093/annonc/mdw260. Epub 2016 Jul 19.

family: Delaloge

full_name: S. Delaloge

given: S.

family: Pérol

full_name: D. Pérol

given: D.

family: Courtinard

full_name: C. Courtinard

given: C.

family: Brain

full_name: E. Brain

given: E.

family: Asselain

full_name: B. Asselain

given: B.

family: Bachelot

full_name: T. Bachelot

given: T.

family: Debled

full_name: M. Debled

given: M.

family: Dieras

full_name: V. Dieras

given: V.

family: Campone

full_name: M. Campone

family: Levy

full_name: C. Levy

family: Jacot

full_name: W. Jacot

given: W.

family: Lorgis

full_name: V. Lorgis

family: Veyret

full_name: C. Veyret

family: Dalenc

full_name: F. Dalenc

given: F.

family: Ferrero

full_name: J.M. Ferrero

family: Uwer

full_name: L. Uwer

given: L.

family: Kerbrat

full_name: P. Kerbrat

given: P.

family: Goncalves

full_name: A. Goncalves

given: A.

family: Mouret-Reynier

full_name: M.A. Mouret-Reynier

family: Petit

full_name: T. Petit

family: Jouannaud

full_name: C. Jouannaud

family: Vanlemmens

full_name: L. Vanlemmens

ReferenceCitation: Jacquet E, Lardy-Cléaud A, Pistilli B, Franck S, Cottu P, Delaloge S, Debled M, Vanlemmens L, Leheurteur M, Guizard AV, Laborde L, Uwer L, Jacot W, Berchery D, Desmoulins I, Ferrero JM, Perrocheau G, Courtinard C, Brain E, Chabaud S, Robain M, Bachelot T. Endocrine therapy or chemotherapy as first-line therapy in hormone receptor-positive HER2-negative metastatic breast cancer patients. Eur J Cancer. 2018 May;95:93-101. doi: 10.1016/j.ejca.2018.03.013. Epub 2018 Apr 11.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

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

title: Endocrine therapy or chemotherapy as first-line therapy in hormone receptor–positive HER2-negative metastatic breast cancer patients

ReferenceCitation: Gobbini E, Ezzalfani M, Dieras V, Bachelot T, 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, Cleaud AL, Robain M, Courtinard C, Cailliot C, Perol D, Delaloge S. Time trends of overall survival among metastatic breast cancer patients in the real-life ESME cohort. Eur J Cancer. 2018 Jun;96:17-24. doi: 10.1016/j.ejca.2018.03.015. Epub 2018 Apr 13.

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.

ReferenceCitation: Delaloge S, Pérol D, Robain M, Cailliot C. Reply to 'The potential and perils of observational studies' by M. Buyse et al. Ann Oncol. 2017 Feb 1;28(2):436-437. doi: 10.1093/annonc/mdw572.

title: Reply to ‘The potential and perils of observational studies’ by M. Buyse et al.

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.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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.

name: Institut du Cancer de Montpellier (ICM) Val d'AurelleMontpellier University Montpellier France

name: Institut Claudius RegaudIUCT‐Oncopole Toulouse France

name: Institut de Cancérologie de l'Ouest Saint‐Herblain France

name: Centre Georges Francois Leclerc Dijon France

name: Institut Paoli‐Calmettes Marseille France

name: Institut de Cancérologie de Lorraine Vandœuvre‐lès‐Nancy France

name: Institut de Cancérologie Jean Godinot Reims France

name: Centre Jean‐Perrin Clermont‐Ferrand France

name: Etablissement Hospitalier Institut Curie Paris France

title: Real‐life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program

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.

title: Assessment of the efficacy of successive endocrine therapies in hormone receptor–positive and HER2-negative metastatic breast cancer: a real-life multicentre national study

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: 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.

title: Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008–2016

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.

title: Palliative care delivery according to age in 12,000 women with metastatic breast cancer: Analysis in the multicentre ESME-MBC cohort 2008–2016

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: 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.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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.

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

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

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

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

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


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.

family: De Nonneville

full_name: Alexandre De Nonneville

given: Alexandre

family: Zemmour

full_name: Christophe Zemmour

family: Frank

full_name: Sophie Frank

given: Sophie

family: Joly

full_name: Florence Joly

given: Florence

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Costaz

full_name: Hèlène Costaz

given: Hèlène

family: Classe

full_name: Jean-Marc Classe

given: Jean-Marc

family: Floquet

full_name: Anne Floquet

given: Anne

family: De la Motte Rouge

full_name: Thibault De la Motte Rouge

given: Thibault

family: Colombo

full_name: Pierre-Emmanuel Colombo

given: Pierre-Emmanuel

family: Sauterey

full_name: Baptiste Sauterey

given: Baptiste

family: Leblanc

full_name: Eric Leblanc

given: Eric

family: Pomel

full_name: Christophe Pomel

family: Marchal

full_name: Frédéric Marchal

given: Frédéric

family: Barranger

full_name: Emmanuel Barranger

given: Emmanuel

family: Savoye

full_name: Aude-Marie Savoye

given: Aude-Marie

family: Guillemet

full_name: Cécile Guillemet

given: Cécile

full_name: Thierry Petit

given: Thierry

family: Pautier

full_name: Patricia Pautier

given: Patricia

family: Rouzier

full_name: Roman Rouzier

given: Roman

family: Gladieff

full_name: Laurence Gladieff

given: Laurence

family: Simon

full_name: Gaëtane Simon

given: Gaëtane

family: Courtinard

full_name: Coralie Courtinard

given: Coralie

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


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: Monaco France

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

intervention_type: Device


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.

family: Lvovschi

full_name: Virginie Eve Lvovschi

given: Virginie Eve

family: Joly

full_name: Justine Joly

given: Justine

family: Lemaire

full_name: Nicolas Lemaire

given: Nicolas

family: Maignan

full_name: Maxime Maignan

given: Maxime

family: Canavaggio

full_name: Pauline Canavaggio

given: Pauline

family: Leroi

full_name: Anne-Marie Leroi

given: Anne-Marie

family: Tavolacci

full_name: Marie-Pierre Tavolacci

given: Marie-Pierre

full_name: Luc-Marie Joly

given: Luc-Marie

journal_name: Trials

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

lead_sponsor: University Hospital, Rouen

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


lead_sponsor: Versailles Hospital

acronym: EWALL-INO

location_facility:
Hopital Necker
CH Roubaix
CHU Strasbourg
Hopital Duchenne
CH Amiens sud
Centre H Becquerel Rouen
CH Versailles
CHU Nantes
Centre Leon Berard
Hopital Avicenne
Hopital St Antoine
CH Valenciennes
Hopital St Louis
CH Montpellier
CHU Limoges
CHRU Nancy
Hopital Dijon
CH Meaux
CHU Besançon
IPC
Hopital Mondor
CH Reims
CH Lyon Sud
CHU Angers
CHU Haut Leveque
HIA Percy
Institut de cancerologie
CHU Caen
CHR Orléans
Centre Lacassagne
IUCT Oncopole
CHU Clermond Ferrand
CHU Grenoble
CHU Nice
CH metropole Savois_ chambery

type: EudraCT Number

source: euctr

title: A Phase 2 Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients With Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia

summary: The aim of the present EWALL-INO study is to confirm very promising results obtained with a combination of INO and mild chemotherapy in older de novo CD22+ B-ALL patients. For that purpose, safety and efficacy of a weekly INO administration combined to mild-intensity chemotherapy will be evaluated in a cohort of patients aged more than 55 years with newly diagnosed previously untreated Ph-negative (CD22+) BCP-ALL. Conversely to the MDACC miniHCVD-INO study and in order to lower the overall toxicity of the combination, INO will be given as part of the remission induction treatment phase during the first 2 treatment cycles only, in combination with corticosteroid, vincristine, cyclophosphamide and intrathecal prophylaxis only; then, all responding patients will received standard INO-free chemotherapy as consolidation and maintenance.


title: ANRS CO1 EPF Prospective Observational Cohort Study on Mother-to-child Transmission HIV1 and/or HIV2 and Prevention

acronym: EPF

summary: The purpose of this study is to describe over time the rate of mother to child transmission of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV

ReferenceCitation: Mandelbrot L, Tubiana R, Le Chenadec J, Dollfus C, Faye A, Pannier E, Matheron S, Khuong MA, Garrait V, Reliquet V, Devidas A, Berrebi A, Allisy C, Elleau C, Arvieux C, Rouzioux C, Warszawski J, Blanche S; ANRS-EPF Study Group. No perinatal HIV-1 transmission from women with effective antiretroviral therapy starting before conception. Clin Infect Dis. 2015 Dec 1;61(11):1715-25. doi: 10.1093/cid/civ578. Epub 2015 Jul 21.

family: Mandelbrot

full_name: Laurent Mandelbrot

given: Laurent

family: Tubiana

full_name: Roland Tubiana

given: Roland

family: Le Chenadec

full_name: Jerome Le Chenadec

given: Jerome

family: Dollfus

full_name: Catherine Dollfus

given: Catherine

family: Faye

full_name: Albert Faye

given: Albert

family: Pannier

full_name: Emmanuelle Pannier

given: Emmanuelle

family: Matheron

full_name: Sophie Matheron

given: Sophie

family: Khuong

full_name: Marie-Aude Khuong

given: Marie-Aude

family: Garrait

full_name: Valerie Garrait

given: Valerie

family: Reliquet

full_name: Veronique Reliquet

given: Veronique

family: Devidas

full_name: Alain Devidas

given: Alain

family: Berrebi

full_name: Alain Berrebi

family: Allisy

full_name: Christine Allisy

given: Christine

family: Elleau

full_name: Christophe Elleau

given: Christophe

family: Arvieux

full_name: Cedric Arvieux

given: Cedric

family: Rouzioux

full_name: Christine Rouzioux

family: Warszawski

full_name: Josiane Warszawski

given: Josiane

family: Blanche

full_name: Stéphane Blanche

given: Stéphane

journal_name: Clinical Infectious Diseases

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: No Perinatal HIV-1 Transmission From Women With Effective Antiretroviral Therapy Starting Before Conception

ReferenceCitation: Taron-Brocard C, Le Chenadec J, Faye A, Dollfus C, Goetghebuer T, Gajdos V, Labaune JM, Perilhou A, Mandelbrot L, Blanche S, Warszawski J; France REcherche Nord&Sud Sida-HIV Hepatites - Enquete Perinatale Francaise - CO1/CO11 Study Group. Increased risk of serious bacterial infections due to maternal immunosuppression in HIV-exposed uninfected infants in a European country. Clin Infect Dis. 2014 Nov 1;59(9):1332-45. doi: 10.1093/cid/ciu586. Epub 2014 Jul 22.

family: Taron-Brocard

full_name: C. Taron-Brocard

given: C.

full_name: J. Le Chenadec

name: for the France REcherche Nord&Sud Sida-HIV Hepatites - Enquete Perinatale Francaise - CO1/CO11 Study Group

title: Increased Risk of Serious Bacterial Infections Due to Maternal Immunosuppression in HIV-Exposed Uninfected Infants in a European Country

ReferenceCitation: Sibiude J, Mandelbrot L, Blanche S, Le Chenadec J, Boullag-Bonnet N, Faye A, Dollfus C, Tubiana R, Bonnet D, Lelong N, Khoshnood B, Warszawski J. Association between prenatal exposure to antiretroviral therapy and birth defects: an analysis of the French perinatal cohort study (ANRS CO1/CO11). PLoS Med. 2014 Apr 29;11(4):e1001635. doi: 10.1371/journal.pmed.1001635. eCollection 2014 Apr.

title: Association between Prenatal Exposure to Antiretroviral Therapy and Birth Defects: An Analysis of the French Perinatal Cohort Study (ANRS CO1/CO11)

ReferenceCitation: Briand N, Jasseron C, Sibiude J, Azria E, Pollet J, Hammou Y, Warszawski J, Mandelbrot L. Cesarean section for HIV-infected women in the combination antiretroviral therapies era, 2000-2010. Am J Obstet Gynecol. 2013 Oct;209(4):335.e1-335.e12. doi: 10.1016/j.ajog.2013.06.021. Epub 2013 Jun 18.

journal_name: American Journal of Obstetrics and Gynecology

title: Cesarean section for HIV-infected women in the combination antiretroviral therapies era, 2000–2010

ReferenceCitation: Briand N, Warszawski J, Mandelbrot L, Dollfus C, Pannier E, Cravello L, Nguyen R, Matheron I, Winer N, Tubiana R, Rouzioux C, Faye A, Blanche S; ANRS-EPF CO1-CO11 Study Group. Is intrapartum intravenous zidovudine for prevention of mother-to-child HIV-1 transmission still useful in the combination antiretroviral therapy era? Clin Infect Dis. 2013 Sep;57(6):903-14. doi: 10.1093/cid/cit374. Epub 2013 May 31.

title: Is Intrapartum Intravenous Zidovudine for Prevention of Mother-to-Child HIV-1 Transmission Still Useful in the Combination Antiretroviral Therapy Era?

ReferenceCitation: Rachas A, Warszawski J, Le Chenadec J, Legeai C, Teglas JP, Goujard C, Rouzioux C, Mandelbrot L, Tubiana R, Meyer L. Does pregnancy affect the early response to cART? AIDS. 2013 Jan 28;27(3):357-67. doi: 10.1097/QAD.0b013e32835ac8bc.

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Jasseron C, Mandelbrot L, Dollfus C, Trocmé N, Tubiana R, Teglas JP, Faye A, Rouzioux C, Blanche S, Warszawski J. Non-disclosure of a pregnant woman's HIV status to her partner is associated with non-optimal prevention of mother-to-child transmission. AIDS Behav. 2013 Feb;17(2):488-97. doi: 10.1007/s10461-011-0084-y.

title: Non-Disclosure of a Pregnant Woman’s HIV Status to Her Partner is Associated with Non-Optimal Prevention of Mother-to-Child Transmission

ReferenceCitation: Simon A, Warszawski J, Kariyawasam D, Le Chenadec J, Benhammou V, Czernichow P, Foissac F, Laborde K, Tréluyer JM, Firtion G, Layouni I, Munzer M, Bavoux F, Polak M, Blanche S; ANRS French Perinatal Cohort Study Group. Association of prenatal and postnatal exposure to lopinavir-ritonavir and adrenal dysfunction among uninfected infants of HIV-infected mothers. JAMA. 2011 Jul 6;306(1):70-8. doi: 10.1001/jama.2011.915.

full_name: for the ANRS French Perinatal Cohort Study Group

title: Association of Prenatal and Postnatal Exposure to Lopinavir-Ritonavir and Adrenal Dysfunction Among Uninfected Infants of HIV-Infected Mothers

ReferenceCitation: Sibiude J, Warszawski J, Tubiana R, Dollfus C, Faye A, Rouzioux C, Teglas JP, Ekoukou D, Blanche S, Mandelbrot L. Premature delivery in HIV-infected women starting protease inhibitor therapy during pregnancy: role of the ritonavir boost? Clin Infect Dis. 2012 May;54(9):1348-60. doi: 10.1093/cid/cis198. Epub 2012 Mar 28.

title: Premature Delivery in HIV-Infected Women Starting Protease Inhibitor Therapy During Pregnancy: Role of the Ritonavir Boost?

ReferenceCitation: Tubiana R, Le Chenadec J, Rouzioux C, Mandelbrot L, Hamrene K, Dollfus C, Faye A, Delaugerre C, Blanche S, Warszawski J. Factors associated with mother-to-child transmission of HIV-1 despite a maternal viral load <500 copies/ml at delivery: a case-control study nested in the French perinatal cohort (EPF-ANRS CO1). Clin Infect Dis. 2010 Feb 15;50(4):585-96. doi: 10.1086/650005.

title: Factors Associated with Mother‐to‐Child Transmission of HIV‐1 Despite a Maternal Viral Load <500 Copies/mL at Delivery: A Case‐Control Study Nested in the French Perinatal Cohort (EPF‐ANRS CO1)

ReferenceCitation: Briand N, Mandelbrot L, Le Chenadec J, Tubiana R, Teglas JP, Faye A, Dollfus C, Rouzioux C, Blanche S, Warszawski J; ANRS French Perinatal Cohort. No relation between in-utero exposure to HAART and intrauterine growth retardation. AIDS. 2009 Jun 19;23(10):1235-43. doi: 10.1097/QAD.0b013e32832be0df.

ReferenceCitation: Mandelbrot L, Jasseron C, Ekoukou D, Batallan A, Bongain A, Pannier E, Blanche S, Tubiana R, Rouzioux C, Warszawski J; ANRS French Perinatal Cohort (EPF). Amniocentesis and mother-to-child human immunodeficiency virus transmission in the Agence Nationale de Recherches sur le SIDA et les Hépatites Virales French Perinatal Cohort. Am J Obstet Gynecol. 2009 Feb;200(2):160.e1-9. doi: 10.1016/j.ajog.2008.08.049. Epub 2008 Nov 4.

ReferenceCitation: Jasseron C, Mandelbrot L, Tubiana R, Teglas JP, Faye A, Dollfus C, Le Chenadec J, Rouzioux C, Blanche S, Warszawski J; ANRS French Perinatal Cohort. Prevention of mother-to-child HIV transmission: similar access for sub-Sahara African immigrants and for French women? AIDS. 2008 Jul 31;22(12):1503-11. doi: 10.1097/QAD.0b013e3283065b8c.

ReferenceCitation: Benhammou V, Warszawski J, Bellec S, Doz F, André N, Lacour B, Levine M, Bavoux F, Tubiana R, Mandelbrot L, Clavel J, Blanche S; ANRS-Enquête Périnatale Française. Incidence of cancer in children perinatally exposed to nucleoside reverse transcriptase inhibitors. AIDS. 2008 Oct 18;22(16):2165-77. doi: 10.1097/QAD.0b013e328311d18b. Erratum in: AIDS. 2012 May 15;26(8):1047. Carbillon, François F [corrected to Carbillon, L].

ReferenceCitation: Warszawski J, Tubiana R, Le Chenadec J, Blanche S, Teglas JP, Dollfus C, Faye A, Burgard M, Rouzioux C, Mandelbrot L; ANRS French Perinatal Cohort. Mother-to-child HIV transmission despite antiretroviral therapy in the ANRS French Perinatal Cohort. AIDS. 2008 Jan 11;22(2):289-99.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Groupe Hospitalier Cochin Tarnier Port-Royal

location_facility: Centre Hospitalier Général- Hôpital Delafontaine


title: Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem

summary: This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis

lead_sponsor: Medacta International SA

location_facility:
Clinique de Saint Omer
Hôpital Jacques-Puel
Hôpital Castres
Nouvelle Clinique Bordeaux Tondu
Clinique d'Orange


title: Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee

acronym: USAK

summary:
Primary objective: Description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit.

Primary endpoint: Describe the ultrasound abnormalities observed on Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Poitiers University Hospital

location_facility:
CH de La roche-sur-yon
CHU de Nantes
CHU de Niort
CHU de Rennes
CH De La Rochelle


title: Explore the Associations of Behavioral Factors With Treatment Adherence in Axial Spondyloarthritis Patients Treated With Biotherapy

acronym: MAINTAIN II

summary: The management of chronic inflammatory rheumatism, including spondyloarthritis (SpA), has been revolutionized in recent decades with the arrival of biological therapy. The success of the current therapeutic strategy is also based on therapeutic compliance. If therapeutic adherence in rheumatoid arthritis patient (RA) is only 66%, it seems even worse in SpA. Few studies report quantitatively the adherence of SpA patients, as well as the predictive or associated factors. The objective of this study is to assess the patient adherence to biologics in patients with axial SpA (SpAax), and to investigate factors influencing this adherence, in particular the association with vaccination coverage, dietary behavior, and digital health tools.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU Limoges
CHU Clermont-Ferrand
Chu Toulouse
CHU Montpellier
CHU Bordeaux

intervention_type: Behavioral


title: Evaluation of Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.

acronym: RETRACT

summary:
The study design is a prospective, multi-center randomized, controlled, open label, 3-arm parallel group, post market clinical follow-up (PMCF) Clinical Trial.

The aim of the study is to collect clinical performance and safety data from RACEGEL and RACESTYPTINE Solution. Three gingival retraction techniques are being studied: RACESTYPTINE Solution with cord, RACEGEL with cord and RACEGEL without cord.

The study will demonstrate the expected performance of these 3 techniques in terms of sulcus opening, i.e. a lateral gingival displacement of at least 200 µm (state of the art) allowing the realization of pre-prosthetic impression with subgingivally margins. 90 subjects (teeth) requiring a dental restoration with subgingival margins for placement of a fixed prosthesis will be enrolled in 3 groups (30 in each group). For each participant, two dental impressions are performed: one impression before the gingival retraction and one impression immediately after the gingival retraction. Both impressions are scanned with 3D dental scanner and images are superimposed before analysis of tissue displacement.

lead_sponsor: Septodont

location_facility:
Cabinet dentaire Magister
Cabinet dentaire
Cabinet dentaire Dr Rubin
Cabinet dentaire - Médipole 35


title: Descriptive Factors of Intimate Partner Violence on Women Related to "Incapacité Totale de Travail" : Multicenter Prospective Study

acronym: SWIFT

summary:
Intimate partner violence is a real public health problem, and affects all socio-cultural backgrounds It is defined by behavior within an intimate relationship that causes physical, psychological or sexual harm or suffering to the people in that relationship.

Several risk factors exist such as young age, low level of education, exposing to violence during childhood, pregnancy or addictions.

ReferenceCitation: Leppäkoski T, Paavilainen E, Astedt-Kurki P. Experiences of emergency care by the women exposed to acute physical intimate partner violence from the Finnish perspective. Int Emerg Nurs. 2011 Jan;19(1):27-36. doi: 10.1016/j.ienj.2010.02.006. Epub 2010 May 20.

ReferenceCitation: Saberi E, Eather N, Pascoe S, McFadzean ML, Doran F, Hutchinson M. Ready, willing and able? A survey of clinicians' perceptions about domestic violence screening in a regional hospital emergency department. Australas Emerg Nurs J. 2017 May;20(2):82-86. doi: 10.1016/j.aenj.2017.02.001. Epub 2017 Mar 6.

ReferenceCitation: López-Ossorio JJ, González Álvarez JL, Buquerín Pascual S, García LF, Buela-Casal G. Risk factors related to intimate partner violence police recidivism in Spain. Int J Clin Health Psychol. 2017 May-Aug;17(2):107-119. doi: 10.1016/j.ijchp.2016.12.001. Epub 2017 Jan 31.

ReferenceCitation: Lyons VH, Kernic MA, Rowhani-Rahbar A, Holt VL, Carone M. Use of multiple failure models in injury epidemiology: a case study of arrest and intimate partner violence recidivism in Seattle, WA. Inj Epidemiol. 2019 Aug 12;6:36. doi: 10.1186/s40621-019-0215-x. eCollection 2019.

ReferenceCitation: Choi AW, Lo BC, Wong JY, Lo RT, Chau PC, Wong JK, Lau CL, Kam CW. Clinical Features of Heterosexual Intimate Partner Violence Victims With Escalating Injury Severity. J Interpers Violence. 2021 Sep;36(17-18):8585-8605. doi: 10.1177/0886260519850539. Epub 2019 May 29.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility: Centre Hospitalier Régional d'Orléans (UMJ)


title: Awakening of the Control of the Ankle Dorsiflexors in the Post Stroke Hemiplegic Subject to Improve Walking Activity and Social Participation: Experimental Interventional Study

acronym: WAKE

summary: This study is a multi-center, interventional, experimental, prospective, controlled and randomized study. We propose a reeducation protocol based on an early over-solicitation of the ankle dorsiflexor muscles to promote their "awakening", limit the loss of strength associated with the functional loss and thus allow to reach a more effective walking activity. This should encourage social participation following discharge from the hospital. The main objective is to evaluate the impact of this 6 weeks program on walking speed.

lead_sponsor: University Hospital, Limoges

location_facility: University Institute of Rehabilitation Valmante Sud


title: Multicentre Observational Study Evaluating the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy, in Real Life Setting.

acronym: MESOIMMUNE

summary: The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy outside of a clinical trial in terms of efficacy and safety.

time_perspective: Other

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CH Cherbourg
CHI Créteil
CHU Lille
CHU Brest
CH Côte basque


title: Impact of an Artificial Intelligence Platform on Inappropriate Medication Use in Older Adults

acronym: PING

summary: Polypharmacy in the older adults is common and promotes the risk of drug interactions. The hypothesis evoked is that a virtual platform with artificial intelligence applied to the health, and in particular to the good use of the drug, could bring aids to the doctors them of the prescription of drugs. The main objective of this study is to evaluate the impact of geriatric use of the Synapse platform on the frequency of inappropriate medication prescriptions (STOPP criteria) in discharge orders for patients 65 years of age or older hospitalized in geriatric department.

primary_purpose: Health Services Research

location_facility: Centre Hospitalier de Libourne - Pôle Gériatrie


title: DECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)

summary: Cancer pain is a frequent symptom, reported by 20 to 70% of patients in any stage of the cancer disease : 60 to 70% in the advanced stage of the disease and 20 to 40% among the survivors. Among patients who report pain, 40% report undertreated pain. Strengthening Pain management in cancer is a specific objective of the French Cancer Plan. Providing patient education for cancer pain management is recommended since small to moderate efficacy of patient education on pain intensity and interference was found in all meta-analysis. An effect size comparable with some analgesic agents. However, recommendations suggest improvement in order to increase effectiveness and population reach of those interventions. The DECLIC EPRI intervention aim at addressing all the issues raised by patient education for cancer pain management. It was developed according to the framework of Michie's Behavior change wheel theory.

lead_sponsor: Institut Curie

location_facility: Institut de Cancérologie de l'Ouest Paul Papin

location_facility: GH Diaconesses Croix Saint Simon (GHDCSS)


title: The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers

summary: The main objective is to show the impact on the quality of life (QoL) for adults patients with advanced cancer managed in day hospital of integrated palliative care of cancer center (HDJ-SPI).

primary_purpose: Supportive Care

ReferenceCitation: Thery L, Anota A, Waechter L, Laouisset C, Marchal T, Burnod A, Angellier E, Djoumakh OEK, Thebaut C, Brédart A, Dolbeault S, Mino JC, Bouleuc C. Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial. BMC Palliat Care. 2021 Apr 17;20(1):61. doi: 10.1186/s12904-021-00754-x.

family: Thery

full_name: Laura Thery

given: Laura

family: Anota

full_name: Amélie Anota

given: Amélie

family: Waechter

full_name: Lorraine Waechter

given: Lorraine

family: Laouisset

full_name: Celine Laouisset

given: Celine

family: Marchal

full_name: Timothee Marchal

given: Timothee

family: Burnod

full_name: Alexis Burnod

given: Alexis

family: Angellier

full_name: Elisabeth Angellier

given: Elisabeth

family: Djoumakh

full_name: Oum El Kheir Djoumakh

given: Oum El Kheir

family: Thebaut

full_name: Clemence Thebaut

given: Clemence

family: Brédart

full_name: Anne Brédart

given: Anne

family: Dolbeault

full_name: Sylvie Dolbeault

given: Sylvie

family: Mino

full_name: Jean-Christophe Mino

given: Jean-Christophe

family: Bouleuc

full_name: Carole Bouleuc

given: Carole

journal_name: BMC Palliative Care

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

location_facility:
Centre Antoine Lacassagne
INSTITUT CURIE Saint-Cloud
Institutcurie Paris
Centre Paul Strauss
Institut Bergonie


title: Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers

acronym: PREVADO

summary:
At the age of 17, in Brittany, 94.9% of adolescents have experimented alcohol consumption 78.1% within a month and 25.5% report repeated episodes of Intensive Punctual Alcohol. Among the potential explanatory factors of this worrying epidemiology, social and cultural factors induce a social valuation of alcohol consumption and drunkenness. There are also individual vulnerability factors, particularly important in adolescence between experimentation and the transition to regular use or even to alcohol use disorders. Despite the extent of the damage, there is currently little reliable data on effective primary prevention strategies for dealing with addictive behavior. Many prevention programs target age range in school settings, to delay or reduce use of psychoactive substances.

A meta-analysis on the impact of this prevention programs in school settings, concluded that most interventions are associated with no or little impact with respect to the goal of reducing psychoactive substances with teenagers.

Among existing programs, "PREVENTURE" has been evaluated in 5 trials with high-risk teenagers identified in schools settings, in different countries (Canada, Europe). The results show a clear and robust effect on reducing alcohol consumption. This program has not been tested outside the school setting and a recent review mention the need to make this program more accessible by targeting vulnerable groups and studying the impact of this program on this population.

The PREVADO study is a prospective, controlled, randomised, open-label study. After inclusion, the adolescent completes the questionnaire SURPS (Substance Use Risk Profile Scale).

The SURPS is self-report questionnaire that assesses four well-validated personality risk factors for substance misuse (Impulsivity, Sensation Seeking, Anxiety Sensitivity, and Hopelessness). There is a 23-item to which adolescents are asked to respond using a 4-point Likert scale ranging from "strongly agree" to "strongly disagree" : Hopelessness (7 items), Anxiety Sensitivity (5 items), Impulsivity (5 items), and Sensation Seeking (6 items).

Adolescents will be randomized into 2 groups (stratification on the 4 predominant risk personality types from the SURPS (Substance Use Risk Profile Scale) and on the recruitment modality) :

Intervention group : teenagers follow the "PREVENTURE" program and routine cares
Control group : teenagers follow routine cares

ReferenceCitation: Guillou-Landreat M, Tahmazov E, Benoit S, Grall-Bronnec M, Conrod P, Livet A, Nowak E, Le Reste J-. The efficacy of a targeted PREVENTION programme for addictive behaviour (PREVENTURE) among vulnerable ADOlescents in France - study procotol. BMC Public Health. 2021 Apr 23;21(1):783. doi: 10.1186/s12889-021-10795-9.

family: guillou-landreat

full_name: morgane guillou-landreat

given: morgane

family: Tahmazov

full_name: Elkhan Tahmazov

given: Elkhan

family: Benoit

full_name: Schreck Benoit

given: Schreck

family: Grall-bronnec

full_name: Marie Grall-bronnec

given: Marie

family: Conrod

full_name: Patricia Conrod

given: Patricia

family: Livet

full_name: Audrey Livet

given: Audrey

family: Nowak

full_name: Emmanuel Nowak

given: Emmanuel

family: Le Reste

full_name: Jean -Yves Le Reste

given: Jean -Yves

journal_name: BMC Public Health

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
Loik JOUSNI
Benoit SCHRECK
Catherine SIMON
Morgane GUILLOU - LANDREAT
Pascale ROZEC


title: Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range and Followed for 2 Years.

summary:
As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance with the approved instructions for use.

This study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.

lead_sponsor: FH ORTHO

location_facility:
Clinique Médipôle Garonne
Clinique du Pré
Clinique du Maine
Clinique de Saint Jean de Luz
Hôpitaux de Lannemezan


title: MGMT-NET: O6-methylguanine-DNA Methyltransferase (MGMT) Status in Neuroendocrine Tumors: Predictive Factor of Response to Alkylating Agents

acronym: MGMT-NET

summary:
Neuroendocrine tumors (NET) are rare but their incidence is growing. Alkylating agents (ALKY) are one of the main systemic treatments used, at least for advanced duodeno-pancreatic NETs, with a response rate of 30 to 40% and a median progression-free survival of 4 to 18 months. Chemotherapy is one of the few therapeutic weapons, along with everolimus, somatostatin analogs, and metabolic radiotherapy, for lung NETs, called typical and atypical carcinoids, even if the level of proof of efficacy for these treatments is lower than for duodeno-pancreatic NETs. Considering the available retrospective data, O6-Methylguanine-DNA methyltransferase (MGMT) appears to be a predictive factor of the response to ALKY. Oxaliplatin (OX) has demonstrated an interesting activity, with response rates between 17% and 30%. In a first retrospective study we showed that Gemox is effective in NET, and more recently that its activity is similar to that of ALKYs, but without being influenced by the MGMT status. Prospective studies are needed but our data suggests that ALKY should be offered first to patients with methylated MGMT tumors while Oxaliplatin-based chemotherapy should be offered first to patients with unmethylated MGMT tumors.

In this project, we wish to evaluate the contribution of the MGMT methylation, evaluated in the tumor, in predicting the Objective Response (OR) in patients treated with ALKY and to evaluate a treatment with alkylating agents versus Oxaliplatin in patients with a duodeno-pancreatic or lung or unknown primitive NET.

ReferenceCitation: Lemelin A, Barritault M, Hervieu V, Payen L, Péron J, Couvelard A, Cros J, Scoazec JY, Bin S, Villeneuve L, Lombard-Bohas C, Walter T; MGMT-NET investigators. O6-methylguanine-DNA methyltransferase (MGMT) status in neuroendocrine tumors: a randomized phase II study (MGMT-NET). Dig Liver Dis. 2019 Apr;51(4):595-599. doi: 10.1016/j.dld.2019.02.001. Epub 2019 Feb 14.

family: Lemelin

full_name: Annie Lemelin

given: Annie

family: Barritault

full_name: Marc Barritault

given: Marc

family: Hervieu

full_name: Valérie Hervieu

given: Valérie

family: Payen

full_name: Léa Payen

given: Léa

family: Péron

full_name: Julien Péron

given: Julien

family: Couvelard

full_name: Anne Couvelard

family: Cros

full_name: Jérome Cros

given: Jérome

family: Scoazec

full_name: Jean-Yves Scoazec

given: Jean-Yves

family: Bin

full_name: Sylvie Bin

family: Villeneuve

full_name: Laurent Villeneuve

given: Laurent

family: Lombard-Bohas

full_name: Catherine Lombard-Bohas

given: Catherine

family: Walter

full_name: Thomas Walter

given: Thomas

journal_name: Digestive and Liver Disease

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Estaing, CHU de Clermont-Ferrand

location_facility: Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Hôpital François Mitterrand - CHU Dijon Bourgogne


title: French National Database of Rare Dermatological Cancers: Merkel Cell Carcinoma, Inoperable or Metastatic Basal Cell Carcinoma, Cutaneous Adnexal Carcinomas

acronym: CARADERM

summary:
Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, and cutaneous adnexal carcinomas are 3 types of rare skin cancers for which much remains unknown in terms of natural behavior, prognosis, treatment and outcomes.

CARADERM is a French prospective national cohort enrolling patients with either one of these 3 tumor types, whose objectives are :

to provide epidemiological, clinical and socio-economic characteristics of patients
to identify new clinical or epidemiological prognostic factors for these rare cancers
to evaluate the impact of various treatments on outcomes

lead_sponsor: University Hospital, Lille

location_facility:
CHU de Toulouse - Larrey
CH Le Mans
CHU de Strasbourg
CHU de Tours
CHU de Rennes
CHU de Pointe à Pitre
CHU Bocage
CHU Nantes - Place Alexis Ricordeau
CHU Ambroise Paré
CHU Amiens Picardie
CHU de Nancy
CHU Bichat
CHU de Bordeaux
CHU Avicenne
CHU de Poitiers
CHU de Grenoble
CHR d'Orleans
CHU de Caen
CHU Cochin
CHU de Clermont Ferrand
CHU de Nice
CHU St Louis
CHU Besançon
CHU de Brest
CHU de Rouen
Institut Gustave Roussy
CHU Angers
Centre Léon Bérard
CHU de Reims
Hôpital La Timone
CHU de Limoges
Centre hospitalier Lyon Sud
CH Annecy Gennevois
Hôpital St Eloi


title: A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion

acronym: THEIA

summary: The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.

location_facility:
CH de Saint Nazaire
CHU de Strasbourg
CHU d'Angers
CH de La Rochelle
CHU de Tours
CHU de Montpellier
CH métropole Savoie
CHU de Rennes
CHU
CHU de Toulouse
CH Annecy Genevois
Fondation Ophtalmologique Rothschild
CHU de Bordeaux
CHU de Poitiers
Ch Perpignan
CH Vannes
CH d'Arras
CHU de Nantes
CHU de Nice
CHD Vendée
Vienne Hospital
CHU Caen
CHRU de Besançon
CHU Rouen


title: Multicenter Randomized Phase II Study Comparing the Effectiveness and Tolerance of Avelumab Versus Standard 2nd Line Treatment Chemotherapy in Patients With Colorectal Metastatic Cancer With Microsatellite Instability (MSI)

acronym: SAMCO

summary:
Immune chekpoints (ICI) are evaluated in many digestive cancers. Certain types of cancer appear to be rather refractory to ICI such as colorectal cancers (CRC). However, the MSI CRC representing approximately 15% of the CRCs exhibits a high mutational load which generates many potentially immunogenic neoantigens. In addition, strong expression of PD-L1 was found in the MSI CRCs relative to the CRC (MSS) stages. Localized MSI CRCs have a better prognosis than MSS CRCs, probably due to immunogenic neoantigens associated with a CD8 + T-specific immune response. On the oher hand, in metastatic CRC (mCRC) things are different because i) the MSI frequency is only 4 to 7% and ii) the good prognosis conferred by the MSI status is controversial.

Preliminary results suggest that patients with MSI mCRC are highly sensitive to ICI even chemoresistant tumors receiving several lines of chemotherapy. Recently, another anti-PD1 alone or in combination with an anti-CTLA4 (antigen associated with cytotoxic T-lymphocyte 4) was tested in the MSI CRCs and a selection of interesting results in heavily pretreated patients with a disease control rate of 56% for monotherapy and 81% for combinated therapy.

Anti-PD1s now have marketing authorization for patients with melanoma and metastatic pulmonary carcinoma , Which are known to have a high level of mutations . ICIs appear to be as promising in MSI CRCs as in other tumors and therefore face the same major challenges.

Avalumab is an anti-PD-L1 antibody recently tested in several different types of tumors with promising results and is currently being studied in phase III in gastric cancer. There is no data on the effectiveness of this ICI in the MSI mCRCs. In addition, only anti-PD1 was used in the MSI-mCRC and not the anti-PD-L1, and only in chemoresistance (3rd line or more). The main objective of the SAMCO study is to test the efficacy and tolerance of avelumab in the 2nd line of treatment in patients with a MSI mCRC progression after standard 1st line chemotherapy +/- targeted therapy.

ReferenceCitation: Taïeb J, André T, El Hajbi F, Barbier E, Toullec C, Kim S, Bouche O, Di Fiore F, Chauvenet M, Perrier H, Evesque L, Laurent-Puig P, Emile JF, Bez J, Lepage C, Tougeron D. Avelumab versus standard second line treatment chemotherapy in metastatic colorectal cancer patients with microsatellite instability: The SAMCO-PRODIGE 54 randomised phase II trial. Dig Liver Dis. 2021 Mar;53(3):318-323. doi: 10.1016/j.dld.2020.11.031. Epub 2020 Dec 25.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Privé - Cac- Centre Georges-Francois Leclerc

location_facility: Privé - Institut de Cancerologie de Lorraine

location_facility: Chu - Centre Hospitalier Universitaire Pontchaillou

location_facility: Ch - Centre Hospitalier de Charleville Mezieres

location_facility: Ch - Groupe Hospitalier Intercommunal Le Raincy

location_facility: Ch - Centre Hospitalier Docteur Schaffner

location_facility: Ch - Hopital Louis Pasteur - Oncologie Hematologie

location_facility: Privé - Clinique Mutualiste de L'Estuaire - Cite Sanitaire

location_facility: Privé - Centre de Radiotherapie Pierre Curie

location_facility: Ch - Centre Hospitalier Ardeche Meridionale

location_facility: Ch - Chic - Centre Hospitalier de Cornouaille

location_facility: Chr - Centre Hospitalier Régional de La Source

location_facility: Ch - Ghi de L'Est Francilien Site de Meaux

location_facility: Privé - Centre de Cancérologie Du Grand Montpellier

location_facility: Privé - Centre de Radiotherapie Et D'Oncologie Médicale de L'Essone

location_facility: Ch - Centre Hospitalier Metropole Savoie

location_facility: Ch - Centre Hospitalier de Montceau Les Mines

location_facility: Privé - Cac - Institut de Cancérologie de Strasbourg Europe

location_facility: Ch - Centre Hospitalier Marne La Vallee-Jossigny

location_facility: Privé - Institut de Cancerologie de Bourgogne Grrecc

location_facility: Chi - Centre Hospitalier de Castres Mazamet


title: Prévention Des Fausses Couches Spontanées Répétées Par Hydroxychloroquine. Essai thérapeutique Multicentrique, randomisé, en Double Insu, Contre Placebo

acronym: BBQ

summary:
Recurrent miscarriage (RM) defined by >=3 consecutive losses affects 1% of fertile couples. Most women have recurrent early loss with a failure of development before 10 weeks' gestation. Standard investigations fail to reveal any apparent cause in >50% of couples.

No study has demonstrated any benefit of any medication in women with Unexplained RM, in the presence or absence of an inherited thrombophilia.

Moreover, the benefit of aspirin and/or heparin has not been proved in women with Antiphospholipid (APL) antibody without other clinical manifestations of Antiphospholipid Syndrome.

Hydroxychloroquine (HQ) is a molecule whose properties (anti-thrombotic, vascular-protective, immunomodulatory, improved glucose tolerance, lipid-lowering, anti-infectious) could be useful against mechanisms of Unexplained RM.

There is no data concerning the benefit of HQ in RM in the presence or absence of antiphospholipid antibodies or any inherited thrombophilia.

Administration in (Systemic Lupus erythematosus (SLE) women and for Malaria prevention provides extensive safety data during pregnancy.

Oral administration makes possible treatment since the preconception period. For all of that and its low cost, hydroxychloroquine should be evaluated in RM whatever the woman thrombophilic status.

ReferenceCitation: Pasquier E, de Saint-Martin L, Marhic G, Chauleur C, Bohec C, Bretelle F, Lejeune-Saada V, Hannigsberg J, Plu-Bureau G, Cogulet V, Merviel P, Mottier D. Hydroxychloroquine for prevention of recurrent miscarriage: study protocol for a multicentre randomised placebo-controlled trial BBQ study. BMJ Open. 2019 Mar 20;9(3):e025649. doi: 10.1136/bmjopen-2018-025649.

apc_source: openAPC

family: Pasquier

full_name: Elisabeth Pasquier

given: Elisabeth

family: de Saint-Martin

full_name: Luc de Saint-Martin

given: Luc

family: Marhic

full_name: Gisèle Marhic

given: Gisèle

family: Chauleur

full_name: Celine Chauleur

given: Celine

family: Bohec

full_name: Caroline Bohec

given: Caroline

family: Bretelle

full_name: Florence Bretelle

given: Florence

family: Lejeune-Saada

full_name: Véronique Lejeune-Saada

given: Véronique

family: Hannigsberg

full_name: Jacob Hannigsberg

given: Jacob

family: Plu-Bureau

full_name: Geneviève Plu-Bureau

given: Geneviève

family: Cogulet

full_name: Virginie Cogulet

given: Virginie

family: Merviel

full_name: Philippe Merviel

given: Philippe

family: Mottier

full_name: Dominique Mottier

given: Dominique

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

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

location_facility:
CHU de Saint Etienne - Hôpital Nord
CHU de Nantes
CHRU de Lille
Hopital Saint Antoine
Hôpital Bichat
CH d'Auch
CHG François Mitterand
CHU Estaing
Nouvel Hôpital Civil
Hôpital Nord - Unité mère-enfant
CH de Mont de Marsan
CH de Bigorre
Centre hospitalier de Cornouaille
CHU Besançon
CHRU de Brest
Hopital Port Royal Cochin
Hôpital sud de Rennes
Centre Hospitalier Annecy Genevois