acronym: STAR

summary: The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.

location_facility:
Bichat Hospital
La Pitié-Salpétrière
Lyon Sud Hopsital
Strasbourg Hospital
Saint-Etienne Hospital
Pasteur Hospital
Bicêtre Hospital
Limoges Hospital
Brest University Hospital
Lille Hospital
Montpellier Hospital
Clermont-Ferrand Hospital
Orléans Hospital
Jean Rougier Hospital
Cochin Hospital
Hospital Pierre-Paul Riquet
Bordeaux University Hospital

title: Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.

type: Other Grant/Funding Number

region: Occitanie

nom_etablissement: CHU TOULOUSE

acronyme: STAR

titre: Comparaison de deux stratégies d'arrêt de la corticothérapie générale dans la polyarthrite rhumatoïde (PR) en bas niveau d'activité ou en rémission

discipline_principale: rhumatologie

nom_porteur: RUYSSEN WITRAND

prenom_porteur: Adeline


type: Other Identifier

title: Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria

acronym: SPIDAC

summary: Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections - especially upper and lower respiratory tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in adults. The current European and US guidelines advocate screening adults for PIDs if they present recurrent benign especially upper and lower respiratory tract infections, or if they have experienced at least two severe bacterial infections and/or have a recurrent need for intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in adult patients who present such recurrent infections and/or after the first severe bacterial infection, especially when the patients do not present with known, etiologically relevant comorbidities.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: University Hospital, Lille

collaborators: Laboratoire français de Fractionnement et de Biotechnologies

location_facility:
Ch Dunkerque
Hopital Prive La Louviere
CHRU,
CH ARRAS
Ch Tourcoing
Clinique Teissier
Ch Denain
Ch Cambrai
CH DOUAI
Ch de Valenciennes
Ch Region de St-Omer
Ch Boulogne-Sur-Mer
CH LENS
Hopital Saint Vincent - Saint Antoine
Ch Armentieres
Groupe Hospitalier Seclin Carvin
Ch Arrondissement de Montreuil
C.H de Roubaix
Ch Bethune

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Unknown


study_start_date_type: Actual

acronym: OPTIMA

intervention_type: Drug

lead_sponsor: Actelion

summary: The purpose of the study is to document the effect of first line dual oral combination therapy with macitentan 10mg and tadalafil 40mg on pulmonary vascular resistance (PVR) in treatment-naïve patients with newly diagnosed pulmonary arterial hypertension (PAH).

location_facility:
Hôpital Jean Minjoz
Hôpital Bretonneau
Hôpital Timone Adultes
Hôpital Côte de Nacre
CHU Site du Bocage
Hôpital Civil
Hôpital Arnaud de Villeneuve
Hôpital Pontchaillou
Hôpital Dupuytren
Hôpital Nord
Hôpital Louis Pradel
Hôpital Albert Michallon
Hôpital Larrey
Hôpital Bicètre
CHR La Miletrie
Hôpital de Haut Levêque
Hôpital Charles Nicolle
Hôpital Robert Debré

title: Prospective, Multicenter, Open-label Study Evaluating the Effects of First-line Oral Combination Therapy of Macitentan and Tadalafil in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (OPTIMA).

primary_purpose: Treatment

source: euctr

lead_sponsor_type: industriel


acronym: Transition II

lead_sponsor: Sanofi

summary:
Primary Objective:

The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement.

Secondary Objectives:

Evolution of fasting plasma glucose
Evolution of insulin dose and body weight
Hypoglycemia incidence
Safety
Patients satisfaction when they change their insulin for HOE901-U300

location_facility:
Investigational Site Number 250037
Investigational Site Number 250055
Investigational Site Number 250046
Investigational Site Number 250008
Investigational Site Number 250070
Investigational Site Number 250082
Investigational Site Number 250028
Investigational Site Number 250086
Investigational Site Number 250051
Investigational Site Number 250019
Investigational Site Number 250026
Investigational Site Number 250063
Investigational Site Number 250083
Investigational Site Number 250059
Investigational Site Number 250104
Investigational Site Number 250031
Investigational Site Number 250007
Investigational Site Number 250002
Investigational Site Number 250029
Investigational Site Number 250076
Investigational Site Number 250084
Investigational Site Number 250072
Investigational Site Number 250013
Investigational Site Number 250048
Investigational Site Number 250033
Investigational Site Number 250098
Investigational Site Number 250100
Investigational Site Number 250061
Investigational Site Number 250067
Investigational Site Number 250022
Investigational Site Number 250052
Investigational Site Number 250102
Investigational Site Number 250073
Investigational Site Number 250107
Investigational Site Number 250062
Investigational Site Number 250018
Investigational Site Number 250027
Investigational Site Number 250023
Investigational Site Number 250047
Investigational Site Number 250054
Investigational Site Number 250030
Investigational Site Number 250004
Investigational Site Number 250035
Investigational Site Number 250010
Investigational Site Number 250032
Investigational Site Number 250087
Investigational Site Number 250034
Investigational Site Number 250078
Investigational Site Number 250042
Investigational Site Number 250024
Investigational Site Number 250005
Investigational Site Number 250105
Investigational Site Number 250093
Investigational Site Number 250069
Investigational Site Number 250064
Investigational Site Number 250020
Investigational Site Number 250103
Investigational Site Number 250092
Investigational Site Number 250071
Investigational Site Number 250012
Investigational Site Number 250081
Investigational Site Number 250058
Investigational Site Number 250068
Investigational Site Number 250021
Investigational Site Number 250060
Investigational Site Number 250050
Investigational Site Number 250075
Investigational Site Number 250039
Investigational Site Number 250053
Investigational Site Number 250057
Investigational Site Number 250095
Investigational Site Number 250006
Investigational Site Number 250101
Investigational Site Number 250108
Investigational Site Number 250041
Investigational Site Number 250001
Investigational Site Number 250096
Investigational Site Number 250044
Investigational Site Number 250090
Investigational Site Number 250089
Investigational Site Number 250056
Investigational Site Number 250088
Investigational Site Number 250017
Investigational Site Number 250065
Investigational Site Number 250043

status: Completed

title: An Interventional, Open-label, Single-arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin

type: EudraCT Number

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

ipd_sharing: Yes

status_simplified: Completed


title: Randomized Multicenter, Phase III Trial Evaluating the Safety of 2 Schedules of Cabazitaxel (Bi-weekly Versus Tri-weekly) Plus Prednisone in Elderly Men (≥ 65years) With mCRPC Previously Treated With a Docetaxel-containing Regimen

acronym: CABASTY

summary: The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Pobel C, Auclin E, Procureur A, Clement-Zhao A, Simonaggio A, Delanoy N, Vano YA, Thibault C, Oudard S. Cabazitaxel schedules in metastatic castration-resistant prostate cancer: a review. Future Oncol. 2021 Jan;17(1):91-102. doi: 10.2217/fon-2020-0672. Epub 2020 Dec 2.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Future Science Ltd

ipd_sharing: No

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_country: Germany France

location_facility: Urologie und Kinderurologie Marienkrankenhaus Bergisch

location_facility: Uniklinik Köln, Urologie, Uro-Onkologie, spezielle urologische und Roboter-assistierte Chirurgie

location_facility: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie,

location_facility: Universitäts-klinik für Urologie und Kinderurologie


acronym: ProtoTOP

lead_sponsor: Air Liquide Santé International

summary: To assess the effect of 3 consecutive days of one-hour administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical air), in add-on therapy to chronic analgesic treatments, on average pain intensity in patients with chronic peripheral neuropathic pain. A total of 250 randomised patients to be included in all the participating centres, i.e., 125 randomised patients in each of the 2 study groups treatments

ReferenceCitation: Bouhassira D, Perrot S, Attal N, Ramirez-Gil JF, Delval C, Schaller M, Bessiere B, Houeto P, Sommer C. Combination of inhaled nitrous oxide and oral opioids induces long-lasting analgesic effects in patients with neuropathic pain: ProtoTOP study post hoc exploratory analyses. Pain. 2022 Sep 1;163(9):e1021-e1029. doi: 10.1097/j.pain.0000000000002570. Epub 2021 Dec 20.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Bouhassira D, Perrot S, Riant T, Martine-Fabre G, Pickering G, Maindet C, Attal N, Ranque Garnier S, Nguyen JP, Kuhn E, Viel E, Kieffert P, Tolle T, Delorme C, Deleens R, Ginies P, Corand-Dousset V, Dal-Col C, Serrie A, Chevrillon E, Gov C, Ramirez-Gil JF, Delval C, Schaller M, Bessiere B, Houeto P, Sommer C; ProtoTOP group. Safety and efficacy of an equimolar mixture of oxygen and nitrous oxide: a randomized controlled trial in patients with peripheral neuropathic pain. Pain. 2021 Apr 1;162(4):1104-1115. doi: 10.1097/j.pain.0000000000002109.

sponsor_collaborators:
Air Liquide Santé International
AMS Advanced Medical Services GmbH

location_facility: Centre hospitalier Universitaire de Rouen

location_facility: Neurologische Klinik Klinikum rechts der Isar

location_facility: Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz

location_facility: Centre Hospitalier Universitaire Gabriel Montpied

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Centre Hospitalier Régional de Metz-Thionville

title: Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) for the Treatment of Peripheral Neuropathic Pain: A Randomises, International, Multicentre, Placebo-Controlled, Phenotype-stratified Phase IIa Study


title: The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years

summary: The registry aims to compare the two first-line available treatment approaches in non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in terms of practitioner's choice between the two options, clinical effectiveness and cost-effectiveness, long-term outcome, and short- and long-term toxic effects.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Teva Pharmaceuticals USA

location_facility: CHU Hôpital Sud - service Hémato-oncologie Pédiatrique


title: OBSERVATOIRE NATIONAL D'UTILISATION D'INFLECTRA™ EN VIE RÉELLE.

acronym: ReFLECT

summary:
National, prospective, multicentre observational study designed for eligible patients treated with Inflectra.

Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.

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: Hopital Robert Debre, Service d'Hepato-gastro-enterologie et de Cancerologie Digestive

location_facility: Centre Hospitalier de Cannes Hopital Pierre Nouveau

location_facility: Centre Hospitalier de Montpellier Hopital Saint Eloi

location_facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre

location_facility: Centre Hospitalier Regional de Besancon, Service de Gastrologie

location_facility: Service de rhumatologie - CHU Nantes, Hopital Hotel Dieu

location_facility: Hopital Robert Debre, Service D'Hepato-gastro-enterolo

location_facility: Centre Hospitalier de Lille Hopital Roger Salengro

location_facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

location_facility: Centre Hospitalier Estaing, Service de Medicine Interne

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Centre Hospitalier Carcassonne, Service de Rhumatologie

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

location_facility: Centre Hospitalier de Cholet Service d'Hépato-Gastro-Entérologie

location_facility: Fondation Maison Sante Bagatelle, Gastro Enterologie

location_facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

intervention_type: Other


title: Eltrombopag for the Treatment of Thrombocytopenia Due to Low- and Intermediate Risk Myelodysplastic Syndromes (EQoL-MDS)

summary:
Myelodysplastic syndromes (MDS) prevail in older age and are characterized by ineffective erythropoiesis and peripheral cytopenias. Supportive therapy is the main therapeutic option for most patients. Quality of Life (QoL) is mainly deteriorated by anemia and by the limitations associated with thrombocytopenia, neutropenia and transfusion dependence. The only available treatment for severe thrombocytopenia, in the presence of bleeding, is platelet transfusion.

Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. In adult patients with chronic immune thrombocytopenia (ITP), Eltrombopag rapidly increases platelet counts and significantly reduces bleeding episodes during treatment. Eltrombopag is well tolerated. In 2007, Eltrombopag has received the Orphan Drug Designation for the treatment of ITP (EMEA/OD/031/07), and in 2008 the Food and Drug Association approved Eltrombopag for the treatment of ITP refractory or resistant. It has been shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic colonies. These results provide the rationale for pursuing further research on Eltrombopag for the treatment of thrombocytopenia in case of MDS.

The study is open to adult patients with myelodysplastic syndrome (MDS) with thrombocytopenia and low- or intermediate-1 IPSS risk (Index Prognostic Score System).

Severe thrombocytopenia associated with MDS may lead to death from hemorrhage, even in low prognostic risk patients. The benefit of platelet transfusion is short-termed. Patients become refractory in the long term. The availability of a treatment that induces the increase of platelet count is extremely important, either in terms of quality of life, and in overall survival.

status: Active, not recruiting

lead_sponsor: Associazione Qol-one

location_country: Germany Italy Slovenia France

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: A.O. SS. Antonio e Biagio e Cesare Arrigo

location_facility: U.O. Citta' della Salute e della Scienza di Torino

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: A.O.U. San Giovanni di Dio e Ruggì D'Aragona

location_facility: A.O. Citta' della Salute e della Scienza di Torino

status_simplified: Ongoing


title: Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

summary:
Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical evaluation is performed using PMR-AS.

The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit until the end of the study, depending on response to treatment and PMR-AS.

primary_purpose: Supportive Care

ReferenceCitation: Devauchelle-Pensec V, Carvajal-Alegria G, Dernis E, Richez C, Truchetet ME, Wendling D, Toussirot E, Perdriger A, Gottenberg JE, Felten R, Fautrel BJ, Chiche L, Hilliquin P, Le Henaff C, Dervieux B, Direz G, Chary-Valckenaere I, Cornec D, Guellec D, Marhadour T, Nowak E, Saraux A. Effect of Tocilizumab on Disease Activity in Patients With Active Polymyalgia Rheumatica Receiving Glucocorticoid Therapy: A Randomized Clinical Trial. JAMA. 2022 Sep 20;328(11):1053-1062. doi: 10.1001/jama.2022.15459.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Roche Chugai

location_facility: Hopital Nord service de rhumatologie-Franche Comté

appel_a_projets: PHRCN

region: Bretagne

nom_etablissement: CHRU BREST

type_etablissement: CHUR

acronyme: SEMAPHORE

titre: Tolérance et Efficacité du tocilizumab versus placebo dans la Pseudo Polyarthrite Rhizomélique corticorésistante

nom_porteur: DEVAUCHELLE PENSEC

prenom_porteur: Valérie


title: Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice

acronym: MIROIR

summary:
This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry.

This study will add to the registry. Indeed, pomalidomide-prescribing physicians and pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who have been prescribed this drug since the date on which it was marketed regardless of the initiation date of pomalidomide or the indication for which it was prescribed.

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Waldschmidt JM, Simon A, Wider D, Muller SJ, Follo M, Ihorst G, Decker S, Lorenz J, Chatterjee M, Azab AK, Duyster J, Wasch R, Engelhardt M. CXCL12 and CXCR7 are relevant targets to reverse cell adhesion-mediated drug resistance in multiple myeloma. Br J Haematol. 2017 Oct;179(1):36-49. doi: 10.1111/bjh.14807. Epub 2017 Jul 2.

ReferenceCitation: Dinner S, Dunn TJ, Price E, Coutre SE, Gotlib J, Berube C, Kaufman GP, Medeiros BC, Liedtke M. A phase I, open-label, dose-escalation study of amrubicin in combination with lenalidomide and weekly dexamethasone in previously treated adults with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Sep;108(3):267-273. doi: 10.1007/s12185-018-2468-5. Epub 2018 May 25.

ReferenceCitation: Garderet L, Kuhnowski F, Berge B, Roussel M, Escoffre-Barbe M, Lafon I, Facon T, Leleu X, Karlin L, Perrot A, Moreau P, Marit G, Stoppa AM, Royer B, Chaleteix C, Tiab M, Araujo C, Lenain P, Macro M, Voog E, Benboubker L, Allangba O, Jourdan E, Orsini-Piocelle F, Brechignac S, Eveillard JR, Belhadj K, Wetterwald M, Pegourie B, Jaccard A, Eisenmann JC, Glaisner S, Mohty M, Hulin C, Loiseau HA, Mathiot C, Attal M. Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma. Blood. 2018 Dec 13;132(24):2555-2563. doi: 10.1182/blood-2018-07-863829. Epub 2018 Oct 3.

evidence: open (via free article)

publisher_dissemination: American Society of Hematology

ReferenceCitation: Mark TM, Forsberg PA, Rossi AC, Pearse RN, Pekle KA, Perry A, Boyer A, Tegnestam L, Jayabalan D, Coleman M, Niesvizky R. Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. Blood Adv. 2019 Feb 26;3(4):603-611. doi: 10.1182/bloodadvances.2018028027.

ReferenceCitation: Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.

ReferenceCitation: Li Y, Wang X, Liu L, Zhang C, Gomez D, Reyes J, Palmisano M, Zhou S. An Open-Label, Phase 1 Study to Assess the Effects of Hepatic Impairment on Pomalidomide Pharmacokinetics. Clin Pharmacol Drug Dev. 2019 Apr;8(3):346-354. doi: 10.1002/cpdd.470. Epub 2018 May 10.

lead_sponsor: Celgene

location_facility: Centre Hospitalier Intercommunal Robert Ballanger

location_facility: Hopital Nord Franche-Comte - Site de Belfort


title: The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest

acronym: CP-GARO

summary: Intra-aortic Balloon Pumps (IABP) have been used for roughly 50 years in Critical Care Units, Intensive Care Units, Cath labs as a way to improve systemic and coronary circulation in patients in cardiogenic shock (CS) or at high risk situation as mechanical complications stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc. Several papers recently questioned the relevance of this assistance device - namely the IABP-SHOCK II trial in CS and the CRISP-AMI trial in anterior MI without CS - resulting in the downgrading of the recommendation standards of the IABP by medical societies.

lead_sponsor: Rennes University Hospital

location_facility: Communauté Hospitalière de Territoire Rance Emeraude

location_facility: Groupement Coopération Sanitaire Pui Cite Sanitaire


title: Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission

acronym: FIBROTHERME

summary: This study evaluates the dermatological life quality six months after spa cares in patients with severe late toxicity involving the skin and / or soft tissues after postoperative radiotherapy for breast cancer. Half of the patients will be treated with a combination of pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive skin-oriented spa cares in addition.

study_start_date_type: Anticipated

lead_sponsor: Institut de Cancérologie de Lorraine

collaborators: Association Francaise pour la Recherche Thermale

location_facility: CH de Belfort-Montbéliard Site du Mittan

location_facility: Clinique du Parc de Charleville-Mézières

location_facility: Centre d'Oncologie et de Radiothérapie du Parc


title: A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate (Glivec®) Plasmatic Through Level in Patients Newly Diagnosed With Chronic Phase Chronic Myelogenous Leukaemia (CP-CML).

acronym: OPTIMIMATINIB

summary:
Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. The optimal IM daily dose is not yet determined and randomized studies addressing this question are on-going. First results from the TOPS trial (EHA 2008 congress) suggest a more rapid kinetic of response for patients treated with imatinib high dose. Recent studies revealed that initial Imatinib plasmatic dosage is predictive for achieving complete cytogenetic responses (CCR) and that a dosage of 1000 ng/ml is associated with a higher proportion of major molecular responses (MMR) (Picard et al., Blood 2007, Larson et al. Blood 2007).

Results from the study of Larson et al. indicate that around 40% of the patients had a trough plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major molecular response rate at 12 months for the patients with the lower plasmatic through level is 25.4% compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.

Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort 1) versus observation only (cohort 2). The patients with adequate imatinib dosage (> 1000 ng/ml) will be followed up according the ELN recommendation (cohort 3). Imatinib trough plasmatic level will then be rechecked every month thereafter for patients in cohort 1 and cohort 2 and every three months in cohort 3. The first endpoint of the study will be the rate of major molecular response at 12 months in cohort 1. Our hypothesis is to improve the 12 months MMR rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to 40% of MMR at 12 months.

lead_sponsor: Versailles Hospital

location_facility:
Hopital Bon secours
CHU CAEN
CH Boulogne
CHU Nice
CHU Rennes
Hopital Purpan
CHU Lyon
CH argenteuil
CH d'Annecy
CHU angers
Hopital La Source
Hopital Necker
CH Dunkerque
CH Versailles
CH Meaux
CH de Dieppe
Institut Bergonié
CHU Bordeaux
CHU Lille


title: Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

acronym: STIM-FU

summary: It's an observational study based on 98 patients included in the STIM trial to extend the monitoring of patients and to have molecular and clinical data, with long follow up. Are there late relapses? What has become patients who relapsed during STIM trial and restarted TKI (inhibitor tyrosine kinase) treatment?

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Purpan
Hôpital Morvan
CHU de Poitiers
CHU Hôtel-Dieu
Hôpital Edouard Herriot
CHU de Bordeaux - Haut-Lévêque
Hôpital Civil
CHU Brabois
Pôle de cancérologie
CHU d'Angers
Centre Hospitalier de La Roche Sur Yon
Institut Paoli Calmette
CHU de Nice
Centre Hospitalier de Versailles
Hôpital Necker-Enfants Malades
Institut Bergonié
Hôpital Saint Louis
Hôpital Henri-Mondor
Hôpital Claude Huriez

intervention_type: Behavioral


title: Phase II Study to Evaluate the Efficacy of Upfront Obinutuzumab in Mantle Cell Lymphoma Patients Treated by DHAP Followed by Autologous Transplantation Plus Obinutuzumab Maintenance Then MRD Driven Maintenance

summary: This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront obinutuzumab in mantle cell lymphoma patients treated by Cisplatinum-Cytarabine-Dexamethasone (DHAP) followed by autologous transplantation plus obinutuzumab maintenance then Molecular Residual Disease (MRD) driven maintenance

ReferenceCitation: Le Gouill S, Beldi-Ferchiou A, Alcantara M, Cacheux V, Safar V, Burroni B, Guidez S, Gastinne T, Canioni D, Thieblemont C, Maisonneuve H, Bodet-Milin C, Houot R, Oberic L, Bouabdallah K, Bescond C, Damaj G, Jaccard A, Daguindau N, Moreau A, Tilly H, Ribrag V, Delfau-Larue MH, Hermine O, Macintyre E. Molecular response after obinutuzumab plus high-dose cytarabine induction for transplant-eligible patients with untreated mantle cell lymphoma (LyMa-101): a phase 2 trial of the LYSA group. Lancet Haematol. 2020 Nov;7(11):e798-e807. doi: 10.1016/S2352-3026(20)30291-X. Epub 2020 Sep 21.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Bailly C, Carlier T, Berriolo-Riedinger A, Casasnovas O, Gyan E, Meignan M, Moreau A, Burroni B, Djaileb L, Gressin R, Devillers A, Lamy T, Thieblemont C, Hermine O, Kraeber-Bodere F, Le Gouill S, Bodet-Milin C. Prognostic value of FDG-PET in patients with mantle cell lymphoma: results from the LyMa-PET Project. Haematologica. 2020 Jan;105(1):e33-e36. doi: 10.3324/haematol.2019.223016. Epub 2019 Aug 1. No abstract available.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

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 - Université de Nantes

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
CHU Lyon Sud
CHU de Poitiers
I.U.C.T Oncopole
CHU Limoges
CHU d'Amiens
APHP - Hopital Necker
CHU de Haut Leveque
CH Perpignan
CHU de Strasbourg
Institut de Cancérologie de Loire
CHU de Dijon - Hôpital le Bocage
CHRU Bretonneau
CHU d'Angers
CHU Robert Debré
CHU de Brabois
Centre Hospitalier Annecy-Genevois
CHU Nantes
CHU Montpellier
CH d'Avignon
CHU Pontchaillou
CHU de Grenoble
Clinique Victor Hugo
CHU de Caen
Hôpital Saint Louis
CHD Vendée
Gustave Roussy Cancer Campus
Hopital Henri Mondor
CHRU Lille - Hôpital Claude Huriez
Centre Henri Becquerel
CHU de Clermont Ferrand


title: Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer

acronym: RORC

summary:
Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Recently, many retrospective studies and two evidence-based and systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward benefit for a preventive swallowing exercise program.

The main hypothesis of this study is that an early active swallowing therapy can improve the Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.

The study will be a randomized controlled, open-label, multicentric phase III clinical trial comparing early active swallowing therapy versus non specific swallowing management (usual care).

location_facility:
Lyon University Hospital
Nantes University Hospital
Poitiers University Hospital
Lille University Hospital
Caen University Hospital
Bretagne Sud Hospital
Toulouse University Hospital
Marseille University Hospital
Strasbourg University Hospital
Institut Gustave Roussy
Centre Alexis Vautrin
Clermont-Ferrand University Hospital
Clinique La Sagesse
Centre Antoine Lacassagne
Tours University Hospital
Bretagne Atlantique Hospital
Brest University Hospital
Rennes University Hospital
Centre François Baclesse
Le Mans Hospital
Tenon Hospital


title: Interest of Implantable Cardioverter-defibrillator in Primary Prevention in Patient With Continuous Flow Left Ventricular Assist Device (CF-LVAD)

acronym: ASSIST-ICD

summary: Determination of risk factors of ventricular arrhythmias (VAs) after implantation of continuous flow left ventricular assist device in order to characterize which patient requires ICD implantation in primary prevention.

ReferenceCitation: Charton M, Flecher E, Leclercq C, Delmas C, Dambrin C, Goeminne C, Vincentelli A, Michel M, Lehelias L, Verdonk C, Para M, Pozzi M, Obadia JF, Boignard A, Chavanon O, Barandon L, Nubret K, Kindo M, Minh TH, Gaudard P, Pelce E, Gariboldi V, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Bourguignon T, Genet T, Eschalier R, D'Ostrevy N, Bories MC, Jouan J, Vanhuyse F, Blangy H, Doucerain J, Martins RP, Galand V. Suicide Attempts Among LVAD Recipients: Real-Life Data From the ASSIST-ICD Study. Circulation. 2020 Mar 17;141(11):934-936. doi: 10.1161/CIRCULATIONAHA.119.041910. Epub 2020 Mar 10. No abstract available.

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

version: submittedVersion

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

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

ReferenceCitation: Galand V, Flecher E, Auffret V, Pichard C, Boule S, Vincentelli A, Rollin A, Mondoly P, Barandon L, Pernot M, Kindo M, Cardi T, Gaudard P, Rouviere P, Senage T, Jacob N, Defaye P, Chavanon O, Verdonk C, Ghodbane W, Pelce E, Gariboldi V, Pozzi M, Obadia JF, Savoure A, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Pierre B, Bourguignon T, Eschalier R, D'Ostrevy N, Bories MC, Marijon E, Vanhuyse F, Blangy H, Verhoye JP, Leclercq C, Martins RP. Early Ventricular Arrhythmias After LVAD Implantation Is the Strongest Predictor of 30-Day Post-Operative Mortality. JACC Clin Electrophysiol. 2019 Aug;5(8):944-954. doi: 10.1016/j.jacep.2019.05.025. Epub 2019 Aug 19.

oa_colors: green hybrid

evidence: open (via crossref license)

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

ReferenceCitation: Martins RP, Leclercq C, Bourenane H, Auffret V, Boule S, Loobuyck V, Dambrin C, Mondoly P, Sacher F, Bordachar P, Kindo M, Cardi T, Gaudard P, Rouviere P, Michel M, Gourraud JB, Defaye P, Chavanon O, Kerneis C, Ghodhbane W, Pelce E, Gariboldi V, Pozzi M, Grinberg D, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Pierre B, Bourguignon T, Eschallier R, D'Ostrevy N, Bories MC, Jouan J, Vanhuyse F, Sadoul N, Flecher E, Galand V. Incidence, predictors, and clinical impact of electrical storm in patients with left ventricular assist devices: New insights from the ASSIST-ICD study. Heart Rhythm. 2019 Oct;16(10):1506-1512. doi: 10.1016/j.hrthm.2019.06.021. Epub 2019 Jun 27.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

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

ReferenceCitation: Tattevin P, Flecher E, Auffret V, Leclercq C, Boule S, Vincentelli A, Dambrin C, Delmas C, Barandon L, Veniard V, Kindo M, Cardi T, Gaudard P, Rouviere P, Senage T, Jacob N, Defaye P, Chavanon O, Verdonk C, Para M, Pelce E, Gariboldi V, Pozzi M, Grinberg D, Savoure A, Litzler PY, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Bernard L, Bourguignon T, Eschalier R, D'Ostrevy N, Jouan J, Varlet E, Vanhuyse F, Blangy H, Martins RP, Galand V. Risk factors and prognostic impact of left ventricular assist device-associated infections. Am Heart J. 2019 Aug;214:69-76. doi: 10.1016/j.ahj.2019.04.021. Epub 2019 May 6.

ReferenceCitation: Galand V, Flecher E, Auffret V, Boule S, Vincentelli A, Dambrin C, Mondoly P, Sacher F, Nubret K, Kindo M, Cardi T, Gaudard P, Rouviere P, Michel M, Gourraud JB, Defaye P, Chavanon O, Verdonk C, Ghodbane W, Pelce E, Gariboldi V, Pozzi M, Obadia JF, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Radu C, Pierre B, Bourguignon T, Eschalier R, D'Ostrevy N, Bories MC, Marijon E, Vanhuyse F, Blangy H, Verhoye JP, Leclercq C, Martins RP; ASSIST-ICD Investigators. Predictors and Clinical Impact of Late Ventricular Arrhythmias in Patients With Continuous-Flow Left Ventricular Assist Devices. JACC Clin Electrophysiol. 2018 Sep;4(9):1166-1175. doi: 10.1016/j.jacep.2018.05.006. Epub 2018 Jul 25.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel


title: Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated

summary: Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.

status: Recruiting

design_allocation: Non-Randomized

lead_sponsor: Institut Curie

location_facility:
Chu Saint Etienne
Chu de Grenoble
Chu Angers
CHU CAEN
Centre Leon Berard
Hopital D'Enfants La Timone
Chu Nancy
Chu de Poitiers
Chu Limoges
Institut Curie
Chu Nantes
Chu de Rennes
Chu R; Pellegrin
Chu Morvan
Centre Oscar Lambret
Chu Toulouse
Chu de Nice
Chr Felix Guyon
Hopital Arnaud de Villeneuve
Chur de Reims
Hoptial Hautepierre
Chu Estaing
Hopital Nord Chu Amiens
Chu de Rouen
Chu Tours
Chu Bocage
Hopital Jean Minioz


acronym: EFESE

summary:
Despite advances in early detection and treatment strategy, about 25 to 40% of patients treated for breast cancer develop metastasis.

Some patients are in a therapeutic impasse situation. It is therefore necessary to consider all possible options. The Estramustine showed encouraging results in the treatment of metastatic breast cancer.

Given the clinical data, the answer rate of Estramustine and its impact on progression free survival deserve to be studied in earlier clinical situation.

This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and metastates, already treated with aromatase inhibitors and for whom this treatment has failed.

location_facility:
CHRU Brest
Hôpital Européen Georges Pompidou
Institut Sainte Catherine
CLCC Léon Bérard
Hôpital Privé Clairval
Polyclinique de Blois
Clinique armoricaine
Centre Paul Strauss
CHBM Site du Mittan
Institut Jean Godinot
CHU Besançon-Jean Minjoz
Institut de Cancérologie de Lorraine
CHU Tenon
Centre Antoine Lacassagne
CLCC Val d'Aurel
Clinique Sainte Anne
Centre Catherine de Sienne
Centre O. Lambret
CHU Avicenne
Polyclinique Courlancy Reims
Polyclinique Bordeaux Nord Aquitaine


title: Apomorphine Pump in Early Stage of Parkinson's Disease

acronym: EARLY-PUMP

summary: The aim of the study is to assess the use of the apomorphine pump in earlier stages of Parkinson' Disease (PD), when motor complications have just developed and before patients are significantly affected in their social and occupational functioning. The investigators hypothesize that apomorphine pump is superior in terms of positive impact on quality of life (QoL) to oral medical therapy alone at a relatively early stage of PD, before the appearance of severe disabling motor complications thus favoring the maintain of patients' social and occupational status with a significant positive economic impact of the health system.

location_facility:
Pierre Wertheimer Hospital
Caremeau University Hospital
Hautepierre University Hospital
Poitiers University Hospital
Lille University Hospital
Saint-Etienne University Hospital
Caen University Hospital
Clinique Beau-Soleil
Montpellier University Hospital
Nancy University Hospital
Amiens University Hospital
Bayonne Côte Basque Hospital
Clermont-Ferrand University Hospital
Pellegrin University Hospital
Pitié-Salpêtriere Hospital
Rennes University Hospital
Laennec Hospital
Purpan University Hospital
Pasteur 2 University Hospital
APHM, hospital of Timone

nom_etablissement: CHRU RENNES

acronyme: EARLY PUMP

titre: Étude de l'efficacité de la Pompe à Apomorphine dans la maladie de Parkinson au stade précoce de la maladie

discipline_principale: neurologie

nom_porteur: DRAPIER

prenom_porteur: Sophie


title: Identification of Genetic Markers Modulating Rhythmic Risk Among Patients With Severe Cardiomyopathy

acronym: GENECHOC

summary: The aim of this project is to identify common genetic polymorphisms associated with the occurrence of rhythmic events in patients with severe cardiomyopathy.

time_perspective: Other

lead_sponsor: Nantes University Hospital

location_facility:
CHU Nancy
CHU Nantes
CHU Grenoble
CHU Montpellier
CH La Rochelle
CHU Toulouse
CHU Lyon
CHU Tours
CHU Rennes
CHRU Lille
CHRU Strasbourg
CHU Bordeaux
CHU Brest
CHU Dijon
CHU Rouen
CHU Marseille
CHU Angers
CHU Clermont-Ferrand.

intervention_type: Genetic


title: An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in Females Presenting With Operable Breast Cancer

summary: This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. The participants will receive 4 cycles of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin + Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85). After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast surgery with regional lymph node dissection will be performed, followed within a maximum of 6 weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period, participants will enter the post-treatment follow-up period which will last for 5 years from the initial date of participant randomization. During this period participants will be evaluated once a year on the anniversary date of randomization.

lead_sponsor: Hoffmann-La Roche


title: Cost-utility Evaluation of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma: Perineal Filling With Biological Meshes vs. Primary Perineal Wound Closure

summary: Abdominoperineal resection performed for anorectal tumors leaves a large pelvic and perineal defect causing a high rate of morbidity of the perineal wound (40 - 60 %). Biological meshes offer possibility for a new standard of perineal wound reconstruction. Perineal filling with biological mesh is expected to increase quality of life by reducing perineal morbidity.

ReferenceCitation: Buscail E, Canivet C, Ghouti L, Kirzin S, Carrere N, Molinier L, Rosillo A, Lauwers-Cances V, Costa N; French Research Group of Rectal Cancer Surgery (GRECCAR Group). Randomised clinical trial for the cost-utility evaluation of two strategies of perineal reconstruction after abdominoperineal resection in the context of anorectal carcinoma: biological mesh repair versus primary perineal wound closure, study protocol for the GRECCAR 9 Study. BMJ Open. 2021 Apr 1;11(4):e043333. doi: 10.1136/bmjopen-2020-043333.

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

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Toulouse

location_facility:
Clermont-Ferrand University Hospital
Institut de Cancérologie de Lorraine
Nancy University Hospital
Saint-Antoine Hospital
Lyon University Hospital
Nantes University Hospital
University Hospital of Toulouse
Angers University Hospital
Besançon University Hospital
Grenoble University Hospital
CHRU Lille
Rouen University Hospital
Amiens University Hospital
Caen University Hospital
Centre Oscar Lambret
Paoli Calmettes Institut
Bordeaux University Hospital

intervention_type: Procedure

appel_a_projets: PRMEK

type_etablissement: CH

titre: GRECCAR 9: Cost-utility evaluation of two strategies of perineal reconstruction after abdominoperineal resection for anorectal carcinoma: perineal filling with biological meshes vs. primary perineal wound closure.

discipline_principale: low anorectal tumours

nom_porteur: KIRZIN

prenom_porteur: Sylvain


title: " Endarterectomy Combined With Optimal Medical Therapy Versus Optimal Medical Therapy Alone in Patients With Asymptomatic Severe Atherosclerotic Carotid Artery Stenosis at Higher-than-average Risk of Ipsilateral Stroke "

acronym: ACTRIS

summary: The purpose of this study is to determine whether carotid surgery combined with optimal medical therapy improves long-term survival free of ipsilateral stroke in patients with asymptomatic carotid stenosis at higher-than-average risk of ipsilateral stroke when compared with optimal medical therapy alone.

status: Not yet recruiting

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier St Anne

collaborators: Hôpitaux Universitaires Paris Ile-de-Franc Ouest

location_facility: Centre Hospitalier régional de Besançon, Hôpital Jean Minjoz

location_facility: Centre Hospitalier Bichat-Claude Bernard

location_facility: CHU de Toulouse Hôpital Pierre-Paul Riquet

location_facility: CHU Bordeaux, Groupe Hospitalier Pellegrin

location_facility: Hôpital Neurologique Pierre Wertheimer GHE

location_facility: CHU de Strasbourg, Hôpital de Hautpierre

region: Île-de-France

nom_etablissement: GHU PARIS PSY ET NEUROSCIENCES

type_etablissement: EPSM

acronyme: ACTRIS

titre: Endartèrectomie associée à un traitement médical optimal versus traitement médical optimal seul chez des patients ayant une sténose carotide athéroscléreuse serrée asymptomatique à haut risque d'infarctus cérébral ipsilatéral.

nom_porteur: MAS

prenom_porteur: Jean Louis


title: Observational Multicenter Cohort Study of French Patients With a Central or Combined Syndrome of Sleep Apnea With a Predominant Central SAS Treated by Adaptive Servo-Ventilation

acronym: FACIL-VAA

summary: The main goal of this French multicenter observational cohort study is to prospectively collect data assessing the impact of the Adaptative Servo-Ventilation treatment on the quality of sleep of patients with central or combined sleep apnea syndrome (SAS) out of Heart Failure (HF) with altered ejection fraction, with a predominant central SAS.

ipd_sharing_description: oversight committee

lead_sponsor: Société Française de Recherche et de Médecine du Sommeil

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Groupe Hospitalier Public du Sud de l'Oise

location_facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

location_facility: Hôpital Arnaud de Villeneuve CHU de Montpellier

intervention_type: Device


title: NADIR: Multicentre, Open-Label Trial Evaluating a Simple NeoRecormon Regimen in Anemic Patients With Diabetes and Chronic Kidney Disease (Stage 2 to 5) Who Are Not on Dialysis

summary: This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and quality of life in participants with diabetes and chronic renal failure and who are not receiving dialysis.


title: Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years

acronym: CAC-CBC

summary: Assessment of the concordance of the initial clinical and histological diagnosis and to explore its prognostic impact in terms of risk of recurrence.

sponsor_collaborators:
University Hospital, Bordeaux
Société de Dermatologie Française

location_facility: University Hospital of Bordeaux - Hospital Saint André

location_facility: Tranchand (Dermatologue - Le Puy En Velay)

location_facility: Groupe Hospitalier de L'Institut Catholique de Lille


acronym: BEVANEC

lead_sponsor: Hospices Civils de Lyon

summary:
Poorly differentiated neuroendocrine carcinomas (NEC) are a sub-group of aggressive neuroendocrine neoplasms (NEN). The most common primary sites are broncho-pulmonary and digestive. The gastroentero-pancreatic NECs (GEP-NEC) represent 7-21% of all of the NENs.

Recent data on the initial presentation of GEP-NEC have been reported in two retrospective studies and a French cohort study. No standard second-line treatment has been defined for NECs. Despite a very negative prognosis, these NECs have a certain amount of chemosensitivity, close to that of bronchial NECs. Multiple-drug therapies such as Folfiri, or Folfox, or single drug treatments such as temozolomide are the proposed options but with a low level of proof Bevacizumab associated with a cytotoxic chemotherapy has shown promising results in well differentiated neuroendocrine tumors (NET), known for being hypervascular. The efficacy of bevacizumab has also been suggested in patients with NEC, but never in the context of a phase II study. Its combination with Folfiri is efficient and well tolerated in metastatic colorectal cancer. The combination Folfiri-bevacizumab potentially represents an optimized treatment compared to chemotherapy with only Folfiri. No phase II or III studies have reported results for these patients, and no on-going phase II or III trial have been identified to date.

The main objective of this study is to show that, after the failure of a first-line chemotherapy using platinum-etoposide, the combination Folfiri-bevacizumab allows significant prolongation of overall survival in adult patients with GEP-NEC.

location_facility: Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Européen Georges Pompidou, APHP

location_facility: Département d'Oncologie Médicale, Hôpital Saint-Antoine

location_facility: Service d'Oncologie Endocrinienne, Institut Gustave Roussy

location_facility: Service de Gastroentérologie et Pancréatologie, Hôpital Beaujon, APHP

location_facility: Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Sud, CHU d'Amiens

location_facility: Service d'Hépato-Gastroentérologie et Oncologie Digestive, CHU de Dijon

location_facility: Service d'Hépatogastroentéologie, Hôpital Michallon, CHU de Grenoble

location_facility: Département de Cancérologie Urologique et Digestive, Centre Oscar Lambret

location_facility: Service de Gastroentérologie, Hôpital Cochin, APHP

location_facility: Service de Gastroentérologie, CHU de Rouen

location_facility: Service de Gastroentérologie, CHU Henri Mondor

location_facility: Département d'Oncologie Médicale, Institut Paoli Calmettes

location_facility: Service d'Oncologie Médicale, Hôpital Civil, CHU de Strasbourg

location_facility: Service d'Hépatogastroentérologie, CHU d'Angers

location_facility: Service de Gastroentérologie et Oncologie Digestive, Hôpital Avicenne

location_facility: Service d'Hépatogastroentérologie, Hôpital Pontchaillou, CHU de Rennes

location_facility: Service d'Oncologie Médicale, Hôpital Saint Eloi, CHU de Montpellier

location_facility: Département de cancérologie médicale - Groupe des tumeurs endocrines, Centre Léon Bérard

location_facility: Service d'Oncologie Médicale - Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Service de Gastro-Entérologie, Hôpital Nord, CHU de ST-Etienne

location_facility: Service d'Hépatogastroentérologie, CHR d'Orléans

location_facility: Service d'Hépato-Gastroentérologie et Cancérologie, Hôpital Robert Debré, CHU de Reims

location_facility: Service d'Oncologie et Radiothérapie, Institut Sainte Catherine

location_facility: Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital Haut Lévêque, CHU Bordeaux

location_facility: Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital de la Timone, APHM

location_facility: Pôle Régional de Cancérologie, CHU de Poitiers

title: Assessment of the Efficacy of Bevacizumab in Combination With Folfiri as Second-line Treatment After the Failure of the Cisplatin (or Carboplatin)-Etoposide Combination in Patients Suffering From an Advanced Inoperable Poorly Differentiated Neuroendocrine Carcinoma of an Unknown or Gastroentero-pancreatic Primary Cancer. A Phase 2 Non-comparative Randomized Study

appel_a_projets: PHRCK

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: BEVANEC

titre: Evaluation de l'efficacité du bevacizumab associé à du Folfiri en deuxième ligne après échec de l'association cisplatine (ou carboplatine)  étoposide chez des patients atteints d'un carcinome neuroendocrine peu différencié avancé inopérable. Etude de phase 2 randomisée.

discipline_principale: gi oncology

nom_porteur: WALTER

prenom_porteur: Thomas


lead_sponsor: UNICANCER

summary:
OBJECTIVES OF THE TRIAL

Primary objective

Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations.

Secondary objectives

To assess toxicity
To assess response rate
To assess overall survival
To assess time to progression
To study the correlation between response rate, time to progression, overall survival and biological parameters

location_facility:
Pitie Salpetriere
Centre Rene Gauducheau
Chu de Nimes
Centre Hospitalier Lyon Sud
Hopitaux Universitaires
Diaconesses - Croix St Simon
Institut Bergonie
Institut Claudius Regaud
Institut Gustave Roussy
Institut Cancerologie de La Loire
Centre Leon Berard
Institut Curie
Hopital Henri Mondor
Hopital Saint Andre
Institut Paoli Calmettes
Centre Alexis Vautrin
Centre Francois Baclesse

title: Intensified Methotrexate, Vinblastine, Doxorubicin and Cisplatin +/-Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma in Patients Without Harvey Nor Kirsten Rat Sarcoma Viral Oncogene Homolog Mutations. Phase II Study


title: Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment

acronym: ADNCirc

summary:
Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect recurrences or metastases, a surveillance strategy is recommended for patients able to withstand complementary treatment during a five-year period. Over this period, the probability of one false-positive result is 87%. Considering that less than 10% of recurrent patients are suitable for potentially curative treatment and that more intensive programs enable an increase of the overall rate of curative resection but do not result in reduced mortality, less time and cost-consuming, tailored follow-up is necessary. The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance.

Tubes for ccfDNA analysis will be taken during medical examination at the same time of the CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for analysis in the laboratory INSERM (National Health Institute) of Montpellier and the remaining plasma will be kept in biological collection.

Patients will have a consultation of follow-up every 3-4 months during which the dosage of CEA and ccfDNA will be realized as well as a medical examination, a general examination (weight, size, and blood pressure), an evaluation of the indices of performance status and a nutritional evaluation in case of loss of weight.

ipd_sharing_description: the data are anonymized

lead_sponsor: University Hospital, Limoges

location_facility:
La marche clinical
Bergonie institute
Cahors Hospital
Sainte feyre Hospital
Saint Junien Hospital
Montpellier University Hospital
Brive Hospital
Montpellier Institute
Périgueux Hospital
Vichy Hospital
Saint Antoine AP-HP
Gueret Hospital
Perigueux clinical
Clermont Ferrand University Hospital
Les Cèdres clinical
Bordeaux University Hospital
Limoges Hospital
Moulins Hospital
Aurillac Hospital


title: Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study

acronym: EVALYMPH

summary: Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis. The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Hôpital Saint Louis-Lariboisière CHU PARIS 5

location_facility: Centre de Lutte contre le Cancer, TOULOUSE

location_facility: Hôpital La pitié-Salpetrière CHU PARIS 3


title: Candidate Therapies in Combination or Sequentially With Tyrosine Kinase Inhibitors in Chronic Phase-chronic Myelogenous Leukemia Patients in CCR Without Achieving a Deep Molecular Response: an Adaptative Trial Based on a Drop Loser Design

acronym: ACTIW

summary:
Patients will be randomized in phase II trials to continue on the same TKI versus one of the alternative treatment approaches. If a patient is not eligible for one of the treatments, he (she) will be randomized between the options for which he (she) is eligible.

The trial will start with current available treatment options (experimental arms). New available treatment options may be open at any times later on. Authorized TKIs are imatinib, nilotinib, dasatinib, bosutinib and ponatinib.

For all options the treatment duration is for a minimum of 12 months and will be continued in the absence of adverse events following investigator decision. Each therapeutic option will be detailed in term of combination modalities, dose, dose adaptation, specific warnings, specific exclusion and inclusion criteria. The decision to introduce a new option will depend on the general pace of recruitment and on the assessment of the potential efficacy and safety of the new treatment, and will be implemented after scientific review by a protocol amendment.

Primary objective:

A. To select molecules in combination or sequentially with imatinib, nilotinib, dasatinib, bosutinib or ponatinib potentially able to produce a 25% increase in the Cumulative Incidence of MR4.5 as compare to control.

Secondary objectives:

A. To determine the safety of selected therapies

B. To determine the rate of MR4 by 12, 24, 36, 48 months in experimental and control arms

C. To determine the rates of MR4.5 by 24, 36, 48 months in experimental and control arms

D. To determine the rate of undetectable BCR-ABL1 transcript (sensitivity 40000 ABL copies) by 12, 24, 36, 48 months in experimental and control arms

E. To estimate treatment free remission (TFR) in patients eligible for discontinuation studies

F. To investigate the relationship between biological activity and the clinical efficacy of the selected therapies

G. To assess the effects of the treatments on the number and clonogenicity of CML stem cells and other biological markers of interest

H. To estimate duration of response, progression-free survival, event free survival and overall survival.

location_facility:
Etienne
Pascale CONY.MAKHOUL
CHU de Rennes - Pontchaillou
Thorsten BRAUN
Martine GARDEMBAS
CHU Tours
Institut Universitaire contre le Cancer
CHU de LIMOGES
Franck NICOLINI
Delphine REA _St louis
Viviane DUBRUILLE
Institut P Calmette
Hopital l'Archet
CH Henri Mondor
Cayssials
Hôpital La Source
Hôpital René Huguenin
CHU Côte de Nacre
CHU Estaing
Simona LAPUSAN_St Antoine
CHU Lille
Eric JOURDAN
Rousselot

nom_etablissement: CENTRE HOSPITALIER  DE VERSAILLES

acronyme: ACTIW

titre: Molécules candidates en association ou en alternance avec les inhibiteurs de tyrosine kinase chez les patients atteints de leucémie myéloide chronique en phase chronique (LMC-PC) en réponse cytogénétique complète et n'ayant pas atteint un niveau de réponse moléculaire profonde : Essai clinique adaptatif à élimination séquentielle.

discipline_principale: hematologie / hematology

nom_porteur: ROUSSELOT

prenom_porteur: Philippe


title: Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury

acronym: OXY-TC

summary:
Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and its intensity is directly related to the neurological outcome. The thresholds for irreversible tissue damage following TBI indicate a particular vulnerability of injured brain. Improving brain oxygenation after severe TBI is the focus of modern TBI management in the intensive care unit (ICU).

The calculation of cerebral perfusion pressure (CPP), with CPP = mean arterial pressure (MAP) - intracranial pressure (ICP), has become the most used estimator of cerebral blow flow. To prevent ischemia due to elevated ICP, current international guidelines recommend maintaining CPP at 60-70 mmHg and ICP below 20 mmHg. However, episodes of brain hypoxia/ischemia, as assessed with brain tissue oxygen pressure (PbtO2) measurements, might occur despite optimization of CPP and ICP, and have been independently associated with poorer patient outcome. PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an independent predictor of unfavorable outcome and death. The aggressive treatment of low PbtO2 was associated with improved outcome compared to standard ICP/CPP-directed therapy in cohort studies of severely head-injured patients. On the basis of these findings, it is hypothesized that an early optimization of brain oxygenation, together with keeping ICP and CPP within recommended values, could reduce the volume of vulnerable lesions following severe TBI and possibly improve neurological outcome.

ReferenceCitation: Cunningham AS, Salvador R, Coles JP, Chatfield DA, Bradley PG, Johnston AJ, Steiner LA, Fryer TD, Aigbirhio FI, Smielewski P, Williams GB, Carpenter TA, Gillard JH, Pickard JD, Menon DK. Physiological thresholds for irreversible tissue damage in contusional regions following traumatic brain injury. Brain. 2005 Aug;128(Pt 8):1931-42. doi: 10.1093/brain/awh536. Epub 2005 May 11.

ReferenceCitation: Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. IX. Cerebral perfusion thresholds. J Neurotrauma. 2007;24 Suppl 1:S59-64. doi: 10.1089/neu.2007.9987. No abstract available. Erratum In: J Neurotrauma. 2008 Mar;25(3):276-8. multiple author names added.

ReferenceCitation: Oddo M, Levine JM, Mackenzie L, Frangos S, Feihl F, Kasner SE, Katsnelson M, Pukenas B, Macmurtrie E, Maloney-Wilensky E, Kofke WA, LeRoux PD. Brain hypoxia is associated with short-term outcome after severe traumatic brain injury independently of intracranial hypertension and low cerebral perfusion pressure. Neurosurgery. 2011 Nov;69(5):1037-45; discussion 1045. doi: 10.1227/NEU.0b013e3182287ca7.

ReferenceCitation: van den Brink WA, van Santbrink H, Steyerberg EW, Avezaat CJ, Suazo JA, Hogesteeger C, Jansen WJ, Kloos LM, Vermeulen J, Maas AI. Brain oxygen tension in severe head injury. Neurosurgery. 2000 Apr;46(4):868-76; discussion 876-8. doi: 10.1097/00006123-200004000-00018.

ReferenceCitation: Stiefel MF, Spiotta A, Gracias VH, Garuffe AM, Guillamondegui O, Maloney-Wilensky E, Bloom S, Grady MS, LeRoux PD. Reduced mortality rate in patients with severe traumatic brain injury treated with brain tissue oxygen monitoring. J Neurosurg. 2005 Nov;103(5):805-11. doi: 10.3171/jns.2005.103.5.0805.

ReferenceCitation: Narotam PK, Morrison JF, Nathoo N. Brain tissue oxygen monitoring in traumatic brain injury and major trauma: outcome analysis of a brain tissue oxygen-directed therapy. J Neurosurg. 2009 Oct;111(4):672-82. doi: 10.3171/2009.4.JNS081150.

ReferenceCitation: Mistral T, Roca P, Maggia C, Tucholka A, Forbes F, Doyle S, Krainik A, Galanaud D, Schmitt E, Kremer S, Kastler A, Tropres I, Barbier EL, Payen JF, Dojat M. Automated Quantification of Brain Lesion Volume From Post-trauma MR Diffusion-Weighted Images. Front Neurol. 2022 Feb 23;12:740603. doi: 10.3389/fneur.2021.740603. eCollection 2021.

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

publisher_dissemination: Frontiers

ReferenceCitation: Payen JF, Richard M, Francony G, Audibert G, Barbier EL, Bruder N, Dahyot-Fizelier C, Geeraerts T, Gergele L, Puybasset L, Vigue B, Skaare K, Bosson JL, Bouzat P. Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol. BMJ Open. 2020 Aug 20;10(8):e040550. doi: 10.1136/bmjopen-2020-040550.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

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

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital of Paris-Salpetriere

nom_etablissement: CHU GRENOBLE ALPES

acronyme: OXY TC

titre: Impact de l'optimisation précoce de l'oxygénation cérébrale sur le volume des lésions cérébrales après traumatisme crânien grave

discipline_principale: anesthésiologie / réanimation

nom_porteur: PAYEN

prenom_porteur: Jean François


title: Frequency of Pompe's Disease and Neuromuscular Etiologies in Patients With Restrictive Respiratory Failure Associated With Signs of Muscle Weakness

summary:
A breach of respiratory function may be one of the elements more or less early or predominant clinical picture of neuromuscular diseases. It is considered that the obstructive syndromes represent 64% and restrictive or mixed syndromes 36% of chronic respiratory insufficiency, approximately 7% due to a neuromuscular disease. The frequency and type of impairment are dependent on the underlying pathology.

The neuromuscular restrictive respiratory failure (IRR) remains partially unknown pulmonologists, especially because the signs of muscle weakness are sometimes difficult to detect. However, respiratory diseases are a major concern in neuromuscular diseases because they can have an impact both on sleep (not sleep, ...) on the daily activities (breathlessness on exertion, dyspnea) and thereby alter the quality of life of patients. Moreover, they represent a significant morbidity and mortality factor. Chest tightness may in some cases reveal the disease and thus constitute the chief complaint of a patient with a neuromuscular disease. In late-onset Pompe disease, lung disease is the predominant clinical symptoms in about 30% of patients.

An algorithm was developed to guide practitioners and help them in their diagnostic approach to the cause of the IRR (diagnostic algorithm ATS / ERS 2005). However, this algorithm does not allow precise identification of the neuromuscular causes.

At the patient level, this can have an impact by extending the time before placing a diagnosis. In Pompe disease, the average time to diagnosis reached 7.9 years. However, there are for this disease a simple and rapid diagnostic test. Therefore, a greater awareness of practitioners with regard to the particular Pompe disease and neuromuscular diseases in general may be beneficial to patients.

This study aims to:

i) awareness pulmonologists to the possibility of neuromuscular an IRR.

ii) characterize the frequency of neuromuscular origin of IRR in a broad population of patients with concomitant signs muscle weakness.

iii) reduce the time to diagnosis by directing patients to neuromuscular reference center early.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de St Etienne
Hôpital Raymond Poincaré
CHI de Créteil
CHU de Rouen
Hôpital Tenon
CHU le Bocage
CHU de Toulouse
CH d'Escartons
CHRU de Lille
Polyclinique les Bleuets
CHU d'Angers
GH Pitié Salpêtrière
Cabinet Dr Pereira-Cortese
CH de Cannes
CHU de Nice
CHU de Brest
Centre hospitalier d'Argenteuil
Hôpital Saint Louis
CHU de Limoges
CHRU de Tours
Clinique Saint Joseph


title: Impact of a Simple Clinical Tool for Increasing Enrollment on a Kidney Transplant Waiting List for Patients Aged Over 70 and Initiating Dialysis

acronym: KITE

summary:
The main objective of this study is to show that the systematic use of a prognostic score as early as possible after the initiation of dialysis in patients over 70 years of age and with a good prognosis at 3 years of dialysis results in an increase in the number of entries on a kidney transplant waiting list at 12 months after the initiation of dialysis.

This prospective assessment is carried out as part of a historico-prospective before-after study in parallel with a survey of changes in national practices over the same time period via a here-elsewhere type study.

Historical data (i.e the. "before" period) will include incident dialysis cases during the calendar years 2013, 2014 and 2015 before the start of the prospective phase (i.e. "after" period, which is represented by the current declaration); since a preliminary study demonstrated that the data are comparable from 2011 to 2013, we will use the average of data thus obtained. Historical data will be retrieved from the REIN (The French Renal Epidemiology and Information Network) registry data and will be validated by investigators at each center.

primary_purpose: Screening

ReferenceCitation: Dusseux E, Albano L, Fafin C, Hourmant M, Guerin O, Couchoud C, Moranne O. A simple clinical tool to inform the decision-making process to refer elderly incident dialysis patients for kidney transplant evaluation. Kidney Int. 2015 Jul;88(1):121-9. doi: 10.1038/ki.2015.25. Epub 2015 Feb 11.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Intercommunal du Val d'Ariège

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Lapeyronie

location_facility: Centre d'Hemodialyse Languedoc Méditérranéen


title: Evaluation of Human HER-2 Status in Gastric and Gastro-Oesophageal Junction Cancer.

summary: The primary objective is to evaluate the concordance between human epidermal growth factor receptor 2 (HER2) status determined by the participating laboratory and by the centralized laboratory. HER2 status of samples was tested by the participating laboratories (investigator's choice of immunohistochemistry [IHC] and in situ hybridization [ISH] methods) and by the centralized laboratories (IHC using the 4B5 anti-HER antibody and Silver ISH). Positive HER2 status was defined as a score of IHC3+ or IHC2+/ISH+.

time_perspective: Cross-Sectional


title: Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements

acronym: CLINALK

summary: Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

ReferenceType: result

ReferenceCitation: Duruisseaux M, Besse B, Cadranel J, Perol M, Mennecier B, Bigay-Game L, Descourt R, Dansin E, Audigier-Valette C, Moreau L, Hureaux J, Veillon R, Otto J, Madroszyk-Flandin A, Cortot A, Guichard F, Boudou-Rouquette P, Langlais A, Missy P, Morin F, Moro-Sibilot D. Overall survival with crizotinib and next-generation ALK inhibitors in ALK-positive non-small-cell lung cancer (IFCT-1302 CLINALK): a French nationwide cohort retrospective study. Oncotarget. 2017 Mar 28;8(13):21903-21917. doi: 10.18632/oncotarget.15746.

evidence: open (via page says license)

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Impact Journals, LLC

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Vannes - Centre Hospitalier Bretagne Atlantique

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

location_facility: Paris - Hôpital Européen Georges Pompidou

location_facility: Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud


title: Randomized, Open Label Study to Evaluate Renal Safety of Intravenous Bondronat 6 mg Infusions Over 15 Minutes Versus 60 Minutes in Patients With Metastatic Bone Disease Due to Breast Cancer

summary: This study will evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate in the 2 groups of participants will also be compared. The anticipated time on study treatment is 7 months, and the target sample size is 318 individuals.


acronym: ACE-Lung

summary:
Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.

Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.

Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.

Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.

ReferenceCitation: Cortot AB, Madroszyk A, Giroux-Leprieur E, Molinier O, Quoix E, Berard H, Otto J, Rault I, Moro-Sibilot D, Raimbourg J, Amour E, Morin F, Hureaux J, Moreau L, Debieuvre D, Morel H, Renault A, Pichon E, Huret B, Charpentier S, Denis MG, Cadranel J. First-Line Afatinib plus Cetuximab for EGFR-Mutant Non-Small Cell Lung Cancer: Results from the Randomized Phase II IFCT-1503 ACE-Lung Study. Clin Cancer Res. 2021 Aug 1;27(15):4168-4176. doi: 10.1158/1078-0432.CCR-20-4604. Epub 2021 May 24.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

sponsor_collaborators: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Montpellier - GCS Centre de Cancérologie du Grand Montpellier

title: Phase II Study Evaluating the Combination of Cetuximab With Afatinib as First-line Treatment for Patients With EGFR Mutated Non Small Cell Lung Cancer


summary: The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s) would delay tumor progression in patients with unresectable MPM, experiencing disease progression after one or two lines of chemotherapy including at least first-line with pemetrexed and platinum, without altering significantly the quality of life of patients.

ReferenceCitation: Scherpereel A, Mazieres J, Greillier L, Lantuejoul S, Do P, Bylicki O, Monnet I, Corre R, Audigier-Valette C, Locatelli-Sanchez M, Molinier O, Guisier F, Urban T, Ligeza-Poisson C, Planchard D, Amour E, Morin F, Moro-Sibilot D, Zalcman G; French Cooperative Thoracic Intergroup. Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial. Lancet Oncol. 2019 Feb;20(2):239-253. doi: 10.1016/S1470-2045(18)30765-4. Epub 2019 Jan 16. Erratum In: Lancet Oncol. 2019 Mar;20(3):e132.

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

location_facility:
Toulouse - CHU Larrey
AP-HM Hôpital Nord
Dijon - CHU
CHU Tours - Pneumologie
Centre Hospitalier - Pneumologie
Gustave Roussy
AP-HP Hôpital Bichat
HCL Lyon Sud
Toulon - CHI
AP-HP Hopital Tenon - Pneumologie
CHU Strasbourg
Avignon - Institut Sainte-Catherine
Centre Etienne Dolet
Pontoise - CH
CHU
Rennes - CHU
Rouen - CHU
Mulhouse - CH
Grenoble - CHU
Angers - CHU
CHRU Lille - Hopital Calmette

title: A Randomized Phase II Study Evaluating Efficacy and Safety of 2nd or 3rd Line Treatment by Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients


title: A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents

summary:
A still major question in the field of acute lymphoblastic leukemia (ALL) in children - an extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the adolescents - is the optimal use of L-asparaginase (ASNase). It is known that administering ASNase results in the depletion of asparagine circulating in the blood, which starves the leukemic cells and results in their death. But indeed the use of ASNase varies between protocols considering the different brands, the dose and the administration modalities. Oncaspar (PEGylated E. coli asparaginase, pegaspargase) was thus developed with the goal of reducing the immunogenicity of the native ASNase.

This is a French prospective multicentric cohort study of children and adolescents with ALL, stratified on (i) the type of ALL ( B vs T) and (ii) the anticipated risk (stratified in 3 groups for childhood B-cell precursor (BCP)-ALL and 2 groups for T-cell ALL).

It aims to answer to two different issues:

Randomized question: what is the best way to administer pegaspargase? A cohort of children and adolescents with standard or medium risk ALL will be randomized to receive during induction either one infusion of ONCASPAR® 2500 IU/m2 at D12 or two infusions of ONCASPAR® at 1250 IU/m2 each at D12 and D26. Patients will then receive 2500 IU/m2 or 1250 IU/m2 per dose during consolidation and delayed intensification according to the initial arm of randomization.
Non randomized question: In the High/Very High Risk groups, a non randomized intensification of the scheme of asparaginase administration is proposed during induction therapy: 2 infusions of 2500 IU/m2/day (D12 and D26) will be administered. All patients will receive 2500 IU/m2 per dose during consolidation and delayed intensifications.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Shire

location_facility:
CHU
Chu-Ihope
CHu
CHU Armand Trousseau
CHRU
CHU Robert Debré
CHU Saint Louis


type: Registry Identifier

title: Low Level of Genomic Alteration to Predict Exceptional and Unexpected Response to Targeted Therapies in Patients With Solid Tumors

acronym: EXPRESS

summary: Adult patients with metastatic or locally advanced solid malignancies (including but not limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer, ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or having presented an exceptional and unexpected response to an antineoplastic targeted therapy.

primary_purpose: Other

location_facility: CHU de Poitiers - Pôle régional de Cancérologie

location_facility: Centre Hospitalier Annecy Genevois (CHANGE) - site d'Annecy

location_facility: Institut de Cancérologie de l'Ouest (site René Gauducheau)

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

location_facility: Hôpital Européen Georges Pompidou (HEGP)

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

location_facility: Institut de Cancérologie de l'Ouest (site Paul Papin)


title: Multicentre, Prospective, Randomized, Open-label Study Comparing the Efficacy and Safety of CellCept With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Standard Immunosuppression Comprising CellCept and Long-term Continuation of Cyclosporine in Renal Transplant Recipients Receiving Induction by Zenapax and Treated With Corticosteroids for 8 Months

summary: This multicentre, prospective, randomized, open-label study will compare the safety and efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, with those of mycophenolate mofetil and long term continuation of cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction treatment and followed by 8 month treatment with corticosteroids. The anticipated time on study treatment is 12 months. Participants who will complete the initial 12-month study and who will provide written informed consent will be eligible to participate in a 60-month follow-up phase.


title: Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring

acronym: SAVE

summary:
SAVE is a stratified cluster-randomised controlled, parallel group, open-label trial, with Epileptic Monitoring Unit (EMU) as the units of randomisation and patients as the unit of analysis.

The focus of research is the management of AntiEpileptic Drugs (AEDs) withdrawal during long term Video EEG (VEEG) monitoring in patients with drug resistant seizures. This non-standardised medical practice, which aims at promoting the occurrence of seizures during the time limit of the monitoring period, exposes patients to significant risks which should be minimised by harmonisation of practice and a standardised protocol of AEDs withdrawal.

SAVE will assess the impact of a standardised protocol of AEDs withdrawal during long-term VEEG monitoring on the frequency of seizure-related serious adverse events occurring during these monitorings and on the ability to obtain VEEG recording of seizures within appropriate time limits.

10 of the 22 EMUs will be randomised to the group where the standardised protocol of AEDs withdrawal will be used systematically, while the other ten EMUs will continue their current non-standardised practice of AEDs withdrawal, and will serve as a control group.

The setting of the study will include a 6 months evaluation phase, prior to randomisation, during which the organisational characteristics, baseline EMUs' activity, current management of AEDs withdrawal, and rate of Serious Adverse Events (SAEs) of each participating center will be evaluated.

The standardised study protocol of AEDs withdrawal has been defined on the basis of a systematic review of all relevant publications in the field.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

acronyme: SAVE

titre: Sevrage en médicaments Antiépileptiques et sécurité du monitoring Vidéo-EEG de longue durée.

nom_porteur: RHEIMS


title: Two Arm, Prospective, Multicenter Randomized Phase II Trial of Neoadjuvant Modified Folfirinox Regimen, With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma

summary: This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Polyclinique Bordeaux Nord
Institut Mutualiste Montsouris
Hôpital Cochin (APHP)
Centre Eugène Marquis
Hôpital Haut-Lévêque
Chru Nancy
Chu Nantes
Pitié Salpêtrière (APHP)
Hôpital La Timone
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Institut du Cancer de Montpellier
Institut de Cancérologie de Lorraine
Hôpital Paul Brousse
Hôpital Henri Mondor (APHP)
Institut Paoli CALMETTES
Infirmerie Protestante de Lyon
CHU Reims
Chu Colmar
Hôpital Européen Marseille
Chru Lille
Chu Rouen
Institut Bergonié
CHP Saint Grégoire
Chru Tours
Hôpital Beaujon

region: Grand Est

nom_etablissement: INSTITUT DE CANCEROLOGIE DE LORRAINE

type_etablissement: CLCC

titre: PANDAS (PRODIGE 44): Two arm, prospective, multicenter randomized phase II trial of neoadjuvant modified Folfirinox regimen, with or without preoperative concomitant chemoradiotherapy in patients with borderline resectable pancreatic carcinoma.

discipline_principale: cancer

nom_porteur: CONROY

prenom_porteur: Thierry


title: Amniotic Fluid Biomarker Research for Prediction of Postnatal Renal Function in Fetus With a Bilateral Abnormal Renal Development: National, Multicenter, Prospective and Non-interventional Study.

acronym: BIOMAN

summary:
The discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function? Ultrasound is insufficiently precise to predict postnatal renal function evolution.

The objective of this study is to estimate the specificity and sensitivity of amniotic fluid biomarkers to predict postnatal renal function in fetuses with bilateral developmental nephropathies.

Both fetuses with bilateral renal anomalies and control (healthy) fetuses will be included.

For this study amniotic fluid will only be collected according to routine clinical practice and only excess amniotic fluid sample will be used for the study.

The potentially identified biomarkers will not change routine management of the pregnancies in the study.

location_facility: Maison de Sante Protestante de Bagatelle/Bordeaux


title: Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)

summary:
The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:

NIV (Non Invasive Ventilation)
HFNC (High-flow nasal canula oxygen therapy)

ReferenceCitation: Rodriguez M, Ragot S, Coudroy R, Quenot JP, Vignon P, Forel JM, Demoule A, Mira JP, Ricard JD, Nseir S, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Merdji H, Petitpas F, Vivier E, Mekontso-Dessap A, Nay MA, Asfar P, Dellamonica J, Argaud L, Ehrmann S, Fartoukh M, Girault C, Robert R, Thille AW, Frat JP; REVA Network. Noninvasive ventilation vs. high-flow nasal cannula oxygen for preoxygenation before intubation in patients with obesity: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Jul 22;11(1):114. doi: 10.1186/s13613-021-00892-8.

publisher_dissemination: Springer-Nature

ReferenceCitation: Frat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, Mira JP, Coudroy R, Berquier G, Voisin B, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Clere-Jehl R, Petitpas F, Vivier E, Razazi K, Nay MA, Souday V, Dellamonica J, Argaud L, Ehrmann S, Gibelin A, Girault C, Andreu P, Vignon P, Dangers L, Ragot S, Thille AW; FLORALI-2 study group; REVA network. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18.

ReferenceCitation: Frat JP, Ricard JD, Coudroy R, Robert R, Ragot S, Thille AW; on-behalf-of REVA network. Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol. BMJ Open. 2017 Dec 22;7(12):e018611. doi: 10.1136/bmjopen-2017-018611.

lead_sponsor: Poitiers University Hospital

location_facility:
Hôpital C. NICOLLE
CHU La cavale Blanche
CHU louis MOURIER
Chu Tenon
Hopital de l'Archet
Hôpital FOCH
Chu Mondor
CH La Rochelle
CH Vendée
Chu E. Herriot
CHU Dijon
CHU Lapeyronie
CHU Angers
CH St Joseph St Luc
CH
CHU Guadeloupe
LYON Sud
CHU La Pitié Salpétrière
CHU Strasbourg
CHU La Source
Limoges University Hospital
Chu Tours
CHU Poitiers
University Hospital of Poitiers
CHU Lille
CHU marseille
Chu Cochin

region: Nouvelle-Aquitaine

nom_etablissement: CENTRE HOSP. UNIVERSITAIRE DE POITIERS

acronyme: FLORALI 2

titre: Comparaison d'une pré-oxygénation par ventilation non invasive avec une oxygénothérapie nasale à haut débit pour l'intubation des patients de réanimation en insuffisance respiratoire aiguë : étude prospective, randomisée, contrôlée.

nom_porteur: FRAT

prenom_porteur: Jean Pierre


acronym: VISMONEO

lead_sponsor: University Hospital, Lille

summary: Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with locally advanced BCC.

sponsor_collaborators:
University Hospital, Lille
Hoffmann-La Roche

location_facility:
CHU Ambroise Paré
Hôpital Saint-Louis
Hôpital Haut-Lévêque
Centre hospitalier Lyon Sud
Hôpital Pontchaillou
Hôpital Bichat
CH de Boulogne sur mer
Hôpital St André
Hôpital Saint Eloi
CHU de Besançon
Hôpital Robert Debré
Institut Gustave Roussy
Hôpital de la Timone
CHU - Hôpital d'Estaing
Clinique de Dermatologie
CHU Bocage
Hôpitaux de Brabois

title: Phase II Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)


title: A Multicenter Phase II Study of Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases

acronym: IPI+RTS

summary: This is a non-controlled, open label, Phase II Study of ipilimumab combined with a Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3 days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10 mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity or withdrawal of consent or disease progression. The primary objective is the overall survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker.

sponsor_collaborators:
University Hospital, Lille
Bristol-Myers Squibb

location_facility: Centre Régional de Lutte Contre le Cancer Eugène Marquis


title: Treatment of Chronic Subdural Hematoma by Corticosteroids

acronym: SUCRE

summary: Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural hematoma involves numerous inflammatory processes which could be inhibited by steroids.

ReferenceCitation: Henaux PL, Le Reste PJ, Laviolle B, Morandi X. Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):252. doi: 10.1186/s13063-017-1990-8.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Bordeaux Neurochirurgie A
CHU Nantes
HC Lyon
CHU Bordeaux Neurochirurgie B
CHU Tours
CHU Besançon
AP-HM - Hôpital La Timone
CHU Saint Etienne
CHU Poitiers
CHU Brest
CHU Caen
CHU Rouen
CHU Lille
CHU Strasbourg
CHU Nancy
CHU Angers
CHU Amiens

acronyme: SUCRE

titre: Traitement par corticoïdes des hématomes sous-duraux chroniques : une étude prospective randomisée

nom_porteur: MORANDI

prenom_porteur: Xavier


title: Analyse du caractère prédictif de l'échographie Ganglionnaire Pour le Diagnostic de bégninité ou malignité d'Une adénopathie Superficielle

acronym: EGAS

summary:
Investigators need to establish a formal diagnostic of superficial adenopathy through complementary investigations to find etiologic diagnostic ( Echography, adenogram).

Echography examination should be a guide to take in charge the adenopathy and to predict presence of malignant (primitive) or benin (reactional) character of adenopathy. The aim of this study is to codify the management of adenopathic patient with a diagnostic in 48 hours after examination. This fast diagnostic helps to prevent unnecessary biopsy, to avoid wasting time in case of a serious pathology.

lead_sponsor: University Hospital, Brest

location_facility:
Cabinet Lesconil
Cabinet Plouegat Guerrand
CHRU de Brest
Cabinet Lamneur
Cabinet Lanmeur
Cabinet Le Guilvinec
Cabinet Ergue Gaberit
Cabinet Quimper
Cabinet Brest
Caninet Brest Centre
Cabinet Penmarch
Cabine Le Guivinec
Cabinet Brest Centre
Cabinet Ergue Gaberic
CHIC Quimper


title: Validation de la Version française du Score de Fatigue " Brief Fatigue Inventory (BFI)

acronym: EAMG

summary:
Fatigue, or asthenia, is an important symptom for the diagnosis and follow-up of patients in routine as well as research oriented clinical practice.

Various questionnaires measuring fatigue have been developed, but few have been validated in french. MFI (Multidimensional Fatigue Inventory) has been validated in french in only one study. BFI (Brief Fatigue Inventory) has been translated but never validated in french language.

The main purpose of this study is to validate psychometrically the french version of BFI.

location_facility:
Cabinet Lesconil
Cabinet Plouegat Guerrand
Cabinet Lanmeur
Cabinet Lamneur
Cabinet Camaret/mer
Cabinet Le Guilvinec
Cabinet Quimper
Cabinet Rosporden
Cabinet Penmarch
Cabinet Brest Centre
Cabinet Ergue Gaberic


title: Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia

acronym: LABMI

summary: B-acute lymphoblastic leukaemia (ALL) is the most common childhood malignancy. Despite enhancement of childhood B-ALL outcome, relapses remain difficult to treat. Several studies in adult acute myeloid leukaemia have shown that proliferation of immunosuppressive cells -particularly T regulatory (Treg) cells and deficient natural killer (NK) cells- was associated with poor response to chemotherapy. However, few studies have been done on childhood ALL and none on relapse of B-ALL. Moreover, a newly described immunosuppressive B cells subset (Breg cells) seems to have a role in oncogenesis in mice model, but its significance has never been evaluated in human cancers. The purpose of this study is to prospectively evaluate the immune status of children newly diagnosed with first relapse of B-cell ALL, and to compare results with those of children treated for B-ALL in complete remission. Classic lymphocytic phenotype, proportions of immunosuppressive cells (Treg cells, deficient NK cells, Cytotoxic T-lymphocyte-associated protein 4 and/or Programmed T cell death 1) and thymopoiesis will be evaluated. The investigators assume that increase of immunosuppressive cells proportions could be associated with B-ALL relapse.

lead_sponsor: University Hospital, Angers

location_facility: University Hospital of Trousseau (Paris)

location_facility: University Hospital of Robert Debre (Paris)