title: Pembrolizumab in Combination With Xelox Bevacizumab in Patients With Microsatellite Stable Mestatic Colorectal Cancer and a High Immune Infiltrate : a Proof of Concept Study

acronym: POCHI

summary:
About 85% of cases of non-metastatic colorectal cancer (CRC) are related to chromosomal instability and have a proficient DNA Mismatch-Repair system (pMMR); which are also called CRC with microsatellite stability (MSS). Other CRC, i.e. 15%, are "microsatellite unstable" (MSI) with deficient DNA Mismatch-Repair system (dMMR). These latter are characterised by generation of many neo-antigens, which result in a high anti-tumour immune response and a high peri- and/or intra-tumour lymphocyte infiltration (TIL). Investigators recently showed, with a prospectively validated immune score, that 14% of localised MSS/pMMR CRC are also highly infiltrated by CD3+ lymphocytes. This same immune score has made it possible to measure high lymphocyte infiltration in hepatic metastases, in particular, in patients treated with XELOX/FOLFOX.

Pembrolizumab, an anti-PD1 monoclonal antibody (programmed death-1) is an immune checkpoint inhibitor (ICI) of PD1/PD-L1 axis, recently approved in many cancers. Anti-PD1 antibodies have recently been reported as being very effective in patients with dMMR metastatic CRC (mCRC). In the study by Le DT et al. pMMR mCRC did not seem to benefit from anti-PD1 antibodies. However, it is possible that 20% of pMMR mCRC with a high CD3+ infiltrate in the tumour may be a subgroup of pMMR mCRC sensitive to ICI, as is the case for dMMR mCRC. Lastly, immunogenic cell death induced by chemotherapy, such as oxaliplatin, can increase the efficacy of ICI.

The prognostic value of lymphocyte infiltrate has been demonstrated in CRC by several teams. However, no validated test is used in routine clinical practice. Previously, investigators described an automated and reproducible method for analysis of TIL and investigators validated it for clinical use. Automated tests evaluating TIL are performed on virtual slides and have showed that, out of 1,220 tumours tested, 20% were highly infiltrated by CD3+ T cells. Patients presenting with a pMMR CRC with a high immune infiltrate had a better progression-free survival (HR=0.70; p=0.02). An immunoscore® described by Galon et al. has also a high prognostic value in CRC and is based on CD3+ and CD8+ T cells infiltration in the center and periphery of the tumour. Finally, approximately 14% of tumours with a high immune infiltrate have been found in patients with metastatic CRC.

Investigators formulated the hypothesis that patients with a pMMR CRC with a high immune infiltrate can be sensitive to ICI . Therefore, blocks of resected primary tumour will be collected and analysed prospectively. For each patient, slides containing tumour tissue and adjacent non-tumour tissue will be analysed using two techniques : immunoscore® and TuLIS score.It consist in Immunohistochemistry with CD3 and CD8 staining. Slides will be scanned and analysed by image analysis as previously described . Tumours will then be classified as having a "high" or "low" immune response according to type of lymphocyte infiltrate, which is independent of pre-analytic conditions. Only patients with a high immune response will be eligible for the POCHI trial. Other biomarkers will be analysed like other immune populations or mutational load. If investigators identify an immune score which seems clinically relevant to predict sensitivity to ICI in pMMR mCRC, this will make it possible to plan a randomised phase III trial comparing chemotherapy and anti-angiogenic antibody versus chemotherapy and anti-angiogenic antibody plus pembrolizumab in patients with a pMMR mCRC with a high immune score and/or a hypermutated genotype.

Investigators choose PFS at 10 months as primary endpoint in POCHI trial because it is a surrogate marker of OS. Actually median PFS in first-line setting with a doublet plus a biological agent is range from 8 to 11 months in unresectable mCRC, corresponding to a PFS of 50% at 10 months. The alternative clinical hypothesis to obtain 70% of patients alive and without progression at 10 months is ambitious and currently not achieved with current chemotherapies plus a biological agent. Up until now there is no data concerning survivals outcomes of patients with a MSS mCRC with high immune infiltration score.

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family: Herbst

full_name: Roy S. Herbst

given: Roy S.

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

family: Kowanetz

full_name: Marcin Kowanetz

given: Marcin

family: Fine

full_name: Gregg D. Fine

given: Gregg D.

family: Hamid

full_name: Omid Hamid

given: Omid

family: Gordon

full_name: Michael S. Gordon

given: Michael S.

family: Sosman

full_name: Jeffery A. Sosman

given: Jeffery A.

family: McDermott

full_name: David F. McDermott

given: David F.

family: Powderly

full_name: John D. Powderly

given: John D.

family: Gettinger

full_name: Scott N. Gettinger

given: Scott N.

family: Kohrt

full_name: Holbrook E. K. Kohrt

given: Holbrook E. K.

family: Horn

full_name: Leora Horn

given: Leora

family: Lawrence

full_name: Donald P. Lawrence

given: Donald P.

family: Rost

full_name: Sandra Rost

given: Sandra

family: Leabman

full_name: Maya Leabman

given: Maya

family: Xiao

full_name: Yuanyuan Xiao

given: Yuanyuan

family: Mokatrin

full_name: Ahmad Mokatrin

given: Ahmad

family: Koeppen

full_name: Hartmut Koeppen

given: Hartmut

family: Hegde

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given: Priti S.

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location_facility: Privé - Cac - Paul Strauss / Institut de Cancérologie de Strasbourg Europe

location_facility: Chu - Centre Hospitalier Universitaire Robert Debre

location_facility: Privé - Cac - Ico - Site René Gauducheau

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

location_facility: Privé - Cac - Centre Georges-Francois Leclerc

location_facility: CH - GROUPE HOSPITALIER DE La Rochelle RE AUNIS

location_facility: Privé - Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie

location_facility: Chu - Centre Hospitalier Universitaire de Saint Etienne - Hôpital Nord - Service Hge

location_facility: Ch - Centre Hospitalier de La Côte Basque

location_facility: Privé - Cac - Institut de Cancerologie de Lorraine

location_facility: Chu - Centre Hospitalier Universitaire Pontchaillou

location_facility: Chu - Hôpital Morvan - Institut de Cancérologie

location_facility: Privé - Polyclinique de Blois - 3Eme Etage


title: Sevoflurane for Sedation in Acute Respiratory Distress Syndrome: A Multicenter Prospective Randomized Trial

acronym: SESAR

summary:
This study evaluates whether a sedation with inhaled sevoflurane will decrease mortality and increase time off the ventilator at 28 days in patients with acute respiratory distress syndrome (ARDS).

Half of the patients will receive inhaled sedation with sevoflurane and the other half will receive intravenous sedation with propofol.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Timone Hospital - Assistance Publique-Hôpitaux

location_facility: Cavale Blanche Hospital - University Hospital

location_facility: Saint-Antoine University Hospital - Assistance Publique-Hôpitaux

location_facility: Hautepierre Hospital, University Hospitals

location_facility: Saint-Eloi Hospital - University Hospital

location_facility: Saint-Louis University Hospital - Assistance Publique-Hôpitaux

location_facility: Pitié-Salpêtrière Hospital, - Assistance Publique-Hôpitaux

location_facility: Lapeyronie Hospital - University Hospital

location_facility: Hotel Dieu Hospital - University Hospital

location_facility: Pasteur 2 Hospital - University Hospital

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Phase II, Multi-centre Study, to Evaluate the Efficacy and Safety of Osimertinib Treatment for Patients With EGFR-mutated Non-small Cell Lung Cancer (NSCLC) With Brain or Leptomeningeal Metastases

acronym: ORBITAL

summary:
Treatment of non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation is mainly based on tyrosine kinase inhibitors (TKIs) targeting EGFR. 1st or 2nd generation inhibitors have been shown to be superior to chemotherapy in terms of Progression-Free Survival (PFS) when used as 1st line treatment.

In case of progression at several metastatic sites, systemic treatment will be considered and will depend on the presence of the TKI resistance mutation, the T790M mutation. In the presence of the T790M mutation, osimertinib is superior to chemotherapy in terms of progression-free survival, while in the absence of the T790M mutation, platinum salt chemotherapy is recommended. In case of local progression, treatment of the site in progression by radiotherapy and/or surgery is considered. As these local treatments can cause long-term adverse effects, systemic treatments are increasingly being considered in this indication.

Brain and leptomeningeal metastases are the most frequent isolated site of progression in EGFR mutated patients treated with TKI. The high frequency of isolated cerebral and leptomeningeal progression is a consequence of the lower diffusion of 1st and 2nd generation TKIs in the central nervous system (CNS). Osimertinib is a 3rd generation TKI that has the particularity of overcoming the T790M mutation and having greater brain penetration than 1st or 2nd generation TKIs, which could make it an attractive therapeutic option in the event of brain progression or leptomeningeal progression. However, its efficacy in patients with cerebral or leptomeningeal metastases is still poorly understood.

ipd_sharing: Undecided

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

location_facility: Hospices Civils de Lyon - Hôpital Lyon syd

location_facility: Centre Hospitalier Intercommunal de Créteil

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

location_facility: Centre Hospitalier de Villefranche-sur-Saône

location_facility: Centre Hospitalier Régional - Hôpital de la Source

lead_sponsor_type: industriel


title: Study on the Dimethyl Fumarate (DMF, Tecfidera®) Persistence of Remitting-relapsing Multiple Sclerosis (RR-MS) Patients Included in the French Patient Support Program (PSP) OroSEP

acronym: TEC-ADHERE

summary:
The primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without OroSEP patient support program (PSP), respectively.

The secondary objectives are: to compare oral DMF persistence at one month and three months in RR-MS participants initiating DMF with and without OroSEP PSP, respectively; To compare oral DMF adherence at six months in RR-MS participants initiating DMF with and without OroSEP PSP; To compare at three months and six months the reason of oral DMF discontinuation, in the two groups; To describe the percentage of participants with treatment-related adverse events globally and by class of adverse events, in the two groups of participants; To assess the evolution of participants' anxiety globally and to compare it at inclusion and at six months in participants with and without OroSEP PSP, respectively; To describe participants' satisfaction regarding oral DMF initiation and follow-up globally at six months and to compare it in patients with and without OroSEP PSP, respectively;

For OroSEP PSP group: To assess participants' satisfaction regarding their participation in OroSEP PSP at six months; To assess neurologists' satisfaction regarding their participation in OroSEP PSP, after the last participant last visit of center.

study_type: Observational

time_perspective: Prospective

ipd_sharing: Yes

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_facility:
Research site
Research Site

intervention_type: Other


title: Assessment of Quitting Versus Using Aspirin Therapy In Patients Treated With Oral Anticoagulation for Atrial Fibrillation With Stabilized Coronary Artery Disease

acronym: AQUATIC

summary:
Long-term aspirin (ASA) is the standard recommended antithrombotic therapy in patients with stable coronary artery disease (CAD), especially following stenting (Class I, Level A).
Long-term oral anticoagulation (OAC) is the standard antithrombotic therapy in patients with atrial fibrillation (AF) associated with one or more risk factor for stroke (Class I, Level A).
During the first year following acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), several studies evaluating the combination of OAC treatment and antiplatelet therapy are either already published or ongoing.
At distance of the index ACS and/or PCI, patients with stable CAD and concomitant AF remain at particular high-risk of ischemic (3 to 4 times higher as compared to patients with stable CAD without AF) and bleeding events. Antithrombotic management of these patients is subsequently highly challenging in clinical practice. The European task force suggests that the use of a full-dose anticoagulant monotherapy without any antiplatelet therapy should be the default strategy in such patients with both, AF and stable CAD.
However, evidences are sparse and weak to support such a strategy (only observational studies with many biases) and no randomized trial has assessed this question. These patients, especially those at high-risk of recurrent ischemic events (post- ACS, diabetes, multivessel CAD…) may benefit from the combination of OAC and aspirin at long-term. Indeed the crude event rate of ischemic events is much higher than the crude event rate of bleeding in this specific population. Ischemic events are 2 to 3 times more frequent than bleeding in daily practice.
The benefit/risk ratio of these two different strategies (ASA in combination with OAC vs. OAC alone) in patients at high-risk of recurrent coronary and vascular events remains unknown. Dual therapy with full-dose anticoagulation and ASA may lead to higher risk of major bleeding, while stopping ASA in stabilized high-risk patients after PCI may lead to poorer outcome regarding ischemic events.
The coordinating investigators therefore designed a double blind placebo controlled trial in order to assess the optimal antithrombotic regimen that should be pursued long-life in this subset of patients.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: No

lead_sponsor: University Hospital, Brest

location_facility: CH Louis Pasteur - Chartres - Le Coudray

location_facility: Centre Hospitalier René Dubos - Cergy Pontoise

location_facility: Hôpital Haut Lévêque -CHU Bordeaux-Pessac


title: A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study

summary:
There are no prospective studies of pregnancies for the diseases studied here in (Heredity Hemorrhagic Telangiectasia, Marfan syndrome, primary lower limb lymphedema, superficial arteriovenous malformations, and cerebro-spinal arteriovenous malformations) although complications of these can present life-threatening health problems for the mother and her baby.

The purpose of this National prospective study is to obtain greater insight into obstetrical complications associated with rare maternal vascular genetic disorders in order to improve prevention and to reduce risk of death.

In this context, experts and patient associations consider that there is a need to make real progress in the formulation of recommendations based on scientific data.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Référence pour la maladie de Rendu-Osler - Service Génétique Clinique - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon

location_facility: Service de Neuroradiologie - AP-HP - Paris (Hôpital Lariboisière)

location_facility: Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers

location_facility: Service de Pneumologie CHU de Rennes - Hôpital Pontchaillou

location_facility: Service Médecine Interne - Hôpital Saint-Eloi, CHU de Montpellier

location_facility: Service de Lymphologie - Hôpital Cognacq-Jay - Paris

location_facility: Service de Neuroradiologie Interventionnelle - Hôpital Foch

location_facility: Service de Médecine interne et immunologie clinique + Service de Médecine Vasculaire - Hôpital Saint André, CHU de Bordeaux

location_facility: Service Médecine Interne - Médecine vasculaire - CHU de Rouen, Hôpital Charles Nicolle

location_facility: Service Radiologie-pneumologie interventionnelle - Hôpital Tenon AP-HP

location_facility: Service d'imagerie médicale - Neuroradiologie interventionnelle - Hôpital Neurologique P. Wertheimer - HCL

location_facility: Service Pneumologie + Service de Dermatologie _ Hôpital Bretonneau Centre Hospitalier Régional Universitaire de TOURS

location_facility: Service de Médecine vasculaire et HTA - Hôpital Albert Calmette, CHRU de Lille

location_facility: Unité de neuro-interventionnelle CHU Nice, Hôpital Pasteur 2

location_facility: Service de Cardiologie - Hôpital Bichat, AP-HP

location_facility: Service de Médecine Vasculaire et Thérapeutique, Explorations Fonctionnelles Vasculaires - CHU de Saint-Etienne - Hôpital Nord

location_facility: Clinique cardiologique et des maladies vasculaires CHU de Nantes, Hôpital G. R. LAENNEC

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterrand

location_facility: Service Médecine Interne Estaing CHU de Clermont-Ferrand - Hôpital d'Estaing

location_facility: Service de neuroradiologie diagnostique et interventionnelle - CHU de Nancy, Hôpital St-Julien

location_facility: Service de Médecine Vasculaire - Hôpital de la Côte de Nacre

location_facility: Service de Génétique Médicale, Hôpital de Hautepierre

location_facility: Service Médecine interne - CHRU de Lille - Hôpital Claude Huriez

location_facility: Service de Neuroradiologie Interventionnelle - Fondation Adolphe de Rothschild

location_facility: Unité de Génétique médicale, CHU de Rennes, Hôpital Sud

location_facility: Service de Cardiologie _ Hôpital des Enfants (Purpan)

location_facility: Service de Médecine Interne + Service Médecine Vasculaire _ Hôpital RANGUEIL

location_facility: Service d'Imagerie Pédiatrique et Fœtale et Consultation Pluridisciplinaire des Angiomes - Hôpital Femme-Mère-Enfant - HCL

location_facility: Service Pneumologie et Oncologie Thoracique - AP-HP Hôpital Ambroise Paré


title: Evaluation of a Marine OXYgen Carrier for Organ Preservation : a Multicenter Randomized Study Evaluating the Efficacy of HEMO2life® Versus Standard of Care in Renal Transplantation

acronym: OXYOP 2

summary:
Preventing ischemia/reperfusion injuries (IRIs) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRIs is delayed graft function (DGF).

The medical device HEMO2life®, an oxygen carrier developed by the Hemarina French Company, is a natural extracellular hemoglobin (Hb) isolated from the marine lugworm Arenicola marina. This biopolymer of high molecular weight (~3,600 kDa) has a large oxygen binding capacity, carrying up to 156 oxygen molecules when saturated (4 for human Hb). It releases oxygen according to a simple gradient and exhibits an intrinsic superoxide dismutase-like activity preventing both the occurrence of potentially harmful heme-protein-associated free radical species and the release of Hb degradation products.

Recently a safety study in 60 renal grafts using HEMO2life® as additive to organ preservation solution (Oxyop study, NCT02652520) was completed, that confirmed that the use of HEMO2life® is safe for patients and grafts.

In the Oxyop study, even if the protocol was not designed to show a benefit of the use of HEMO2life®, significantly less delayed graft function (DGF) and a shorter renal function recovery was observed.

The present research focuses on the efficacy of HEMO2life®, which is an oxygen carrier added in preservation solution in kidney transplantation.

primary_purpose: Other

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
Nantes
Rouen
APHP Saint-Louis
Nancy
CHRU de Brest
APHP Bicêtre
Nice
Montpellier
APHP Necker
Amiens
Toulouse
Poitiers
Strasbourg
Marseille
Lyon
Grenoble
Saint-Etienne
Bordeaux
Besançon
Limoges
APHP Henri Mondor
Lille
Association Hopital Foch
Dijon
Angers
Caen
Tours
Paris La Salpétrière
Reims
Rennes
Clermont-Ferrand
La Réunion

intervention_type: Procedure


title: Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms

acronym: MPN-BIOCLOT

summary: Thrombosis is the main cause of morbidity and mortality in patients with myeloproliferative neoplasms (MPN). However, the pathogenesis of thrombosis in MPN is still largely elusive. Neutrophils can release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". NETs are known to be procoagulant. Our main objective is to quantify NETs biomarkers expression in MPN patients and define if they could be used as prognostic factors in the outcome of thrombosis in these patients.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU Bordeaux, Hématologie Clinique et Thérapie Cellulaire

location_facility: Hôpital Européen Georges Pompidou - APHP

intervention_type: Biological


title: LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy

acronym: LONGBOARD

summary: Prospective cohort of patients treated with trifluridine/tipiracil, maximal sample size 250 patients. It is expected, that 89 patients will experience a grade 3-4 neutropenia and will be included in the phase II.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital Franco-Britannique
Hôpital Henri Mondor
Clinique de Flandre
CHU Poitiers
Polyclinique Sainte Côme
Hôpital Nord Franche Comté
CHU Amiens
Hôpital Haut Lévêque
Hôpital Saint Antoine
CHRU Jean Minjoz
Centre hospitalier de Chauny
Hôpital Européen
Hôpital Privé Jean Mermoz
CHU Robert Debré
Groupe Hospitalier Pitié Sapêtrière
Hôpital Cochin
CHD Vendée
centre Pierre Curie
Hôpital Layne
Institut de cancérologie de l'Ouest
Centre Georges François Leclerc
Polyclinique Bordeaux Nord


title: Comparison of Corticosteroids Versus Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the Intensive Care Unit: a Multicentre Randomized Controlled Trial

acronym: Corticop

summary: The main objective of this study is to determine if the systemic (intravenous) administration of corticosteroids, as compared to placebo, increases the number of ventilator-free days (VFD) and alive at day 28 in COPD patients admitted to an ICU, a step-up unit or a respiratory care unit for an ACRF requiring ventilatory support, either invasive or non-invasive.

lead_sponsor: Versailles Hospital

location_facility: André Mignot Hospital, Intensive care unit


title: Observational Retrospective Cohort Study in Patients With Relapsed Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated With Olaparib Following Response to Platinium-based Chemotherapy

acronym: RETROLA

summary: This is a national, multi center, retrospective observational cohort study that will be carried out by reviewing the medical records of patients with relapsed epithelial ovarian, fallopian tube, or peritoneal cancer treated with olaparib following response to platinum-based chemotherapy.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Clinique Mutualiste de l'Estuaire, Cité Sanitaire

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire

status_simplified: Completed


type: EudraCT Number

title: Phase II, Open Label Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC) for Advanced Breast Cancer Patients, With Biomarkers Analysis to Characterize Response/Resistance to Therapy

acronym: DAISY

summary: Multicenter, open-label phase II trial assessing the efficacy of DS-8201a monotherapy in patients with metastatic breast cancer.

status: Active, not recruiting

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Universitaire Dupuytren

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

location_facility: Institut de Cancérologie Strasbourg Europe (ICANS)

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

location_facility: Institut Régional du Cancer Montpellier (ICM)


title: Pilot and Phase 2 Study of the Efficacy of a Treatment Protocol With Dexamethasone Implant Loading Dose in Patients With Diabetic Macular Edema

acronym: LOADEX

summary:
Nowadays, steroids and anti-VEGF are the first line treatment for diabetic macular edema. Ozurdex is the most frequently used steroid and has label for both first and second line treatment. Ozurdex treatment paradigm for patients with diabetic macular edema is to inject patient only in case of huge recurrence. The risk of this scheme is a progressive loss of vision due to photoreceptors loss. A more pro-active regimen, as it already exists for anti-VEGF treatment, would allow a better patient management. A new treatment paradigm consisting in a loading dose of 2 injections within 3 months, followed by a PRN (Pro Re Nata) regimen with strict retreatment criteria and minimal time limit of 3 months between two injections should result in a better visual acuity gain and a limited augmentation of the number of injections (which will remain lower than the number observed for anti-VEGF treatment).

The investigators have therefore chosen a pilot study to investigate the impact on efficacy and on the number of intravitreal injections (IVI) of such a scheme.

location_facility: Centre Hospitalier National d'Ophtalmologie des XV XX

location_facility: CHU Toulouse - Hôpital Pierre Paul Riquet

location_facility: Centre Monticelli Paradis d'ophtalmologie

location_facility: Hôpital d'instruction des armées Desgenettes

location_facility: Hospices Civils de Lyon - Hopital de la Croix Rousse


type: Registry Identifier

title: Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients - a GETUG-AFU Phase III Randomized Controlled Trial

acronym: PRESTO

summary:
INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study.

PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.

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

intervention_type: Radiation


title: A Phase II Non-randomized, Single Group Assignment, Open-label, Multicenter Study of Efficacy and Safety of lORlatinib (PF-06463922) Monotherapy After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung cancEr

acronym: ORAKLE

summary: Crizotinib is a first-generation ALK tyrosine kinase inhibitor (ITK-ALK). It is the standard first-line treatment for patients with advanced NSCLC with ALK gene rearrangement. Alectinib, ceritinib and brigatinib are second-generation ITK-ALK. They have been shown to be effective in the first line of treatment in randomized trials. Alectinib has shown superiority to crizotinib as the first line of treatment in three randomized therapeutic trials, positioning this ITK-ALK as the treatment of choice in first-line treatment. Despite the effectiveness of these new treatments, all patients will virtually experience a relapse. There is no data on second-generation TKI-ALK resistance mechanisms when given as first-line treatment and the best therapeutic strategy for progression is undefined.

location_facility:
Colmar - CH
Bayonne - CH
Bordeaux - CHU Hôpital Haut-Lévèque
Vandoeuvre-lès-Nancy - CRLCC
Annecy - CH
Créteil - CHI
Paris - Curie
Besançon - CHU
Mulhouse - GHRMSA
Paris - APHP - Hopital Tenon
Nantes - CRLCC
Caen - CHU Côte de Nacre
Toulouse - CHU
Montpellier - Clinique
Angers - CHU
Lyon - URCOT
Suresnes - Hopital Foch
Paris - Hôpital Cochin
Marseille - Institut Paoli Calmette
Grenoble - CHU
Lille - Hôpital Calmette
Lyon - CRLCC
Orléans - CHR
Strasbourg - Nouvel Hôpital Civil
Le Mans - CHG
Paris - APHP Bichat
Saint Quentin - CH
Marseille - AP-HM Hôpital Nord
Boulogne - Ambroise Paré
Montpellier - CHU
Toulon - CHI
Dijon - CRLCC


title: Memento-Plus : Long-term Follow-up of Cognitive and Functional Evolutions of Persons With Isolated Cognitive Complaints or Mild Cognitive Deficits

acronym: Memento-Plus

summary:
Dementia is a clinical syndrome that is the result of distinct underlying pathologies including Alzheimer's disease (AD). Despite more than two decades of research on prevention and treatment of dementia and aging-related cognitive decline, highly effective preventive and therapeutic strategies remain elusive.

Many features of dementia render it especially challenging. Indeed development of disease occurs insidiously over the course of years or decade. In addition, the causes of dementia and determinants of its severity are likely multi-factorial.

To overcome these challenges and better understand the causes and course of AD and related disorders, long term follow-up studies of persons at high risk of dementia are required including multidimensional and harmonized assessment of risk factors, phenotypes (cognition, neuropsychiatric symptoms, physical health, self rated health) and endophenotypes (blood markers, genetic markers, neuroimaging markers).

This project proposes an extension of the follow-up of Memento participants over 5 to 10 years with of focus on cognitive outcomes and comorbidities.

location_facility: APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal


title: Double-blind, Randomised, Parallel-group, Three-arm, Dose Range, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy, Tolerability and Safety of a Combination of Cypropheptadine and Prazosin on Alcohol Consumption in Patients With Severe Alcohol Use Disorder

acronym: COCKTAIL

summary:
Double-blind randomised, parallel-group, three-arm, multicentre, placebo-controlled study The primary objective is to demonstrate the superiority of the combination of Periactine® (cyproheptadine 8 mg/day or 12 mg/day) and Alpress® (prazosin 5 mg/day or 10 mg/day) over placebo on the reduction of the total alcohol consumption (TAC), in alcohol-dependent patients.

180 patients will be randomised into the two treatment groups (N=60 in the low-dose group and N=60 in the high-dose group) and the placebo group (N=60).

lead_sponsor: Kinnov Therapeutics

location_facility: Association Hospitalière de Bourgogne Franche-Comté

location_facility: Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie

location_facility: Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques

location_facility: Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie

location_facility: CHU Provences-Alpes Côte d'Azur Hôpital Publique

location_facility: Centre Hospitalier universitaire de Nice - Hôpital Archet II

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu

location_facility: Centre Hospitalier Universitaire de Dijon - Service d'addictologie

location_facility: Centre hospitalier Esquirol - Pôle d'addictologie en Limousin

location_facility: Centre Hospitalier de Pau - Unité d'addictologie

location_facility: Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse

location_facility: Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier

location_facility: Centre Hospitalier de la Côte Basque - Service d'addictologie

location_facility: Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia

location_facility: Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif


title: A Phase II Single-arm Trial Evaluating Safety and Efficacy of Durvalumab in ECOG Performance Status 2-3, Treatment-naive, Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) and High PD-L1 Tumor Expression

acronym: SAVIMMUNE

summary:
Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently demonstrated clinical efficacy in several cancer types, and have changed the therapeutic landscape in metastatic melanoma or non-small cell lung cancer (NSCLC).

The monoclonal anti-PD-1 antibody nivolumab has been registered by both FDA (Food and Drug Administration) and EMA (European Medicine Agency), for metastatic NSCLC patients, after failure of a prior platinum-based chemotherapy.

The approval was based on the results of phase III clinical trials in metastatic NSCLC. But all the trials only enrolled patients with good general condition, PS (Performance Status) 0 or 1. However, the prevalence of poor PS patients at time of diagnosis is high in lung cancer patients.

For patients with metastatic NSCLC and PS 3, there is no standard treatment except best supportive care, since all trials that accrued unselected PS 3 patients fail to prove any survival advantage, and most PS >3 patients die within 2 to 4 months from diagnosis. Indeed, these patients are currently excluded from clinical trials. Specific dedicated clinical trials and treatment guidelines for this patient population are urgently needed, taking into account for the high prevalence of such patients.

location_facility: Nancy - Institut de Cancérologie de Lorraine


title: Randomised Phase 2 Trial Testing the Addition of Upfront Stereotactic Radiosurgery to Binimetinib Encorafenib Pembrolizumab Compared to Binimetinib Encorafenib Pembrolizumab Alone in BRAFV600 Mutation-positive Melanoma With Brain Metastasis

acronym: BEPCOME-MB

summary: This study evaluates the addition of stereotactic radiosurgery (SRS) to the combination of binimetinib + encorafenib + pembrolizumab in the treatment of BRAFⱽ⁶⁰⁰ mutation-positive melanoma with brain metastases (MBM).

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_facility: CLCC - Institut de Cancerologie de l'Ouest - Nantes

location_facility: CLCC - Institut de Cancerologie de Montpellier

location_facility: CLCC - IUCT-0 / Institut Claudius Regaud

location_facility: APHP - L'hôpital de la Pitié-Salpêtrière


title: A Multicentre, Open-label Phase II Trial Evaluating the Safety and Efficacy of Ponatinib Induction Followed by Imatinib Maintenance in Adult Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) ≤ 65 Years

acronym: TIPI

summary:
The investigators hypothesize that, in newly diagnosed de novo chronic phase CML patients, an induction treatment with ponatinib for 6 months should increase the rate of patients reaching a stable MR4.5 allowing cessation of imatinib treatment.

The investigators proposal is to conduct a multicenter, Phase II trial to evaluate the safety, clinical and biological activity of an induction treatment with ponatinib for 6 months, followed by a consolidation treatment with imatinib in newly diagnosed de novo chronic phase CML patients.

lead_sponsor: Centre Leon Berard

location_facility: Institut de cancérologie Strasbourg Europe

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: CHU Nîmes Caremeau - Institut de Cancérologie du Gard

location_facility: Institut D'Hematologie de Basse Normandie


title: Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery: Randomized Controlled Open-label Trial

acronym: SMART ANGEL 2

summary: The investigators hypothesize that by monitoring and analyzing physiological parameters (heart rate, blood pressure, saturation) and well-being (pain, nausea, vomiting, comfort) the SMART ANGEL ™ device improves the quality of care after major or intermediate outpatient surgery. This active surveillance will result in a decrease in the rate of unplanned recourse (hospitalization, consultation, telephone call).

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre hospitalier universitaire Amiens-Picardie


title: A Multicentre Phase II, Open-label, Non-randomized Study Evaluating Platinum-Pemetrexed-Atezolizumab (+/- Bevacizumab) for Patients With Stage IIIB/IV Non-squamous Non-small Cell Lung Cancer With EGFR Mutations, ALK Rearrangement or ROS1 Fusion Progressing After Targeted Therapies

summary: The objective of this study is to assess the efficacy of the combination of Platinum (carboplatin or cisplatin), Pemetrexed, Atezolizumab+/- Bevacizumab if eligible, in stage IIIB/IV non-squamous non-small cell lung cancer patients with progression-enhancing mutations following targeted therapies.

design_allocation: Non-Randomized

lead_sponsor: Centre Francois Baclesse

location_facility: Hôpital Haut Lévêque,Centre François Magendie


type: Other Identifier

title: Cohort Study to Evaluate the Clinical Features of Patients With Epithelial Ovarian Cancer Depending on Tumoral Mutation of BRCA or Beyond BRCA Genomic Molecular Abnormalities

acronym: GREAT

summary: This is a prospective observational French multicenter cohort in patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014). The objective is to constitute a clinico-biological database that allows to correlate clinical and progressive features of ovarian cancer patients based on tumor genomics and molecular detected abnormalities.

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Centre Hospitalier Général d'Aix-en-Provence

location_facility: Institut de Cancérologie Lucien Leuwirth

location_facility: Hôpitaux Drôme Nord - Centre Hospitalier Romans

location_facility: Centre Médicale Sainte Feyre Alfred Leune

location_facility: Institut de Cancérologie du Gard - ONCOGARD

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: Centre de Cancérologe du Grand Montpellier

location_facility: Centre Hospitalier Intercommunal de Fréjus Saint Raphael

location_facility: Clinique du Mousseau (CMCO) - Ramsay Santé

location_facility: CHRU de Montpellier - Hôpital Saint-Eloi

location_facility: Hôpital d'Instruction des Armées Saint-Anne

location_facility: Polyclinique de Limoges - Clinique Chenieux


title: Evaluation of Risk-Adapted and MRD-Driven Strategy for Untreated Fit Patients With Intermediate Risk Chronic Lymphocytic Leukemia: a Randomized Phase II Trial Comparing FCR and a Chemo-free Combination of Venetoclax and Ibrutinib

acronym: ERADIC

summary:
The aim of this study is to test the potential benefit of an innovative combination of targeted therapy over the standard the immunochemotherapy (FCR). The interest in this study resides in an MRD driven discontinuation of the novel agents, and a fixed maximum duration of these agents. This design allows a true comparison of the efficacy of IV with the immuno-chemotherapy at 2 years of treatment and later.

Finally, other trials propose to include to all risk categories of patients, and we are developing here a stratification preventing the dilution of the results. The intermediate risk patients are the ones for which alternative to chemotherapy is critical, as chemotherapy is likely to alter the clonal evolution of their disease, whereas the low risk patients are already doing well with standard treatment and are likely to benefit from other therapies as well. The high risk patients, id est patients with 17p deletion and or TP 53 mutational status responded very well to new drugs as BTK inhibitors or BLC2 inhibitors.

ipd_sharing_description: At the end of the study, the participant data (DPI) collected in this study may be made available to other researchers who request it from the sponsor and if the rationale is the improvement of knowledge in the CLL. The provision will be evaluated by the sponsor.

lead_sponsor: French Innovative Leukemia Organisation

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Hôpital Avicenne - Centre de Recherche Clinique

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire


title: Tailored Multicomponent Program for Discomfort Reduction in Critically il Patients May Decrease Post-traumatic Stress Disorder in General ICU Survivors at One Year

acronym: PTSD-REA

summary: Reducing discomfort in the intensive care unit (ICU) should be beneficial to longterm outcomes. This study assesses whether a tailored multicomponent program for discomfort reduction may be effective in reducing post-traumatic stress disorder (PTSD) symptoms at 1-year in general ICU survivors.

ReferenceType: result

ReferenceCitation: Jones C. Surviving the intensive care: residual physical, cognitive, and emotional dysfunction. Thorac Surg Clin. 2012 Nov;22(4):509-16. doi: 10.1016/j.thorsurg.2012.07.003. Epub 2012 Aug 25. Review.

family: Jones

full_name: Christina Jones

given: Christina

sequence: first

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Thoracic Surgery Clinics

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Surviving the Intensive Care

ReferenceCitation: Jones C, Skirrow P, Griffiths RD, Humphris GH, Ingleby S, Eddleston J, Waldmann C, Gager M. Rehabilitation after critical illness: a randomized, controlled trial. Crit Care Med. 2003 Oct;31(10):2456-61.

ReferenceCitation: Pacella ML, Hruska B, Delahanty DL. The physical health consequences of PTSD and PTSD symptoms: a meta-analytic review. J Anxiety Disord. 2013 Jan;27(1):33-46. doi: 10.1016/j.janxdis.2012.08.004. Epub 2012 Sep 13. Review.

family: Pacella

full_name: Maria L. Pacella

given: Maria L.

family: Hruska

full_name: Bryce Hruska

given: Bryce

sequence: additional

family: Delahanty

full_name: Douglas L. Delahanty

given: Douglas L.

journal_name: Journal of Anxiety Disorders

title: The physical health consequences of PTSD and PTSD symptoms: A meta-analytic review

ReferenceCitation: Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

family: Pandharipande

full_name: P.P. Pandharipande

family: Girard

full_name: T.D. Girard

family: Jackson

full_name: J.C. Jackson

family: Morandi

full_name: A. Morandi

given: A.

family: Thompson

full_name: J.L. Thompson

family: Pun

full_name: B.T. Pun

family: Brummel

full_name: N.E. Brummel

family: Hughes

full_name: C.G. Hughes

family: Vasilevskis

full_name: E.E. Vasilevskis

family: Shintani

full_name: A.K. Shintani

family: Moons

full_name: K.G. Moons

family: Geevarghese

full_name: S.K. Geevarghese

family: Canonico

full_name: A. Canonico

family: Hopkins

full_name: R.O. Hopkins

family: Bernard

full_name: G.R. Bernard

family: Dittus

full_name: R.S. Dittus

family: Ely

full_name: E.W. Ely

title: Long-Term Cognitive Impairment after Critical Illness

ReferenceCitation: Davydow DS, Hough CL, Zatzick D, Katon WJ. Psychiatric symptoms and acute care service utilization over the course of the year following medical-surgical ICU admission: a longitudinal investigation*. Crit Care Med. 2014 Dec;42(12):2473-81. doi: 10.1097/CCM.0000000000000527.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Psychiatric Symptoms and Acute Care Service Utilization Over the Course of the Year Following Medical-Surgical ICU Admission

ReferenceCitation: Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med. 2006 Aug;32(8):1115-24. Epub 2006 Jun 17.

ReferenceCitation: Granja C, Lopes A, Moreira S, Dias C, Costa-Pereira A, Carneiro A; JMIP Study Group. Patients' recollections of experiences in the intensive care unit may affect their quality of life. Crit Care. 2005 Apr;9(2):R96-109. Epub 2005 Jan 31.

ReferenceCitation: McKinley S, Aitken LM, Alison JA, King M, Leslie G, Burmeister E, Elliott D. Sleep and other factors associated with mental health and psychological distress after intensive care for critical illness. Intensive Care Med. 2012 Apr;38(4):627-33. doi: 10.1007/s00134-012-2477-4. Epub 2012 Feb 9.

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

ReferenceCitation: Schelling G, Richter M, Roozendaal B, Rothenhäusler HB, Krauseneck T, Stoll C, Nollert G, Schmidt M, Kapfhammer HP. Exposure to high stress in the intensive care unit may have negative effects on health-related quality-of-life outcomes after cardiac surgery. Crit Care Med. 2003 Jul;31(7):1971-80.

ReferenceCitation: Bienvenu OJ, Gellar J, Althouse BM, Colantuoni E, Sricharoenchai T, Mendez-Tellez PA, Shanholtz C, Dennison CR, Pronovost PJ, Needham DM. Post-traumatic stress disorder symptoms after acute lung injury: a 2-year prospective longitudinal study. Psychol Med. 2013 Dec;43(12):2657-71. doi: 10.1017/S0033291713000214. Epub 2013 Feb 26.

ReferenceCitation: Davydow DS, Gifford JM, Desai SV, Needham DM, Bienvenu OJ. Posttraumatic stress disorder in general intensive care unit survivors: a systematic review. Gen Hosp Psychiatry. 2008 Sep-Oct;30(5):421-34. doi: 10.1016/j.genhosppsych.2008.05.006. Epub 2008 Jul 30. Review.

ReferenceCitation: Jones C, Griffiths RD, Humphris G, Skirrow PM. Memory, delusions, and the development of acute posttraumatic stress disorder-related symptoms after intensive care. Crit Care Med. 2001 Mar;29(3):573-80.

ReferenceCitation: Schelling G, Stoll C, Haller M, Briegel J, Manert W, Hummel T, Lenhart A, Heyduck M, Polasek J, Meier M, Preuss U, Bullinger M, Schüffel W, Peter K. Health-related quality of life and posttraumatic stress disorder in survivors of the acute respiratory distress syndrome. Crit Care Med. 1998 Apr;26(4):651-9.

ReferenceCitation: Jackson JC, Hart RP, Gordon SM, Hopkins RO, Girard TD, Ely EW. Post-traumatic stress disorder and post-traumatic stress symptoms following critical illness in medical intensive care unit patients: assessing the magnitude of the problem. Crit Care. 2007;11(1):R27. Review.

ReferenceCitation: Parker AM, Sricharoenchai T, Raparla S, Schneck KW, Bienvenu OJ, Needham DM. Posttraumatic stress disorder in critical illness survivors: a metaanalysis. Crit Care Med. 2015 May;43(5):1121-9. doi: 10.1097/CCM.0000000000000882. Review.

title: Posttraumatic Stress Disorder in Critical Illness Survivors

ReferenceCitation: Patel MB, Jackson JC, Morandi A, Girard TD, Hughes CG, Thompson JL, Kiehl AL, Elstad MR, Wasserstein ML, Goodman RB, Beckham JC, Chandrasekhar R, Dittus RS, Ely EW, Pandharipande PP. Incidence and Risk Factors for Intensive Care Unit-related Post-traumatic Stress Disorder in Veterans and Civilians. Am J Respir Crit Care Med. 2016 Jun 15;193(12):1373-81. doi: 10.1164/rccm.201506-1158OC.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Incidence and Risk Factors for Intensive Care Unit–related Post-traumatic Stress Disorder in Veterans and Civilians

ReferenceCitation: Garrouste-Orgeas M, Coquet I, Périer A, Timsit JF, Pochard F, Lancrin F, Philippart F, Vesin A, Bruel C, Blel Y, Angeli S, Cousin N, Carlet J, Misset B. Impact of an intensive care unit diary on psychological distress in patients and relatives*. Crit Care Med. 2012 Jul;40(7):2033-40. doi: 10.1097/CCM.0b013e31824e1b43.

ReferenceCitation: Cuthbertson BH, Rattray J, Campbell MK, Gager M, Roughton S, Smith A, Hull A, Breeman S, Norrie J, Jenkinson D, Hernández R, Johnston M, Wilson E, Waldmann C; PRaCTICaL study group. The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ. 2009 Oct 16;339:b3723. doi: 10.1136/bmj.b3723. Erratum in: BMJ. 2009;339. doi: 10.1136/bmj.b4445.

repository_institution: The University of Glasgow - Enlighten: Publications

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ReferenceCitation: Nelson JE, Meier DE, Oei EJ, Nierman DM, Senzel RS, Manfredi PL, Davis SM, Morrison RS. Self-reported symptom experience of critically ill cancer patients receiving intensive care. Crit Care Med. 2001 Feb;29(2):277-82.

ReferenceCitation: Novaes MA, Knobel E, Bork AM, Pavão OF, Nogueira-Martins LA, Ferraz MB. Stressors in ICU: perception of the patient, relatives and health care team. Intensive Care Med. 1999 Dec;25(12):1421-6.

ReferenceCitation: Rotondi AJ, Chelluri L, Sirio C, Mendelsohn A, Schulz R, Belle S, Im K, Donahoe M, Pinsky MR. Patients' recollections of stressful experiences while receiving prolonged mechanical ventilation in an intensive care unit. Crit Care Med. 2002 Apr;30(4):746-52.

ReferenceCitation: Simini B. Patients' perceptions of intensive care. Lancet. 1999 Aug 14;354(9178):571-2.

ReferenceCitation: Soehren P. Stressors perceived by cardiac surgical patients in the intensive care unit. Am J Crit Care. 1995 Jan;4(1):71-6. Review.

ReferenceCitation: Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Mallédant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med. 2010 Oct;36(10):1751-8. doi: 10.1007/s00134-010-1902-9. Epub 2010 May 26.

ReferenceCitation: Kalfon P, Baumstarck K, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Boucekine M, Fromentin M, Nyunga M, Sossou A, Venot M, Robert R, Follin A, Audibert J, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P; IPREA Study group. A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial. Intensive Care Med. 2017 Dec;43(12):1829-1840. doi: 10.1007/s00134-017-4991-x. Epub 2017 Nov 27.

ReferenceCitation: Kalfon P, Alessandrini M, Boucekine M, Renoult S, Geantot MA, Deparis-Dusautois S, Berric A, Collange O, Floccard B, Mimoz O, Julien A, Robert R, Audibert J, Renault A, Follin A, Thevenin D, Revel N, Venot M, Patrigeon RG, Signouret T, Fromentin M, Sharshar T, Vigne C, Pottecher J, Levrat Q, Sossou A, Garrouste-Orgeas M, Quenot JP, Boulle C, Azoulay E, Baumstarck K, Auquier P; IPREA-AQVAR Study Group. Tailored multicomponent program for discomfort reduction in critically ill patients may decrease post-traumatic stress disorder in general ICU survivors at 1 year. Intensive Care Med. 2019 Feb;45(2):223-235. doi: 10.1007/s00134-018-05511-y. Epub 2019 Jan 30.

ReferenceCitation: Creamer M, Bell R, Failla S. Psychometric properties of the Impact of Event Scale - Revised. Behav Res Ther. 2003 Dec;41(12):1489-96.

ReferenceCitation: Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

name: VA Portland Health Care System; Portland Oregon USA

name: Department of Psychology, Auburn University; Auburn Alabama USA

name: South Texas Veterans Health Care System; San Antonio Texas USA

ReferenceCitation: Birmes P, Brunet A, Benoit M, Defer S, Hatton L, Sztulman H, Schmitt L. Validation of the Peritraumatic Dissociative Experiences Questionnaire self-report version in two samples of French-speaking individuals exposed to trauma. Eur Psychiatry. 2005 Mar;20(2):145-51.

ReferenceCitation: Jehel L, Brunet A, Paterniti S, Guelfi JD. [Validation of the Peritraumatic Distress Inventory's French translation]. Can J Psychiatry. 2005 Jan;50(1):67-71. French.

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ReferenceCitation: Kubany ES, Haynes SN, Leisen MB, Owens JA, Kaplan AS, Watson SB, Burns K. Development and preliminary validation of a brief broad-spectrum measure of trauma exposure: the Traumatic Life Events Questionnaire. Psychol Assess. 2000 Jun;12(2):210-24.

ReferenceCitation: Bernstein DP, Fink L, Handelsman L, Foote J, Lovejoy M, Wenzel K, Sapareto E, Ruggiero J. Initial reliability and validity of a new retrospective measure of child abuse and neglect. Am J Psychiatry. 1994 Aug;151(8):1132-6.

ReferenceCitation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.

ReferenceCitation: Baumann C, Erpelding ML, Régat S, Collin JF, Briançon S. The WHOQOL-BREF questionnaire: French adult population norms for the physical health, psychological health and social relationship dimensions. Rev Epidemiol Sante Publique. 2010 Feb;58(1):33-9. doi: 10.1016/j.respe.2009.10.009. Epub 2010 Jan 21.

journal_name: Revue d'Épidémiologie et de Santé Publique

location_facility: Hôpital de Hautepierre_CHU de Strasbourg

location_facility: Husson Mourier_GH La Pitié-Salpêtrière-Charles Foix_APHP

location_facility: Gaston Cordier_GH La Pitié-Salpêtrière-Charles Foix_APHP

location_facility: GH La Pitié-Salpêtrière-Charles Foix_APHP


title: Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury

acronym: TRUST

summary: The investigators hypothesize that patients with mild TBI and normal TCD can be safely discharged home immediately after the ED. The targeted population is the category of patients eligible for early discharge: 1) patients with mild lesions on the initial CT scan and a GCS 15 after CT scan completion and, 2) patients with no lesion on the initial cerebral CT scan with at least one of the following risk factors: GCS 14 after CT scan completion, persisting post-traumatic nausea/vomiting/headaches, concomitant alcoholic intoxication or patients treated with aspirin. The study will not include mild TBI patients who are not eligible for early discharge: patients with no possibility of home supervision, those with a GCS lower than 14 after the CT scan or those treated with anticoagulant/antiplatelet drugs other than aspirin. The investigators expect the TCD-based strategy to be non-inferior compared to the standard strategy according to French recommendations in terms of the 3-months neurological outcome. From a public health standpoint, the use of TCD as a triage tool may change current guidelines regarding mild TBI management.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, Bragge P, Brazinova A, Büki A, Chesnut RM, Citerio G, Coburn M, Cooper DJ, Crowder AT, Czeiter E, Czosnyka M, Diaz-Arrastia R, Dreier JP, Duhaime AC, Ercole A, van Essen TA, Feigin VL, Gao G, Giacino J, Gonzalez-Lara LE, Gruen RL, Gupta D, Hartings JA, Hill S, Jiang JY, Ketharanathan N, Kompanje EJO, Lanyon L, Laureys S, Lecky F, Levin H, Lingsma HF, Maegele M, Majdan M, Manley G, Marsteller J, Mascia L, McFadyen C, Mondello S, Newcombe V, Palotie A, Parizel PM, Peul W, Piercy J, Polinder S, Puybasset L, Rasmussen TE, Rossaint R, Smielewski P, Söderberg J, Stanworth SJ, Stein MB, von Steinbüchel N, Stewart W, Steyerberg EW, Stocchetti N, Synnot A, Te Ao B, Tenovuo O, Theadom A, Tibboel D, Videtta W, Wang KKW, Williams WH, Wilson L, Yaffe K; InTBIR Participants and Investigators. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. Lancet Neurol. 2017 Dec;16(12):987-1048. doi: 10.1016/S1474-4422(17)30371-X. Epub 2017 Nov 6. Review.

ReferenceCitation: Tagliaferri F, Compagnone C, Korsic M, Servadei F, Kraus J. A systematic review of brain injury epidemiology in Europe. Acta Neurochir (Wien). 2006 Mar;148(3):255-68; discussion 268. Review.

ReferenceCitation: Davis DP, Kene M, Vilke GM, Sise MJ, Kennedy F, Eastman AB, Velky T, Hoyt DB. Head-injured patients who "talk and die": the San Diego perspective. J Trauma. 2007 Feb;62(2):277-81.

ReferenceCitation: af Geijerstam JL, Britton M. Mild head injury: reliability of early computed tomographic findings in triage for admission. Emerg Med J. 2005 Feb;22(2):103-7. Review.

lead_sponsor: University Hospital, Grenoble

location_country: Monaco France

location_facility:
Chu Reunion
CHRU Lille
CHU Toulouse
AP-HM Timone
CHU Grenoble Alpes
AP-HP Lariboisière
HCL - Lyon Sud
HCL - Edouard Herriot
CHU Nîmes
AP-HP Pitié Salpetrière
CHU Poitiers
CH Melun
CHU Clermont-Ferrand
CHU Réunion
CH Monaco
CHRU Montpellier
CHU Nantes
AP-HP - Avicenne
CH Bourg-en-bresse


title: Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery: IMPROVE-2 Multicenter Prospective Randomized Trial

summary: The aim of this study is to compare the effects of a strategy aimed at increasing alveolar recruitment (high PEEP levels adjusted according to driving pressure and recruitment maneuvers) with that of a strategy aimed at minimizing alveolar distension (low PEEP level without recruitment maneuver) on postoperative respiratory failure and mortality in patients receiving low VT ventilation during emergency abdominal surgery.

location_facility:
Assistance Publique-Hôpitaux de Paris
Institut Paoli Calmette
Hospital
University hospital


title: IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study.

summary:
Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available.

Therefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA.

As secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.

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

lead_sponsor: Pfizer

location_facility: Centre Hospitalier Montceau Les Mines-Hopital Jean Bouveri

location_facility: Centre Hospitalier Universitaire Saint Etienne Hopital Nord

location_facility: Centre Hospitalier Orleans-Hopital La Source

location_facility: Centre Hospitalier des Deux Vallees Juvisy

location_facility: Clinique de La Sauvegarde / Cabinet Le Trait D Union

location_facility: Centre Hospitalier Annecy Genevois Site Annecy

location_facility: Centre Hospitalier Universitaire de Lille - Hopital B Roger Salengro

location_facility: Centre Hospitalier de Bigorre Site La Gespe

location_facility: Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie

location_facility: Centre Hospitalier Universitaire La Reunion Site Felix Guyon

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Centre Hospitalier Departemental Vendee Les Oudairies


title: Management of Paroxystic Atrial Fibrillation in French Intensive Care Units

acronym: PAF-ICU

summary: The primary purpose of the study is to evaluate treatment of new onset atrial fibrillation in french ICU.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Institut Régional du Cancer de Montpellier


title: Phase III Randomized Trial of Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Monthly Carboplatin With Weekly Paclitaxel Chemotherapy

acronym: ELDERLY

summary: Non Small Cell Lung Cancer (NSCLC) remains the leading cause of death by cancer in the world. Because of the increase in lung cancer incidence with age and the increase of life expectancy, about half of the patients are patients aged 70 or older. Several clinical trials have shown the interest of adding immunotherapy to standard 1st line chemotherapy in NSCLC. Although in these studies there was not necessarily a higher age limit, in fact the proportion of included patients aged 75 or older remains low (between 7 and 10%). It is therefore necessary to conduct a trial dedicated to these patients in order to determine whether immunotherapy is as effective and tolerated as in the general population.

ReferenceCitation: Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavolé A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducoloné A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancérologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Oster

full_name: Jean-Philippe Oster

given: Jean-Philippe

family: Westeel

full_name: Virginie Westeel

given: Virginie

family: Pichon

full_name: Eric Pichon

given: Eric

family: Lavolé

full_name: Armelle Lavolé

given: Armelle

family: Dauba

full_name: Jérôme Dauba

given: Jérôme

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

family: Bigay-Game

full_name: Laurence Bigay-Game

given: Laurence

family: Dansin

full_name: Eric Dansin

family: Poudenx

full_name: Michel Poudenx

given: Michel

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Vaylet

full_name: Fabien Vaylet

given: Fabien

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Herman

full_name: Dominique Herman

given: Dominique

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Tredaniel

full_name: Jean Tredaniel

given: Jean

family: Ducoloné

full_name: Alain Ducoloné

given: Alain

family: Lebitasy

full_name: Marie-Paule Lebitasy

given: Marie-Paule

family: Baudrin

full_name: Laurence Baudrin

family: Laporte

full_name: Silvy Laporte

given: Silvy

family: Milleron

full_name: Bernard Milleron

given: Bernard

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Villefranche-Sur-Saône - Hôpital Nord-Ouest

location_facility: Saint-Priest - Institut de Cancérologie de la Loire

location_facility: Quint-Fonsegrives - Clinique de la Croix du Sud

location_facility: Nancy - Institut de Cancérologie de Lorraine


title: Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis

acronym: KlebsieLCR

summary: Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. More recently, cases of hepatic abscess and acute community meningitis related to strains of Klebsiella pneumoniae have been reported. The mortality of these infections is important, most often due to a delayed diagnosis. The poor prognostic factors reported in the literature for very low numbers are: advanced age, coma, septic shock, glyceryachia <10mg / dL and proteinuria> 750 mg / dL. In addition, no study has specifically focused on the factors of occurrence and factors associated with Klebsiella sp. Indeed, meningitis related to Klebsiella pneumoniae seems to be a rare but probably underestimated event whose risk factors, clinical presentation, microbiological are little known and the treatment modalities of this severe infection are not codified.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility:
CHU Rennes
CHU Strasbourg
CHU Poitiers
Groupe Hospitalier Paris Saint-Joseph
CHU Caen
Hôpital Necker Enfants Malades
CHU Reims
Hôpital Sainte Anne
CHU Lyon
CHU Kremlin Bicetre
Hôpital Cochin
CHU Tours
Hôpital henri Mondor
CHU Nantes
CHU Nice
Hôpital Foch
CHU Brest
Hôpital Lariboisière


title: A Prospective Study Assessing Whether Immunoscore Colon Test Impacts the Choice of Adjuvant Chemotherapy, in a Multidisciplinary Meeting, for Treating Non-metastatic Colon Cancer Patients After Curative-intent Surgery

acronym: PROSCORE

summary: Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision.

status: Withdrawn

primary_purpose: Diagnostic

ReferenceCitation: Pagès F, Mlecnik B, Marliot F, Bindea G, Ou FS, Bifulco C, Lugli A, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Börger E, Hartmann A, Geppert C, Kolwelter J, Merkel S, Grützmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Léonard D, Remue C, Wang JY, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson EK, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Fredriksen T, Buttard B, Angelova M, Vasaturo A, Maby P, Church SE, Angell HK, Lafontaine L, Bruni D, El Sissy C, Haicheur N, Kirilovsky A, Berger A, Lagorce C, Meyers JP, Paustian C, Feng Z, Ballesteros-Merino C, Dijkstra J, van de Water C, van Lent-van Vliet S, Knijn N, Mușină AM, Scripcariu DV, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Torigoe T, Sato N, Furuhata T, Takemasa I, Itoh K, Patel PS, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Sargent DJ, Fox BA, Galon J. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018 May 26;391(10135):2128-2139. doi: 10.1016/S0140-6736(18)30789-X. Epub 2018 May 10.

intervention_type: Diagnostic Test

status_simplified: Unknown


ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

family: Conroy

full_name: Thierry Conroy

given: Thierry

family: Desseigne

full_name: Françoise Desseigne

given: Françoise

family: Ychou

full_name: Marc Ychou

given: Marc

family: Bouché

full_name: Olivier Bouché

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

family: Bécouarn

full_name: Yves Bécouarn

given: Yves

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: Raoul

full_name: Jean-Luc Raoul

given: Jean-Luc

family: Gourgou-Bourgade

full_name: Sophie Gourgou-Bourgade

given: Sophie

family: de la Fouchardière

full_name: Christelle de la Fouchardière

given: Christelle

family: Bachet

full_name: Jean-Baptiste Bachet

given: Jean-Baptiste

family: Khemissa-Akouz

full_name: Faiza Khemissa-Akouz

given: Faiza

family: Péré-Vergé

full_name: Denis Péré-Vergé

family: Delbaldo

full_name: Catherine Delbaldo

given: Catherine

family: Assenat

full_name: Eric Assenat

given: Eric

family: Chauffert

full_name: Bruno Chauffert

given: Bruno

family: Michel

full_name: Pierre Michel

given: Pierre

family: Montoto-Grillot

full_name: Christine Montoto-Grillot

given: Christine

family: Ducreux

full_name: Michel Ducreux

journal_name: New England Journal of Medicine

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer

location_facility:
CH du Cotentin
Hôpital Saint-Joseph
Hôpital Nord Franche Comté
CHU La Timone
Hôpital Broussais
Institut Curie
CH de Bayeux
Centre Antoine Lacassagne
Hôpital Européen de Marseille
Hospices civils de Lyon
Hôpital Trousseau
Hôpital Saint-Louis
Centre Eugène Marquis
Hôpital Pitié-Salpétrière
Institut Paoli Calmettes
Institut Godinot
Institut Gustave Roussy
Institut Mutualiste Montsouris
Centre Léon Bérard
Institut de Cancérologie de l'Ouest
CHU de Saint-Etienne
Centre Georges François Leclerc
CHU Jean Minjoz
Hôpital Duchenne
CH Simone Veil
CHU Rouen

title: A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma

summary: This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.


title: BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation

summary:
Blinatumomab (BLINCYTO) is a bi-specific T-cell engaging (BiTE®) antibody construct that transiently links CD3-positive T cells to CD19-positive B-cells, inducing T-cell activation and subsequent lysis of tumor cells.

The investigators propose to evaluate the efficacy, safety and tolerability of blinatumomab administered after R-CHOP debulking therapy in patients with Richter Syndrome (RS) of diffuse large B-cell lymphoma (DLBCL) histology.

The investigators hypothesize that 8-week blinatumomab induction therapy leads to Complete Response (CR) rate improvement (revised Cheson criteria) from a baseline of 7percent as observed in the prospective study evaluating R-CHOP.

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: Institut Paoli-Calmettes - Hématologie Clinique

location_facility: Hôpitaux de Brabois - Hématologie Adulte

location_facility: Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent

location_facility: CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Hôpital Robert Debré - Hématologie Clinique

location_facility: Hôpital Avicenne - Centre de Recherche Clinique

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire


title: OPEN LABEL PHASE 2 STUDY ON THE EFFICACY AND TOLERANCE OF A COMBINATION OF PONATINIB AND 5-AZACITIDINE IN CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE OR IN MYELOID BLAST CRISIS - PONAZA TRIAL

acronym: PONAZA

summary:
This project is strategy aiming to improve the survival of patients with chronic myelogenous leukemia in advanced phase and myeloid blast crisis.

The basis of this strategy is to add the demethylating agent 5-Azacitidine to the tyrosine kinase inhibitor ponatinib and evaluate its activity in 2 cohorts of patients with either chronic myelogenous leukemia in advanced phase or myeloid blast crisis.

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Institut Universitaire Du Cancer Toulouse

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Centre Hospitalier Universitaire D'Amiens

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Regional Universitaire de Lille


title: A Phase III Randomized Trial Evaluating Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer (GRECCAR - PRODIGE - FRENCH)

summary:
GRECCAR 15 is focused on Locally Recurrent Rectal Cancer (LRRC) for patients with previous pelvic radiotherapy for the primary rectal cancer. This situation leads to a 20% higher risk of non-curative resection for the LRRC management (R1 status) impacting significantly the overall survival. The widespread use of neoadjuvant radiotherapy for primary rectal cancer introduces this new problem: the treatment of LRRC in previously irradiated area.

The objective of GRECCAR 15 is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.

ReferenceType: derived

ReferenceCitation: Denost Q, Frison E, Salut C, Sitta R, Rullier A, Harji D, Maillou-Martinaud H, Rullier E, Smith D, Vendrely V; on behalf the GRECCAR Group. A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as preoperative treatment for locally recurrent rectal cancer - GRECCAR 15 trial protocol. Colorectal Dis. 2021 Jul;23(7):1909-1918. doi: 10.1111/codi.15670. Epub 2021 Jun 10.

name: Département de Chirurgie Colorectal Hôpital Haut‐Lévèque CHU Bordeaux France

family: Denost

full_name: Quentin Denost

given: Quentin

name: Inserm CIC1401‐EC, Bordeaux Service D’information Médicale CHU Bordeaux France

family: Frison

full_name: Eric Frison

name: Service de Radiologie Hôpital Haut‐Lévèque CHU Bordeaux France

family: Salut

full_name: Cécile Salut

given: Cécile

family: Sitta

full_name: Remy Sitta

given: Remy

name: Service d’Anatomopathologie Hôpital Pellegrin CHU Bordeaux France

family: Rullier

full_name: Anne Rullier

given: Anne

family: Harji

full_name: Deena Harji

given: Deena

family: Maillou‐Martinaud

full_name: Helene Maillou‐Martinaud

given: Helene

full_name: Eric Rullier

name: Service D’oncologie Hôpital Haut‐Lévèque CHU Bordeaux France

family: Smith

full_name: Denis Smith

given: Denis

name: Radiotherapy Department Haut‐Lévèque Hospital CHU Bordeaux France

family: Vendrely

full_name: Veronique Vendrely

given: Veronique

journal_name: Colorectal Disease

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as preoperative treatment for locally recurrent rectal cancer – GRECCAR 15 trial protocol

location_facility: Hôpital Européen Georges Pompidou - APHP


title: PALbociclib in Advanced Breast Cancer: Therapy INtegrating locorEgional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients

acronym: PALATINE

summary:
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease in mortality in Europe and North America due to early detection and access to treatment, breast cancer remains the 2ⁿᵈ leading cause of cancer deaths in developed countries after lung cancer and the world's leading cause.

In the ESME French national retrospective cohort (NCT03275311), the newly diagnosed estrogen receptor (ER)-positive and HER2-negative (luminal) metastatic patients had a 59.1 months overall survival (OS) for pre-menopausal women and 44.7 months for postmenopausal women. In the same cohort, the median OS was 47.4 months for de novo metastatic patients with hormone receptor (HR)-positive / HER2-negative breast cancer.

The most important current treatment for metastatic breast cancer remains systemic therapy. Surgery and radiation are mainly used to treat symptoms. However, more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS. These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy. Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor.

Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results. This can be explained by a limited power of statistical analysis, on the recruitment of patients with breast cancer of all types, and on a limited access to effective systemic therapies in some cases and all before the area of anti CD4/6 which is the current standard treatment in patients with HR-positive / HER2-negative luminal metastatic disease.

However, guidelines indicate that a "multimodal approach, including curative locoregional treatments, should be considered". As a result, many clinicians offer locoregional treatment of the primary tumor, especially if there is a good response to the first line of systematic treatment.

Taken together, these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK4/6 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive / HER2-negative breast cancer.

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


title: Phase II Trial of Trastuzumab in Combination With Pertuzumab in Pretreated Patients With Non-small Cell Lung Cancer (NSCLC) Harboring a Her2 Mutation and Receiving Docetaxel

summary: HER2 (erbB-2/neu) is a member of the erbB receptor tyrosine kinase family. ERBB2 gene which encodes human epidermal growth factor 2 (HER2) is a major proliferative driver activating downstream signaling through PI3K-AKT and MEK-ERK. HER2 overexpression or gene amplification is associated with sensitivity to trastuzumab and lapatinib in breast cancer. Among actual lung cancer biomarker, HER2 remains apart. HER2 involvement is known for a long time but clinical research has been stopped for many years since the first clinical trials in unselected patients were negative. Recently trastuzumab + pertuzumab + docetaxel has been tested for first-line treatment of HER2-positive metastatic breast cancer (CLEOPATRA trial). Analysis of the primary end point showed that patients who received pertuzumab, trastuzumab, and docetaxel (pertuzumab group) had a significantly longer median progression-free survival, as assessed by independent reviewers an did those who received placebo, trastuzumab, and docetaxel (control group) (hazard ratio favoring the pertuzumab group, 0.62). There is thus a strong rational for treating HER2 mutated lung cancer patient with these drugs.

location_facility:
Centre Hospitalier - Pneumologie
Lyon - URCOT
CHU Strasbourg
CHU Toulouse
CHI Créteil
AP-HP Hopital Tenon - Pneumologie
CHU de Nantes
CHU de Bordeaux
Montpellier - CHRU
Gustave Roussy
Hôpital Nord APHM
CHRU Grenoble
CHU Besançon
Rennes - CHU
Clermont-Ferrand - CHU
Caen - CHU Côte de Nacre
Nice CLCC
AP-HP Hôpital Bichat


title: Adolescent Depression Associated With Parental Depression : Screening, Prevalence and Secondary Prevention From the Meeting of Depressed Parents on Primary Care

acronym: AdoDesP

summary:
Depression is difficult to identify, prevent and treat in adolescents because of complex and stigmatized multiform symptoms and pathways of care.

In children the existence of a parental depression is a significant and recognized risk factor for the development of a depression. It is regularly reported that 30% of adolescents of depressed parents have depression themselves. General Practitioners (GP) have significant access to the depression of adults, potentially parents of teenagers. In fact, 20% of patients in the regular active file of one GP have depression. The primary health care system could provide indirect but voluminous and unprecedented access to the identification of adolescent depression at an early stage from the encounter of depressed parents.

The difficulties of articulation between primary care (PC) and mental health devices are demonstrated. They disrupt the care pathways of adolescents detected in PC, prevention, and may even disturb early detection of depression. An organized joint between the PC and a specialized mental health service for adolescents ("Maison Des Adolescents" MDA) could promote the process of screening and preventing depression of adolescents of depressed parents encountered in PC.

In addition, if the effects of parental depression on adolescents are established, they remain complex and interactive. They vary by age and sex of the child but also the sex of the parent. A concomitant study of adolescent and parent depression will provide data to analyze the prevalence of depressed parent adolescent depression and to define risk or protection factors.

AdoDesP study is a cluster randomised trial (randomisation of the GPs) which compare a group of adolescent with PC articulated with mental health service (MDA) and an other group without articulation (routine cares).

A third group of depressed adolescents will be constituted to analyse parental depression of depressed adolescents.

lead_sponsor: University Hospital, Brest

location_facility:
Dr Le Grignou
Dr Phan
Dr Coat-Gourio
Dr Monnier
Dr CONNAN
Dr CHIRON
Dr Magueres
Dr Le Goff
Dr CAMILLERI
Dr Ben Yahmed
Dr Volant-Le-Berre
Dr Ac'h
Dr Andro-De-Schotten
Dr GLOANEC
Dr MOUDEN
Dr Wauters
Dr Crenn-Corvez
Dr Beck-Robert
Dr Cazuguel
Dr MAZE
Dr Gasnier
Dr PITMAN


title: A Randomized Non-comparative Phase II Study of Maintenance Therapy With OSE2101 Plus FOLFIRI, or FOLFIRI After Induction Therapy With FOLFIRINOX in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (TEDOPaM-D17-01 PRODIGE 63 Study)

acronym: TEDOPAM

summary: TEDOPAM is a randomized (1.1.1) non-comparative phase II study. This study will assess the efficacy and safety of OSE2101 alone or in combination with nivolumab followed by FOLFIRI reintroduction, versus FOLFIRI as maintenance therapy in patients with advanced PDAC after induction therapy with FOLFIRINOX.

location_facility: Hôpital Lyon Sud Hospices Civils de Lyon


title: Personalized Medicine for Membranous Nephropathy

acronym: PMMN

summary:
Randomized, open label, multicentre (20 sites), prospective trial comparing the efficacy of two therapeutic strategies to obtain clinical remission 1 year after diagnosis of Idiopathic Membranous Nephropathy with nephrotic syndrome and anti-PLA2R1 (phospholipase A2 receptor 1) antibodies:

GEMRITUX protocol: 6 months of symptomatic antihypertensive and antiproteinuric therapy, and if the nephrotic syndrome persists at month-6 (urinary protein/creatinine ratio (UPCR) remains > 3.5 g/g and albuminemia < 30 g/l), two 375 mg/m2 rituximab infusions at 1-week interval.

Personalized treatment:

restricted anti-CysR activity at inclusion : 6-month symptomatic antihypertensive and antiproteinuric treatment (KDIGO)
restricted anti-CysR activity after 6 months of symptomatic treatment with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 375 mg/m2 rituximab infusions at 1-week interval;
Anti-CTLD (C-type lectin domains ) 1/7 activity at inclusion or after 6 months with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 1g rituximab infusions at 2-week interval at month 0 and/or month 6.

ReferenceCitation: Simon N, Couroucé AM, Lemarrec N, Trépo C, Ducamp S. A twelve year natural history of hepatitis C virus infection in hemodialyzed patients. Kidney Int. 1994 Aug;46(2):504-11.

ReferenceCitation: Simon P, Ramee MP, Boulahrouz R, Stanescu C, Charasse C, Ang KS, Leonetti F, Cam G, Laruelle E, Autuly V, Rioux N. Epidemiologic data of primary glomerular diseases in western France. Kidney Int. 2004 Sep;66(3):905-8.

ReferenceCitation: Ponticelli C. Membranous nephropathy. J Nephrol. 2007 May-Jun;20(3):268-87. Review.

ReferenceCitation: Glassock RJ. The pathogenesis of idiopathic membranous nephropathy: a 50-year odyssey. Am J Kidney Dis. 2010 Jul;56(1):157-67. doi: 10.1053/j.ajkd.2010.01.008. Epub 2010 Apr 8. Review.

ReferenceCitation: Lassalle M, Ayav C, Frimat L, Jacquelinet C, Couchoud C; Au Nom du Registre REIN. The essential of 2012 results from the French Renal Epidemiology and Information Network (REIN) ESRD registry. Nephrol Ther. 2015 Apr;11(2):78-87. doi: 10.1016/j.nephro.2014.08.002. Epub 2014 Nov 1.

family: Lassalle

full_name: Mathilde Lassalle

given: Mathilde

family: Ayav

full_name: Carole Ayav

given: Carole

family: Frimat

full_name: Luc Frimat

given: Luc

family: Jacquelinet

full_name: Christian Jacquelinet

given: Christian

family: Couchoud

full_name: Cécile Couchoud

journal_name: Néphrologie & Thérapeutique

ReferenceCitation: Brglez V, Boyer-Suavet S, Zorzi K, Fernandez C, Fontas E, Esnault V, Seitz-Polski B. Personalized Medicine for PLA2R1-Related Membranous Nephropathy: A Multicenter Randomized Control Trial. Front Med (Lausanne). 2020 Aug 13;7:412. doi: 10.3389/fmed.2020.00412. eCollection 2020.

family: Brglez

full_name: Vesna Brglez

given: Vesna

family: Boyer-Suavet

full_name: Sonia Boyer-Suavet

given: Sonia

family: Zorzi

full_name: Kévin Zorzi

given: Kévin

family: Fernandez

full_name: Céline Fernandez

given: Céline

family: Fontas

full_name: Eric Fontas

family: Esnault

full_name: Vincent Esnault

given: Vincent

family: Seitz-Polski

full_name: Barbara Seitz-Polski

given: Barbara

currency_apc_doaj: USD

journal_name: Frontiers in Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
AP-HM
CHU de Caen
CHRU de LILLE
CHU de NANTES
Hôpital Necker
CHU Henri Mondor
CHU Carémeau
Le Kremlin Bicêtre
CHU D'amiens Hôpital Sud
CHU Gabriel Montpied
CHRU de Montpellier
CHU de Strasbourg
CHU de Tours
Dr Barbara SEITZ-POLSKI
Hôpital universitaire La Cavale Blanche
CHU Besançon
CHU de LYON NORD
Hôpital de la maison blanche
CHU de Toulouse