title: Peri-operative Association of Immunotherapy (Pre-operative Association of Nivolumab and Ipilimumab, Post-operative Nivolumab Alone) in Localized Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR) Oeso-gastric Adenocarcinoma: An Open-label GERCOR Phase II Study

acronym: NEONIPIGA

summary: This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate the complete pathologic response rate (cPRR) with neoadjuvant nivolumab and ipilimumab combination in patients with MSI and/or dMMR localized oeso-gastric cancer.

ReferenceCitation: Andre T, Tougeron D, Piessen G, de la Fouchardiere C, Louvet C, Adenis A, Jary M, Tournigand C, Aparicio T, Desrame J, Lievre A, Garcia-Larnicol ML, Pudlarz T, Cohen R, Memmi S, Vernerey D, Henriques J, Lefevre JH, Svrcek M. Neoadjuvant Nivolumab Plus Ipilimumab and Adjuvant Nivolumab in Localized Deficient Mismatch Repair/Microsatellite Instability-High Gastric or Esophagogastric Junction Adenocarcinoma: The GERCOR NEONIPIGA Phase II Study. J Clin Oncol. 2023 Jan 10;41(2):255-265. doi: 10.1200/JCO.22.00686. Epub 2022 Aug 15.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
ICM Val d'Aurelle
CHU Nantes
Centre Léon Bérard
Hôpital Henri Mondor
CHRU Jean Minjoz
Hôpital Saint Antoine
Hôpital Européen Geroges Pompidou
Hôpital Saint Louis
CHU Toulouse
Institut Mutualiste Montsouris
CHRU Lille
CHU Poitiers
Institut Hospitalier Franco-Britannique
Hôpital Privé Jean Mermoz
CHU Pontchaillou Rennes


title: Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy

acronym: RIGHTCOLOCALCI

summary:
Anastomotic leakage is the major postoperative complication in right colectomy. Evaluation of calcification on coeliac trunk and mesenteric arteries on the preoperative CT scan could allow the identification of patient at-risk of postoperative complications.

A monocentric retrospective study performed at CHD Vendée concluded than a calcification score over or equal to 3 was associated with a higher risk of developping an anastomotic leakage.

The aim of this prospective multicentric study is to validate a calcification score based on preoperative CT scan analysis and focussing at coeliac trunk and mesenteric arteries.This study will involve patients operated on with a scheduled right colectomy.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Clinique Mutualiste de la Porte de l'Orient

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Assessment of the Diagnostic Approach to Specific Language Disorders and Learning Using a New Calibrated Tool: the Modular Battery Tests Computerized (BMTi)

acronym: ValidBMTI

summary:
The group of experts at HAS has defined the places of first and second-line workers in specific disorders of development and learning, as defined in the international diagnostic classifications International Classification of Diseases (CIM) CIM 11 and Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM 5. The referral to a second-level structure, a multidisciplinary structure in charge of carrying out the different cognitive assessments, requires a preliminary evaluation.

This orientation is based on a medical consultation, carried out by a doctor specialized in the field, with an exploration tool adapted to the different fields concerned.

The BMTi, a battery of third-generation tests (after the Rapid battery of evaluation of the cognitive functions (BREV) and then the Evaluation of cognitive functions and learning of the child (EDA)) will enable the doctor, from 2018, to carry out this orientation in a relevant way in response to children with a complaint about neurodevelopment and learning. .

The research project aims to validate this hypothesis, by comparing the diagnoses posed in a conventional way with the various multidisciplinary assessments, with the results of the transfer of all or part of the subtests of the BMTi by a doctor of second resort.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Intercommunal Creteil

collaborators: Association pour la recherche des troubles de l'apprentissage

collaborators: Association Française de Pédiatrie Ambulatoire- AFPA

collaborators: Association pour l'Etude du Développement de l'Enfant

location_country: Martinique France

location_facility:
Cabinet du Dr Reynaud
Cabinet du Dr Willig
Cabinet du Dr Pineau
Cabinet du Dr Gelbert
Cabinet du Dr Lubelski
Cabinet du Dr Cahn-Sellem
Centre Médical Pédiatrique Flammarion
Cabinet du Dr Werner
CH Versailles - André Mignot
Cabinet du Dr Kochert
CHU de Rouen
Centre Paris Santé Réussite
Cabinet du Dr Dulorme
Cabinet du Dr Piollet
Cabinet du Dr Vurpillat-Almanza
Hôpital Saint Eloi - Montpellier

intervention_type: Behavioral

status_simplified: Completed


title: Comparison of Trough Level-based Spacing and Clinical-based Spacing of Infliximab Infusions in Patients With Inflammatory Bowel Disease in Deep Remission; A Prospective, Multicenter, Open-label, Randomized, Controlled Study

acronym: SPACIFIX

summary: Comparison of trough level-based spacing and clinical-based spacing of infliximab infusions in patients with inflammatory bowel disease in deep remission A prospective, multicenter, open-label, randomized, controlled Study

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: University Hospital, Montpellier

location_facility:
Clermont-Ferrand University Hospital
CHRU Nancy - Hôpitaux de Brabois
Saint Etienne University Hospital
Nantes University Hospital
Toulouse University Hospital
Besançon University Hospital
Lille University Hospital
Pineton de Chambrun
Amiens University Hospital
Nîmes University Hospital
Caen University Hospital
APHP Beaujon Hospital
APHP Paris Cochin
Rennes University Hospital
Bordeaux University Hospital
Nice University Hospital

intervention_type: Other

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU MONTPELLIER

type_etablissement: CH

acronyme: SPACIFIX

titre: Comparaison de l'espacement des perfusions d'infliximab guidé par le dosage des taux résiduels d'infliximab à un espacement guidé par la clinique chez les patients atteints de maladies inflammatoires chroniques de l'intestin en rémission profonde Etude prospective, multicentrique, randomisée, controlée en ouvert

discipline_principale: gastro-entérologie

nom_porteur: Pineton De Chambrun

prenom_porteur: Guillaume


title: Effects of a Serious Game Based Exercise Program on the Functional Autonomy in Older Adults Living in Nursing Homes : SERIOUS AUTONOMY

summary: Assessment of the effect of a 12 weeks serious game based exercises program on physical performance in older adults living in nursing homes, in comparison with a control group that benefits from a classical exercise training program including balance, muscle strengthening and walking exercises with the same duration.

primary_purpose: Prevention

location_facility: EHPAD Pierre Laroque CCAS de Montpellier

location_facility: EHPAD Françoise Gauffier CCAS de Montpellier

location_facility: EHPAD Résidence La Camargue, Nimes (Groue Orpéa)

location_facility: EHPAD Résidence Château Notre Dame (Groupe Orpéa)


title: Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy

acronym: TEMPOS

summary:
The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, medico-economic study comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective of this health economics study is to perform a cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as primary criterion, expressed in cost per quality adjusted life year (QALY) gained. Cost-effectiveness analyses are performed as secondary objective with Incremental Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost per Life Year Gained. A long term evaluation is also performed, including a cost-utility, cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the erectile dysfunction up to 5 years after treatment, an evaluation of acute and late genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5 years after treatment.

Eight patients/year/center are expected to be recruited in 2 years in about twenty participating centers.

In total, to our knowledge, this study will be the first health economic evaluation which compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and complementary information to decision makers in order (i) to recommend the best strategy to adopt; (ii) to estimate the budget impact on the French National Health Insurance of the generalization of the cost-effective strategy. Finally, this study will allow to assess and compare accurately the erectile dysfunction after both treatment modalities.

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Center Eugene Marquis

location_facility: Institut régional du Cancer de Montpellier

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

location_facility: Institut de Cancérologie Lucien Neuwirth

intervention_type: Radiation

lead_sponsor_type: industriel

appel_a_projets: PRMEK

region: Bretagne

nom_etablissement: C.R.L.C.C. EUGENE MARQUIS

type_etablissement: CLCC

acronyme: TEMPOS

titre: TEMPOS : Trouble de l'Erection dans les cancers de Prostate de bon pronostic: étude Médico-économique de phase III comparant la curiethérapie à la radiOthérapie Stéréotaxique

discipline_principale: stereotactic body radiotherapy, brachytherapy

nom_porteur: DE CREVOISIER

prenom_porteur: Renaud


title: Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke

acronym: ETIS

summary: Study like register with biomarkers samples for patient experiencing acute ischemic stroke, to assess clinical outcomes and different factors that may affect the clinical outcomes.

time_perspective: Other

ReferenceType: derived

ReferenceCitation: Douarinou M, Gory B, Consoli A, Lapergue B, Kyheng M, Labreuche J, Anadani M, Blanc R, Marnat G, Bourcier R, Sibon I, Eugene F, Vannier S, Audibert G, Mione G, Richard S; ETIS Investigators. Impact of Strategy on Clinical Outcome in Large Vessel Occlusion Stroke Successfully Reperfused: ETIS Registry Results. Stroke. 2022 Jan;53(1):e1-e4. doi: 10.1161/STROKEAHA.121.034422. Epub 2021 Nov 3.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

version: submittedVersion

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

repositories_concat: HAL

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Happi Ngankou E, Gory B, Marnat G, Richard S, Bourcier R, Sibon I, Dargazanli C, Arquizan C, Maier B, Blanc R, Lapergue B, Consoli A, Vannier S, Spelle L, Denier C, Boulanger M, Gauberti M, Saleme S, Macian F, Clarencon F, Rosso C, Naggara O, Turc G, Ozkul-Wermester O, Papagiannaki C, Viguier A, Cognard C, Lebras A, Evain S, Wolff V, Pop R, Timsit S, Gentric JC, Bourdain F, Veunac L, Eugene F, Finitsis S; ETIS Registry Investigatorsdagger. Thrombectomy Complications in Large Vessel Occlusions: Incidence, Predictors, and Clinical Impact in the ETIS Registry. Stroke. 2021 Dec;52(12):e764-e768. doi: 10.1161/STROKEAHA.121.034865. Epub 2021 Oct 28.

oa_host_type: publisher

repositories_concat: closed

ReferenceCitation: Aubertin M, Weisenburger-Lile D, Gory B, Richard S, Blanc R, Ducroux C, Piotin M, Labreuche J, Lucas L, Dargazanli C, Benali A, Bourcier R, Detraz L, Vannier S, Guillen M, Eugene F, Walker G, Lun R, Guenego A, Consoli A, Marnat G, Maier B, Lapergue B, Fahed R; ETIS Investigators*. First-Pass Effect in Basilar Artery Occlusions: Insights From the Endovascular Treatment of Ischemic Stroke Registry. Stroke. 2021 Dec;52(12):3777-3785. doi: 10.1161/STROKEAHA.120.030237. Epub 2021 Aug 26.

ReferenceCitation: Ducroux C, Renaud N, Bourcier R, Marnat G, Sibon I, Gory B, Richard S, Dargazanli C, Arquizan C, Eugene F, Vannier S, Labreuche J, Walker G, Blanc R, Obadia M, Consoli A, Lapergue B, Fahed R; ETIS investigators. Embolus Retriever with Interlinked Cages (ERIC) versus conventional stent retrievers for thrombectomy: a propensity score-based analysis. J Neurointerv Surg. 2021 Mar;13(3):255-260. doi: 10.1136/neurintsurg-2020-016289. Epub 2020 Jun 30.

oa_host_type: closed

publisher_dissemination: British Medical Journal

ReferenceCitation: Boisseau W, Fahed R, Lapergue B, Desilles JP, Zuber K, Khoury N, Garcia J, Maier B, Redjem H, Ciccio G, Smajda S, Escalard S, Taylor G, Mazighi M, Michel P, Gory B, Blanc R; ETIS Investigators. Predictors of Parenchymal Hematoma After Mechanical Thrombectomy: A Multicenter Study. Stroke. 2019 Sep;50(9):2364-2370. doi: 10.1161/STROKEAHA.118.024512. Epub 2019 Jul 22.

lead_sponsor: Hopital Foch

location_facility:
CHU Dupuytren
CHU Nantes
Hôpital le Kremlin-Bicètre - APHP
CHU de Caen
CHU Montpellier
Hôpital Pitié Salpétrière
Chu Rouen
Hôpital Foch
CHU Toulouse
CH Bretagne Atlantique
CHU Rennes
Hôpital SAINTE ANNE
CHU Bordeaux
CHU Lyon
Fondation Ophtalmique de Rotschild
CHU Nancy


intervention_type: Drug

lead_sponsor: UNICANCER

summary:
It is a phase II trial, randomized, parallel, double blind, multicenter, comparing riluzole versus placebo.

The trial population is composed of patients ≥18 years old that have developed stage II/III colorectal cancer and are eligible for Simplified FOLFOX4 (6-12 cycles) adjuvant chemotherapy.

The primary objective is to assess the preventive efficacy of riluzole on the severity of oxaliplatin-induced peripheral neuropathy during the Simplified FOLFOX4 adjuvant chemotherapy of stage II/III colorectal cancers.

ReferenceCitation: Kerckhove N, Busserolles J, Stanbury T, Pereira B, Plence V, Bonnetain F, Krakowski I, Eschalier A, Pezet D, Balayssac D. Effectiveness assessment of riluzole in the prevention of oxaliplatin-induced peripheral neuropathy: RILUZOX-01: protocol of a randomised, parallel, controlled, double-blind and multicentre study by the UNICANCER-AFSOS Supportive Care intergroup. BMJ Open. 2019 Jun 9;9(6):e027770. doi: 10.1136/bmjopen-2018-027770.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

location_facility:
ICO - Site René Gauducheau
CHU de Saint-Etienne
CHU de Clermont -Ferrand
Clinique St Côme
Hia Percy
CHU de Reims
CHU de Dijon
Institut Jean Godinot
GHPSO
Centre Georges François Leclerc
Hôpital Foch
CH Beauvais
CH Annecy-Genevois
Hia Begin
ICO - Site Paul Papin
Centre François Baclesse

status: Active, not recruiting

title: Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy: A Phase II Randomized Study by UNICANCER With the Cooperation of AFSOS

type: EudraCT Number

source: euctr

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

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

titre: RILUZOX-01. Évaluation de l'efficacité du riluzole dans la prévention des neuropathies périphériques induites par l'oxaliplatine : Essai randomisé de phase II de l'intergroupe UNICANCER-AFSOS Soins de Support.

discipline_principale: cancer

nom_porteur: PEZET

prenom_porteur: Denis


title: Multifaceted Intervention for Increasing Performance of Cardiopulmonary Resuscitation by Laypersons in Out-of-hospital Cardiac Arrest. A Stepped Wedge Cluster Randomized Controlled Trial

acronym: DISPATCH

summary:
Cardiac arrest (CA) early recognition is essential in order to rapidly activate emergency services and for bystanders to begin cardiopulmonary resuscitation (CPR).

As soon as a call is received, EMS dispatchers should try to identify CA. This may be difficult, in a context of stress and distress of the person calling. Yet, it is vital for bystanders to initiate CPR. Survival can be multiplied by 2 to 4 if the bystanders initiate a CPR before the arrival of the emergency medical services.

This work aim to assess a multifaceted intervention combining 3 elements to improve the initial phone recognition of CA and raise the number of patients benefiting from CPR before EMS arrival on scene.

The first element is a dispatcher training to the early phone recognition of CA. This training will be based on the concept of active teaching, favouring the interactive work of learners in particular by listening to real dispatch recordings. It will be completed by continuing education with a distance teaching platform including the systematic listening of recorded CA calls.

The second element is based on the deployment of a software aiming to notify CA thanks to mobile phones. This system interfaced to a control software enables to request the participation of CPR-trained volunteers automatically. The volunteers have to be located in the patient's surroundings. The deployment of this mobile application will rely on first-aid volunteers, health personal and any trained volunteers willing to participate. A randomized control study in one city area proved the efficiency of a similar software to improve the proportion of CPR by bystanders.

The third element consists in a motivational feedback. A weekly overview of the management and the outcomes of patients who suffered CA will be broadcast to all the responders and volunteers in the mobile application.

ipd_sharing: Yes

ipd_sharing_description: Study protocol will be submitted for publication. IPD will be shared with other researcher.

lead_sponsor: University Hospital, Grenoble

location_facility: SAMU 73 - Centre Hospitalier Métropôle Savoie


title: Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma

summary:
The study aims to evaluate the prognostic value on the complete metabolic response rate (MCR), the incidence of relapse / progression, the Progression Free Survival (PFS) and the Overall Survival (OS).

at diagnosis
after the first cycle of CHOEP (early evaluation)
at the end of treatment

ReferenceType: background

ReferenceCitation: Sibon D, Fournier M, Briere J, Lamant L, Haioun C, Coiffier B, Bologna S, Morel P, Gabarre J, Hermine O, Sonet A, Gisselbrecht C, Delsol G, Gaulard P, Tilly H. Long-term outcome of adults with systemic anaplastic large-cell lymphoma treated within the Groupe d'Etude des Lymphomes de l'Adulte trials. J Clin Oncol. 2012 Nov 10;30(32):3939-46. doi: 10.1200/JCO.2012.42.2345. Epub 2012 Oct 8.

ReferenceCitation: Damm-Welk C, Mussolin L, Zimmermann M, Pillon M, Klapper W, Oschlies I, d'Amore ES, Reiter A, Woessmann W, Rosolen A. Early assessment of minimal residual disease identifies patients at very high relapse risk in NPM-ALK-positive anaplastic large-cell lymphoma. Blood. 2014 Jan 16;123(3):334-7. doi: 10.1182/blood-2013-09-526202. Epub 2013 Dec 2.

ReferenceCitation: Damm-Welk C, Pillon M, Woessmann W, Mussolin L. Prognostic factors in paediatric anaplastic large cell lymphoma: role of ALK. Front Biosci (Schol Ed). 2015 Jun 1;7(2):205-16. doi: 10.2741/S434.

ReferenceCitation: Lamant L, McCarthy K, d'Amore E, Klapper W, Nakagawa A, Fraga M, Maldyk J, Simonitsch-Klupp I, Oschlies I, Delsol G, Mauguen A, Brugieres L, Le Deley MC. Prognostic impact of morphologic and phenotypic features of childhood ALK-positive anaplastic large-cell lymphoma: results of the ALCL99 study. J Clin Oncol. 2011 Dec 10;29(35):4669-76. doi: 10.1200/JCO.2011.36.5411. Epub 2011 Nov 14.

lead_sponsor: The Lymphoma Academic Research Organisation

collaborators:
Hôpital Necker-Enfants Malades
Fondation ARC
Pfizer
Takeda

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: A Phase II Randomized Placebo-controlled Study to Assess the Impact on Outcome of Eltrombopag Administered to Elderly Patients With Acute Myeloid Leukemia Receiving Induction Chemotherapy

summary: Phase II randomized placebo-controlled study to assess the impact on outcome of Eltrombopag administered to elderly patients with Acute Myeloid Leukemia (AML) receiving induction chemotherapy. A phase II multicenter and randomized placebo-controlled study

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
Novartis Pharmaceuticals

location_facility: Institut Paoli-Calmettes - Hématologie 2

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

location_facility: Hôpital Saint-Eloi - Hématologie Clinique


type: Registry Identifier

title: Coffee Consumption and NASH in the French Population.

acronym: COCANASH

summary: The aim of our study is to evaluate the effect of coffee consumption on the risk of severe liver fibrosis in French patients with NASH.

lead_sponsor: Versailles Hospital

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial

acronym: APACaPOp

summary:
Exercise during chemotherapy (CT) is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). Exercise may also have beneficial effects on tumor outcome by decreasing insulin resistance, inflammation, and by modulating various pro-tumoral signalling pathways. It has been shown to reduce mortality in breast and colorectal cancer adjuvant setting.

This study aims to explore the effects of adapted physical activity (APA) in patients with resected pancreatic ductal adenocarcinoma (PDAC).

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital Henri Mondor
Hôpital Cochin
CHU de Reims
Institut Mutualiste Montsouris
CHU de Toulouse
Hôpital privé Jean Mermoz
CHU de Brest
Hôpital Edouard Herriot
CHU de Besançon
Hôpital Beaujon
Institut Curie
Centre Paul Strauss
Hôpital Haut-Lévêque
CHU de Rouen
CHR d'Orléans


title: RObotic PArtial Nephrectomy National Study (RoPaN Study)

acronym: ROPAN

summary: The purpose of the study is to set up the larger prospective study on robotic partial nephrectomy, to describe the characteristics of patients operated for kidney cancer by this surgical procedure and also to determine the modalities of hemostasis in this procedure.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU La Pitié Salpétrière/ Kremlin Bicêtre

intervention_type: Procedure


title: Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid

acronym: PRURIPB

summary:
Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact on quality of life have been little studied.

The objective of this study is to learn more about pruritus characteristics of patients with bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus, and then to better treat pruritus in this condition.

lead_sponsor: University Hospital, Brest

location_facility:
CH de Niort
CHRU de Brest
AP-HP, Hôpital Bichat
CHU de Saint-Etienne
CHU de Reims
CHU de Clermont-Ferrand
AP-HP, Hôpital Henri Mondor
CH Argenteuil
CHU Le Havre
CHU de Montpellier
AP-HP, Hôpital Cochin
CHU Caen
AP-HP, Hôpital Avicenne
CHU de Rouen
CHU de Bordeaux
HP-HM


title: Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

acronym: ShareD-BD

summary: The investigators hypothesize that implementation of a shared decision making care plan for prophylactic treatment will help therapeutic adherence of bipolar patients. They also anticipate that patients treated according to a shared decision making plan will have an elevated satisfaction of their care, quality of life and functionment, as well as a lower number of relapses

ReferenceCitation: Samalin L, Honciuc M, Boyer L, de Chazeron I, Blanc O, Abbar M, Llorca PM. Efficacy of shared decision-making on treatment adherence of patients with bipolar disorder: a cluster randomized trial (ShareD-BD). BMC Psychiatry. 2018 Apr 13;18(1):103. doi: 10.1186/s12888-018-1686-y.

license: cc-by

license_normalized: cc-by

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

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

publisher_dissemination: Springer-Nature

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal


title: Registry of Pregnancy Follow-up in Patients With Dilated Cardiomyopathy

summary:
Increasing cases of women with dilated cardiomyopathy with a project of pregnancy are observed. However there is few knowledge and publications about cardiac diseases in pregnant women. Moreover the majority of medical articles deal with women with congenital heart diseases, valvular pathologies or peripartum cardiomyopathies, and few data are available in literature about women with dilated cardiomyopathy diagnosed before or during the first months of the pregnancy.

Cardiologist and obstetrician advices are considerably limited when patients with dilated cardiomyopathy have a pregnancy project. Knowledges and know-how are currently based on limited personal experiment or on few clinical cases descriptions.

Pregnancy represents a high-risk situation for patients with dilated cardiomyopathy. Creation of a cohort of pregnant women with dilated cardiomyopathy collecting specific data will allow to have a better overview and to appreciate possibilities of a pregnancy project, evolution risks and modalities for medical attention and to improve follow-up and advices delivered to these patients.

lead_sponsor: Nantes University Hospital

location_facility:
Ap-Hp Bichat
Chu Angers
Chru Lille
CHU de NANTES
Chu Toulouse
Hegp Pompidou
Hospital Salpetrière
Chu Nancy
Chru de Brest
Hospital Henri Mondor
Hospital Lariboisière
Chu Rennes
AP-HM
Chu Rouen
CHU NICE


title: Prospective Study Assessing the Impact of RNA Genomic Profile Defined by a Genomic Test on Treatment Decision-making in Breast Cancer Patients With an ISH Equivocal HER2 Status- EQUIVOK Study

acronym: EQUIVOK

summary:
The American Society of Clinical Oncology (ASCO) and the /College of American Pathologists (CAP) recommend that HER2 status (negative or positive) must be determined in all patients with invasive breast cancer. The knowledge of HER2 status will help the oncologist in prescribing or not a HER2-targeted therapy to patients. Presently, two main methods are used to assess HER2 status: immunohistochemistry (IHC, protein expression) and in situ hybridization (ISH, gene expression) in order to classify tumor sample as positive, negative or equivocal. When a tumor is classified HER 2+ by IHC method, a second test is performed using ISH methods (FISH, SISH, CISH). In case of HER2 equivocal result with ISH method (4 ≤HER2 gene number copy <6), the patient is eligible to an anti-HER2 therapy after discussed during MD-MM. This decision should be individualized on the basis of patient status (comorbidities and prognosis) and patient preferences after discussing available clinical evidence.

Based on molecular classification, RNA expression could help to discriminate breast cancer subtypes (luminal A, luminal B, HER2-overexpressed and triple negative). Prosigna is a genomic test, developed by NanoString® based on the PAM50 gene signature, which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the HER2 status.

This study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population. In addition, concordance tests will be performed. The aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in HER2 equivocal patients using genomic testing.

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: Centre Jean Perrin

sponsor_collaborators:
Centre Jean Perrin
Roche Pharma AG
NanoString Technologies, Inc.

location_facility:
Institut de Cancérologie de Lorraine
Centre Léon Bérard
Institut Bergonie
CHRU Jean Minoz
Institut Jean Godinot
Institut Claudius Regaud
Institut de Cancérologie de Montpellier
Centre François Baclesse
Institut du Cancer COURLANCY
CHU Albert Michalon
Institut de Cancérologie de l'Ouest
Hopital DUPUYTREN
Centre Paul Strauss
Centre Georges François Leclerc
Institut Paoli Calmettes
Centre Jean Perrin

intervention_type: Diagnostic Test

status_simplified: Unknown


title: Study Evaluating the Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program, for Metastatic Cancer Patients Receiving Oral Targeted Therapy: The UNICANCER SdS 01 QUALIOR Study

acronym: QUALIOR

summary: This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) <3/10), and life expectancy ≥3 months.

primary_purpose: Supportive Care

ReferenceCitation: Joly F, Lefeuvre-Plesse C, Garnier-Tixidre C, Helissey C, Menneveau N, Zannetti A, Salas S, Houede N, Abadie-Lacourtoisie S, Stefani L, Nenan S, Rieger I, Durand-Zaleski I, Descotes JM, Anota A. Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial. BMC Cancer. 2020 Oct 9;20(1):975. doi: 10.1186/s12885-020-07381-4.

repositories_concat: PubMed Central

sponsor_collaborators:
UNICANCER
CAMI: Sport & Cancer

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel

location_facility: INSTITUT CURIE - Site René Huguenin St Cloud

location_facility: CH Nimes - Institut de Cancérologie du Gard


title: A Multicentric, Prospective Cohort Study Aiming to Evaluate the Added Value of a Large Molecular Profiling Panel (Panel FoundationOne) Versus a Limited Molecular Profiling Panel (Panel CONTROL) in Advanced Solid Tumors.

acronym: PROFILER 02

summary:
The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to compare the clinical relevance of a large Next-generation sequencing (NGS) panel (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients with advanced solid tumors.

This study will allow adapting the therapeutic management of these patients, if needed, by giving them recommended therapies (commercialized or in ongoing clinical trials), based on the recommendations of the Molecular Tumor Board (MTB).

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
Roche Pharma AG

location_facility: Institut de Cancérologie Lucien NEUWIRTH

intervention_type: Genetic


title: Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications

summary: The aim of this interventional study is to optimize the movements and discipline of surgical staff in order to improve the quality of care, the safety of the patient in the surgery and to prevent the postoperative complications in the broad sense and in particular the infection of the surgical site. The intervention will be carried out using tools of new technologies allowing the monitoring of the movements and the sound level associated with techniques of behavior change inspired by those used in the human and social sciences.

ReferenceCitation: Birgand G, Haudebourg T, Grammatico-Guillon L, Ferrand L, Moret L, Gouin F, Mauduit N, Leux C, Le Manach Y, Lepelletier D, Tavernier E, Lucet JC, Giraudeau B. Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO2): study protocol for a cluster randomised trial. Trials. 2019 May 20;20(1):275. doi: 10.1186/s13063-019-3370-z.

repository_institution: Imperial College London - Spiral

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

repositories:
HAL
PubMed Central
spiral.imperial.ac.uk

location_facility:
Saint Grégoire private hospital
Nantes University Hospital
Le Mans Hospital
Tours University Hospital
Pré surgical clinic
Sante Atlantique
Angers University Hospital
Hôpital Lariboisière
IMM
Saint-Léonard Clinic
Vendée Hospital
Hôpital Beaujon
H.P. Confluent
Rennes University Hospital
Saint-Nazaire Hospital
Vannes Hospital

appel_a_projets: PREPS

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

titre: Amélioration des comportements peropératoires des personnels pour prévenir les complications post-opératoires

discipline_principale: organisation des soins

nom_porteur: BIRGAND

prenom_porteur: Gabriel


acronym: ATALK

lead_sponsor: Hoffmann-La Roche

summary: This study will evaluate the efficacy and safety of alectinib, in selected participants, with anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC), after disease progression on prior treatment strategy with crizotinib, as only ALK inhibitor, and eventually chemotherapy treatment(s).

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: CHRU Lille Service de Pneumologie et Oncologie Thoracique

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Hopital Augustin Morvan; Oncologie Thoracique

title: An Open-Label, Multicenter, Single-Arm, Phase II Study to Assess the Efficacy and Safety of Alectinib in Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on Prior ALK Inhibitor Therapy


title: Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study

summary: This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.

status: Unknown status

ReferenceCitation: Such P, Bog M, Kabra MS, Jorgensen KT, de Jong-Laird AC. A Noninterventional Cohort Study Assessing Time to All-Cause Treatment Discontinuation After Initiation of Aripiprazole Once Monthly or Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-Onset Schizophrenia. Prim Care Companion CNS Disord. 2021 Sep 30;23(5):20m02886. doi: 10.4088/PCC.20m02886.

publisher_dissemination: Physicians Postgraduate Press, Inc

lead_sponsor: Otsuka Pharmaceutical Europe Ltd

sponsor_collaborators:
Otsuka Pharmaceutical Europe Ltd
H. Lundbeck A/S

location_country: Germany Italy Spain France

location_facility: Centre Hospitalier Gillaume regnier-CHGR

location_facility: Mental Health Department (MDSM) ASP di Messina

location_facility: Dipartimento di Salute Mentale- ASL Napoli

location_facility: Ospedale Madonna del Soccorso San Bendedetto del Tronto

location_facility: Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria

location_facility: Dipartimento di Salute Mentale -ASL Modena

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Cura Neuropsichiatria Villa Von Siebenthal

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Hospital Clínico Universitario de Valencia

location_facility: IINA (Instituto Internacional de Neurociencias Aplicadas)

location_facility: Unit Mental Health District Nº72- ASL Salerno

location_facility: Unita Operativa- Salute Mentale di Salerno

location_facility: P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura

location_facility: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari


title: Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study

acronym: TERIS

summary:
Multiple sclerosis (MS) is a common cause of severe neurological disability in young adults, resulting from an autoimmune interruption of both myelin and axons within the central nervous system (CNS). The diagnosis is made by fulfilling both spatial criteria, by meeting the requisite number of lesions within the brain or spinal cord, along with criteria for time, by demonstrating a history of at least a second clinical attack or the development of a new MS lesion on MRI after the seminal neurological event. In the case of MS, healthy individuals who do not exhibit signs of neurological dysfunction commonly have brain MRI studies performed for a reason other than an evaluation for MS that reveal unexpected anomalies highly suggestive of demyelinating plaques given their size, location, and morphology. These healthy subjects lack symptomatology suggestive of MS and fulfill formal criteria for radiologically isolated syndrome (RIS), a recently described MS subtype that expands upon the phenotype of at-risk individuals for future demyelinating events. The discovery of such anomalies creates intersecting neuro-ethical, legal, social, and practical medical management quandaries and is, therefore, of both immediate and long-term clinical significance. Despite advancements in the characterization of RIS subjects, and in our understanding of risk factors for initial symptom development, the effect of treatment on such cases remain unclear.

The purpose of this investigation is to systematically study the efficacy of Teriflunomide in those individuals who possess incidental white matter anomalies within the brain and following a MRI study that is performed for a reason other than for the evaluation of MS.

RIS subjects are frequently exposed to disease modifying therapies despite the lack of scientific literature supporting the use of such treatments. Earlier treatment intervention may extend the time to the first acute or progressive clinical event resulting from CNS demyelination and reduce radiological progression. In addition, early treatment may result in more profound effects on reducing disability progression long-term.

The primary outcome measure for this trial is the time to the first acute or progressive neurological event resulting from CNS demyelination.

This study will include RIS subjects from the Europe who fulfill 2009 RIS Criteria.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Turkey Switzerland France

location_facility: Ondokuz Mayis University, Faculty of Medicine


title: Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)

summary:
The trial will enroll 194 previously untreated DLBCL patients over 20 months, with the objective to send to the local investigator an extensive molecular tumor characterization by D38 in at least 80% of enrolled patients.

The feasibility and efficiency will be demonstrated by deploying and operating a nation-wide network of dedicated multidisciplinary platforms.

sponsor_collaborators: The Lymphoma Academic Research Organisation

location_facility: CHU de Poitiers - Hôpital de la Miletrie


title: Bronchoalveolar Lavages in the Intensive Care Unit : Indications, Adverse Respiratory Effects, Contribution to Diagnosis and Therapy. A Multicenter, Prospective, Observational Study

acronym: REA-LBA

summary:
Little is known about bronchoalveolar lavages performed for cytological assessment during bronchial fibroscopy in critically ill patients. Frequency of use, indications, actual contribution to diagnosis and therapeutic decision, and complications have not been extensively assessed.

The primary objective of this multi center, prospective, observational study is to describe the frequency of use of bronchoalveolar lavages for cytological assessement in critically ill patients, identify their indications, assess their contribution to diagnosis and therapeutic decisions, and estimate the frequency of induced respiratory events.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHD de VENDEE
Hôpital RAYMOND POINCARE
CHU de STRASBOURG
CHU de STRASBOURG NHC
CHR d'ORLEANS
CH d'ANGOULEME
CHU de DIJON
CH de LA ROCHELLE
CH de MONTAUBAN
CHRU de NANTES
Hôpital Nord de Marseille
CHU d'ANGERS
CHRU de POITIERS
CHRU de TOURS
Hopital de La Timone
CH Victor DUPOUY


title: Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.

acronym: Restorelle

summary: Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. According to detailed medical history and a thorough physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated for transvaginal anterior and posterior surgical repair either as mechanical support or as reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are known but only limited data have been reported on the use of Restorelle® in the treatment of pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of Restorelle® Direct Fix in pelvic organ prolapse repair.

time_perspective: Retrospective

ReferenceCitation: Le Normand L, Cosson M, Cour F, Deffieux X, Donon L, Ferry P, Fatton B, Hermieu JF, Marret H, Meurette G, Cortesse A, Wagner L, Fritel X. [Clinical practice guidelines: Summary of recommendations for first surgical treatment of female pelvic organ prolapse by 5 French academic societies: AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP]. Prog Urol. 2016 Jul;26 Suppl 1:S1-7. doi: 10.1016/S1166-7087(16)30424-9. French.

ReferenceCitation: Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5.

ReferenceCitation: Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.

ReferenceCitation: Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.

ReferenceCitation: Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification System (POP-Q) - a new era in pelvic prolapse staging. J Med Life. 2011 Jan-Mar;4(1):75-81. Epub 2011 Feb 25.

ReferenceCitation: Lousquy R, Costa P, Delmas V, Haab F. [Update on the epidemiology of genital prolapse]. Prog Urol. 2009 Dec;19(13):907-15. doi: 10.1016/j.purol.2009.09.011. Epub 2009 Nov 4. French.

ReferenceCitation: Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016 Feb 9;2(2):CD012079. doi: 10.1002/14651858.CD012079.

ReferenceType: result

ReferenceCitation: Ferry P, Bertherat P, Gauthier A, Villet R, Del Piano F, Hamid D, Fernandez H, Broux PL, Salet-Lizee D, Vincens E, Ntshaykolo P, Debodinance P, Pocholle P, Thirouard Y, de Tayrac R. Transvaginal treatment of anterior and apical genital prolapses using an Ultra lightweight mesh: Restorelle(R) Direct Fix. A retrospective study on feasibility and morbidity. J Gynecol Obstet Hum Reprod. 2018 Nov;47(9):443-449. doi: 10.1016/j.jogoh.2018.06.001. Epub 2018 Jun 18.

publisher_dissemination: Elsevier

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)

summary: This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks

ReferenceCitation: Gantner P, Hessamfar M, Souala MF, Valin N, Simon A, Ajana F, Bouvet E, Rouveix E, Cotte L, Bani-Sadr F, Hustache-Mathieu L, Lebrette MG, Truchetet F, Galempoix JM, Piroth L, Pellissier G, Muret P, Rey D; E/C/F/TAF PEP Study Group. Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis. Clin Infect Dis. 2020 Feb 14;70(5):943-946. doi: 10.1093/cid/ciz577.

publisher_dissemination: Oxford University Press

lead_sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

location_facility:
CHU Ambroise Paré
Hôpital Jean Minjoz
Hôpital Tenon
Hôpitaux Universitaires
CHU de Reims
Hôpital Manchester
CHU
Hôpital Foch
CHU Bichat
CHR de Metz
CHU Dijon
Hôpital de Tourcoing
Hôpital Saint-André
Hôpital Croix Rousse
GH Pitié Salpetriere
Hôpital Saint-Antoine


title: A Phase 2 BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer

acronym: BIONIKK

summary:
Disease and Stage: naïve metastatic kidney cancer.

A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer

ReferenceCitation: Vano YA, Elaidi R, Bennamoun M, Chevreau C, Borchiellini D, Pannier D, Maillet D, Gross-Goupil M, Tournigand C, Laguerre B, Barthelemy P, Coquan E, Gravis G, Houede N, Cancel M, Huillard O, Beuzeboc P, Fournier L, Mejean A, Cathelineau X, Doumerc N, Paparel P, Bernhard JC, de la Taille A, Bensalah K, Tricard T, Waeckel T, Pignot G, Braychenko E, Caruso S, Sun CM, Verkarre V, Lacroix G, Moreira M, Meylan M, Bougouin A, Phan L, Thibault-Carpentier C, Zucman-Rossi J, Fridman WH, Sautes-Fridman C, Oudard S. Nivolumab, nivolumab-ipilimumab, and VEGFR-tyrosine kinase inhibitors as first-line treatment for metastatic clear-cell renal cell carcinoma (BIONIKK): a biomarker-driven, open-label, non-comparative, randomised, phase 2 trial. Lancet Oncol. 2022 May;23(5):612-624. doi: 10.1016/S1470-2045(22)00128-0. Epub 2022 Apr 4.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

repositories: HAL univOAK

repositories_concat: HAL;univOAK

ReferenceCitation: Epaillard N, Simonaggio A, Elaidi R, Azzouz F, Braychenko E, Thibault C, Sun CM, Moreira M, Oudard S, Vano YA. BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naive metastatic kidney cancer. Bull Cancer. 2020 Jun;107(5S):eS22-eS27. doi: 10.1016/S0007-4551(20)30283-6.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Institut de Cancérologie du Gard - CHU Caremeau

location_facility: Centre Hospitalier Lyon Sud - Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL)


title: Six Years of Follow-up After Extended Duration of Oral Anticoagulant Therapy for a First Episode of Idiopathic Pulmonary Embolism or Proximal Deep Vein Thrombosis.

acronym: Padis-Ext

summary: Beyond the first 6 months of anticoagulation, patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after stopping anticoagulations. Extending anticoagulant therapy for an additional 18 months is associated with a major reduction of recurrent VTE; however this benefit tended to be lost after stopping anticoagulation during a follow-up period of two years. This risk of recurrentce is likely to continuously increase over the years as well as the risk of chronic thromboembolic pulmonary hypertension (after pulmonary embolism) or the risk of post-thrombotic syndrome (after deep vein thrombosis). The aim of the PADIS-EXTENSION trial is to estimate these risks over 6 years of follow-up in patients who have been initially treated during 6 months or 24 months (patients included in the PADIS PE and PADIS DVT trial).

location_facility:
Hôpital Européen Georges Pompidou
Hotel Dieu
CHRU de Brest
CHU de St Etienne
CH St Brieuc
CHU de Clermont-Ferrand
AP-HP Kremlin Bicetre
CHU de Toulouse
CHU de Tours
CHU de Nantes
CHU de Grenoble
CHU de Rennes
CH de Lannion
CH de Lorient
CHIC Quimper


title: Biological and Clinical Database for Pancreatic Adenocarcinoma

acronym: BACAP

summary:
BACAP is a biobank dedicated to the pancreatic adenocarcinoma funded by institut national institue du cancer (INCa) and coordinated by Dr Barbara Bournet from Toulouse hospital. This base includes clinical data and biological samples such as blood, serum, plasma, saliva, DNA and RNA from tumors cells.

The mission of this prospective project is to make available to the scientific community a clinical biological base from patients with pancreatic adenocarcinoma

ReferenceCitation: Maulat C, Canivet C, Touraine C, Gourgou S, Napoleon B, Palazzo L, Flori N, Piessen G, Guibert P, Truant S, Assenat E, Buscail L, Bournet B, Muscari F, The Bacap Consortium. A New Score to Predict the Resectability of Pancreatic Adenocarcinoma: The BACAP Score. Cancers (Basel). 2020 Mar 25;12(4):783. doi: 10.3390/cancers12040783.

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

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

publisher_dissemination: MDPI

ReferenceCitation: Frere C, Bournet B, Gourgou S, Fraisse J, Canivet C, Connors JM, Buscail L, Farge D; BACAP Consortium. Incidence of Venous Thromboembolism in Patients With Newly Diagnosed Pancreatic Cancer and Factors Associated With Outcomes. Gastroenterology. 2020 Apr;158(5):1346-1358.e4. doi: 10.1053/j.gastro.2019.12.009. Epub 2019 Dec 14.

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

ReferenceCitation: Canivet C, Gourgou-Bourgade S, Napoleon B, Palazzo L, Flori N, Guibert P, Piessen G, Farges-Bancel D, Seitz JF, Assenat E, Vendrely V, Truant S, Vanbiervliet G, Berthelemy P, Garcia S, Gomez-Brouchet A, Buscail L, Bournet B; BACAP Consortium. A prospective clinical and biological database for pancreatic adenocarcinoma: the BACAP cohort. BMC Cancer. 2018 Oct 16;18(1):986. doi: 10.1186/s12885-018-4906-4.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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

location_facility: Institut Regional du Cancer de Montpellier


title: DIFFICULT PERIPHERAL INTRAVENOUS ACCESS IN ADULT DURING THE PREOPERATIVE PERIOD

acronym: VENSCORE

summary:
The objective of the prospective multicenter observational study consists in defining a difficult intravenous access score in adult, during the preoperative period.

The main objective: the outcome of interest is defined as failure of cannulation on first attempt.

The risk factors of failure of cannulation on first attempt will be described. Adjusted multivariate models will be constructed. A prediction model will be proposed according to the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD)

location_facility: Hôpital d'instruction des Armées Robert Picqué

location_facility: Centre hospitalier Universitaire de Bordeaux


acronym: REGOLD

lead_sponsor: Federation Francophone de Cancerologie Digestive

summary: Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer

ReferenceCitation: Aparicio T, Darut-Jouve A, Khemissa Akouz F, Monterymard C, Artru P, Cany L, Romano O, Valenza B, Le Foll C, Delbaldo C, Falandry C, Norguet Monnereau E, Ben Abdelghani M, Smith D, Rinaldi Y, Pere Verge D, Baize N, Maillard E, Dohan A, Des Guetz G, Pamoukdjian F, Lepage C. Single-arm phase II trial to evaluate efficacy and tolerance of regorafenib monotherapy in patients over 70 with previously treated metastatic colorectal adenocarcinoma FFCD 1404 - REGOLD. J Geriatr Oncol. 2020 Nov;11(8):1255-1262. doi: 10.1016/j.jgo.2020.04.001. Epub 2020 Apr 22.

evidence: open (via crossref license)

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

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

location_facility: Caluire et Cuire - Infirmerie Protestante de Lyon

title: Phase II Study Evaluating the Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years Old With a Metastatic Colorectal Adenocarcinoma .


title: Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study.

acronym: CASTA-DIVA

summary: The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events.

ReferenceCitation: Planquette B, Bertoletti L, Charles-Nelson A, Laporte S, Grange C, Mahe I, Pernod G, Elias A, Couturaud F, Falvo N, Sevestre MA, Ray V, Burnod A, Brebion N, Roy PM, Timar-David M, Aquilanti S, Constans J, Bura-Riviere A, Brisot D, Chatellier G, Sanchez O, Meyer G, Girard P, Mismetti P; CASTA DIVA Trial Investigators. Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism: A Randomized Trial. Chest. 2022 Mar;161(3):781-790. doi: 10.1016/j.chest.2021.09.037. Epub 2021 Oct 8.

ReferenceCitation: Riaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Bayer

location_facility: Centre hospitalier Lyon Sud - Medecine interne (011)

location_facility: Hopital Saint Andre - Medecine vasculaire (015)

location_facility: CHU Saint Etienne - Medecin vasculaire et therapeutique (006)

location_facility: Institut Curie - Soins de support en Cancerologie (020)

location_facility: HEGP - Pneumologie et soins intensifs (001)

location_facility: Hopital Saine Musse - Service de Medecine Vasculaire (010)

location_facility: CHU Brest - Departement de medecin interne et pneumologie (008)

location_facility: CHU Le Bocage - Medecine interne 1 (014)

location_facility: CHU Grenoble - Medecine vasculaire (007)


acronym: BISPHOO

intervention_type: Device

summary: Osteoid osteoma (OO) is a benign osteogenic tumor occurring in children and young adults, responsible for intense bone pain, which has a tendency to spontaneously heal with mineralization of the nidus, but extremely slowly. This healing may be accelerated in patients taking NSAIDs regularly during a few years. The long delay for healing and intense pain, explain why patients are quickly directed to surgeons or specialized radiology departments for tumor ablation. But percutaneous treatment or surgical excision destruction can expose the patient to a substantial risk in terms of neurologic or joint damages, depending on the location. Bisphosphonates treatment may be an effective alternative to percutaneous treatment by accelerating the natural history of OO.

location_facility: Hôpital LARIBOSISIERE - Service radiologie ostéo-articulaire

location_facility: Hôpital ROGER SALENGRO - Service d'Orthopédie A

location_facility: Hôpital LAPEYRONIE - Service Rhumatologie

location_facility: Hôpital ROGER SALENGRO - Radiologie et imagerie musculo-squelettique

location_facility: Hopital PELLEGRIN - Service d'imagerie diagnostique et interventionnelle de l'adulte

location_facility: Hopital PELLEGRIN - Service rhumatologie

location_facility: Hôpital LARIBOSISIERE - Service rhumatologie

title: Non-inferiority Trial of Three Cycles of Zoledronic Acid Versus Percutaneous Thermal Ablation in Osteoid Osteoma

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: BISPHOO

titre: Traitement de l'ostéome ostéoïde : étude de non-infériorité de trois perfusions d'acide zolédronique par rapport à une destruction tumorale percutanée

discipline_principale: radiologie

nom_porteur: BOUSSON

prenom_porteur: Valérie


title: EVRIOS : Comparative Evaluation of Low Versus High Doses of Rifampicin in the Treatment of Staphylococcal Bone and Joint Infections

acronym: EVRIOS

summary:
Rifampicin is an antibiotic usually required to treat susceptible Staphylococcus spp. osteo-articular infections, most frequently in association with a fluoroquinolone when the strain is susceptible to both agents. It is the reference treatment for orthopedic infections with implanted material.

For tuberculosis treatment the dosage of 10 mg/kg/j is usually prescribed, while in the treatment of Staphylococcus spp. infections the highest dosage of 20 mg/kg/j is proposed by French experts' recommendations from 2009.

However, there is little evidence in the literature, which could set out arguments to choose the best dosage of rifampicin, which may vary from 5 to 20 mg/kg.

The issue with rifampicin is side effects, in particular with long-term treatment. Many side effects may occur in 10 to 20% of patients and sometimes leads to dosage reduction or treatment interruption.

In the literature, there is little evidence that higher rifampicin dosage is associated with higher frequency of adverse effects. Depending on the nature of the toxicity, one could say that hypersensitivity could be independent from dosage, when digestive disorders may be related. Plasmatic concentrations studies have not given strong arguments to link higher rifampicin dosages with side effects occurrence rates. After oral absorption, plasmatic peak occurs after two to five hours and varies among individuals but also in the same patient overtime. This particular pharmacokinetic profile could explain discrepancy in adverse events (AEs) frequencies.

lead_sponsor: Rennes University Hospital

location_facility:
Nantes university hospital
Brest university hospital
Pau hospital
Angers university hospital
Caen university hospital
Rennes university hospital
Tours university hospital
Poitiers university hospital
Vannes hospital
Lorient hospital
Bordeaux university hospital
Toulouse university hospital
La Roche sur Yon hospital
Saint-Brieuc hospital
Clinique du Parc et Hôpital Jean Mermoz
Saint-Malo hospital

nom_etablissement: CHRU RENNES

acronyme: EVRIOS

titre: EValuation comparative de faibles et fortes doses de Rifampicine dans le traitement des Infections Ostéo-articulaires à staphylocoques

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: ARVIEUX

prenom_porteur: Cédric


title: Economic Evaluation Comparing Standard Balloon Angioplasty Versus Drug-eluted Balloon or Laser-Excimer in Association With Drug-eluted Balloon in the Treatment of Femoropopliteal Artery In-stent Restenosis.

acronym: INTACT

summary: The aim of this multicenter triple-arm randomized study is to compare two innovative techniques with the gold standard currently used and providing unsatisfactory results for the In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol compares the use of drug-coated balloons (paclitaxel - antimitotic) used alone or in association with the Excimer Laser to recalibrate the vessel lumen into the stent by destroying the whole fibrous material to the standard angioplasty using plain balloons. INTACT study main objective is to assess cost-effectiveness ratio of the treatment of femoropopliteal artery in-stent restenosis by comparing these two innovative strategies and the standard one in terms of cost per Qaly (Quality adjusted life-years) gained at 18 months from a collective perspective.

primary_purpose: Health Services Research

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Hôpital Européen Georges Pompidou - AP-HP de Paris

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de St Etienne

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: University Hospital of Bordeaux - Hospital Pellegrin

appel_a_projets: PRME

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: INTACT

titre: Evaluation médico-économique du traitement des resténoses intra-stents périphériques comparant l'angioplastie avec ballons standards, ballons actifs seuls ou Laser-Excimer associé aux ballons actifs

discipline_principale: economie de la santé

nom_porteur: Ducasse

prenom_porteur: Eric


lead_sponsor: Centre Francois Baclesse

summary: ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.

ReferenceCitation: Joly F, Fabbro M, Follana P, Lequesne J, Medioni J, Lesoin A, Frenel JS, Abadie-Lacourtoisie S, Floquet A, Gladieff L, You B, Gavoille C, Kalbacher E, Briand M, Brachet PE, Giffard F, Weiswald LB, Just PA, Blanc-Fournier C, Leconte A, Clarisse B, Leary A, Poulain L. A phase II study of Navitoclax (ABT-263) as single agent in women heavily pretreated for recurrent epithelial ovarian cancer: The MONAVI - GINECO study. Gynecol Oncol. 2022 Apr;165(1):30-39. doi: 10.1016/j.ygyno.2022.01.021. Epub 2022 Feb 2.

sponsor_collaborators:
Centre Francois Baclesse
ARCAGY/ GINECO GROUP
French Cancer Research Hospital Program

location_facility: ICL Institut de Cancérologie de Lorraine

title: A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer


title: Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema

acronym: TRIOZ

summary:
Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only triamcinolone acetonide was available to ophthalmologists. This molecule, developed initially for rheumatological or dermatological use, has been increasingly deployed in ophthalmology, while still off-label.

In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into the vitreous cavity obtained the label for inflammatory macular edema. This protocol is therefore designed to compare the efficacy and safety of peri- and intra-ocular injections of corticosteroids in the treatment of inflammatory macular edema.

ReferenceCitation: Couret C, Poinas A, Volteau C, Riche VP, Le Lez ML, Errera MH, Creuzot-Garcher C, Baillif S, Kodjikian L, Ivan C, Le Jumeau de Kergaradec LM, Chiffoleau A, Jobert A, Jaulin J, Biron L, Hervouet E, Weber M. Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial. Trials. 2020 Feb 10;21(1):159. doi: 10.1186/s13063-020-4066-0.

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

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

acronyme: TRIOZ

titre: Comparaison de l'efficacité et de la tolérance d'une injection sous-conjonctivale de triamcinolone et d'un implant intravitréen de 700µg dexaméthasone sur l'dème maculaire inflammatoire

discipline_principale: ophtalmologie

nom_porteur: WEBER

prenom_porteur: Michel


title: Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy

acronym: NIGA-RA

summary:
The anti-hinge region antibodies would be a relevant biomarker of IgA nephropathy. Beyond a prognostic value (which could increase the risk of Renal Absolute), the longitudinal monitoring for these antibodies could be of interest: (1) in the monitoring of patients (in place including a possible repetition renal biopsy); (2) to guide treatment decisions and (3) in clinical research, as an outcome (in substitution for the occurrence of kidney failure) in therapeutic trials IgA nephropathy.

This research project constitutes the first step in validating these antibodies biomarker of IgA nephropathy and its main objective is to study the performance of the blood levels of anti-hinge region antibodies in the diagnosis of progressive forms of histologically IgA nephropathy as defined by the Renal Risk Absolute.

The secondary objectives of this project are to establish a bio-collection that will allow us to search for other prognostic factors (genetic, cellular and serum) of IgA nephropathy and to evaluate the performance of Renal Absolute risk by integrating Oxford score, the new international histological classification.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hôpital Edouard. HERRIOT
Hôpitaux Drome Nord
CH de CHAMBERY
CHU de GRENOBLE
CH d'ANNECY
CH de BOURG EN BRESSE
CHU de CLERMONT-FERRAND
CH du PUY EN VELAY
CHU de SAINT-ETIENNE
CHU de DIJON
CH d'ANNONAY
Centre Hospitalier de Lyon Sud
CH de ROANNE
CH de VALENCE
Clinique du TONKIN

intervention_type: Biological


acronym: PIRAT

summary:
IgA nephropathy (IgAN) is a histologically defined glomerulonephritis (renal biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at least 1+) by immunofluorescence. The clinic allows excluding secondary forms (10-15%). Recurrence of this condition on the renal graft is time-dependent and confirmed in 25 to 50% of 10 years post-transplant.

The primary immunosuppressive induction regimens currently used in kidney transplantation are the anti-lymphocyte globulin (GAL) whose main target is human T lymphocytes (ATG, polyclonal) and monoclonal anti-CD25 antibodies (α chain of the interleukin receptor 2 in the surface of T lymphocytes). Due to their potent and prolonged immunosuppressive properties, the ATG may prevent or delay the recurrence on renal transplant.

The aim of this study was to evaluate the influence of induction therapy (ATG versus Basiliximab) in the cumulative incidence at 5 years of (IgAN) recurrence after a first kidney transplant.

This is a prospective, multicenter, randomized, open trial with a follow-up period of 5 years old.

Patients in the ATG arm will receive 5 antilymphocyte globulin infusions Fresenius® (rabbit immunoglobulin antilymphocyte human T-Fresenius® said ATG) from Day 0 to Day + 4 post-transplant (day 0 one dose of 4mg / kg, day 1 one dose of 4mg/kg, day2 one dose of 4mgkg, day 3 one dose of 3 m/kg and day 4 and one final dose of 3 mg/kg) and the patients in the anti-CD25 arm will receive 2 doses of 20 mg of basiliximab (Simulect®) pn day 0 and day 4 after the graft. The maintenance immunosuppressive therapy is left to the discretion of the center.

The primary endpoint will be the clinical and histological recurrence of IgAN defined by the presence of mesangial deposits of IgA (at least 1) by immunofluorescence on a biopsy of the graft triggered by the onset of proteinuria 1g/j and/or microalbuminuria greater than 300 mg / day.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de TOULOUSE
CHU de NANTES
CHU de STRASBOURG
CHU de SAINT-ETIENNE
CHU de NANCY
CHU de NICE
CHU de BESANCON
Chu Kremlin Bicetre
Hopital Tenon
CHU de BORDEAUX
Hopital LYON Sud
CHRU de TOURS
CHU de MONTPELLIER
Hopital Pitie Salpetriere
Hopital Edouard HERRIOT

title: Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment


title: Medicoeconomic Analysis of Lobectomy Using Thoracoscopy vs Thoracotomy for Lung Cancer: a Multicentric Randomized Controlled Trial.

summary:
This is a national study that involves the participation of 600 lung cancer patients indicated that treatment is ablation of the pulmonary lobe. This technique is called lobectomy.

Lobectomy may be performed in two different ways:

Thoracotomy, which is the first reference approach and that is to make a large incision in the chest to pass between the ribs and spread the order to ablate the lobe.
By video-thoracoscopy, which is a new surgical approach consisting in practice several small incisions in the chest wall to allow the introduction of a camera and special instruments to ablate the lobe.

The mini-invasive nature of video-thoracoscopy has a positive impact on postoperative expectoration and ventilation. As a result, the incidence of postoperative respiratory complications including atelectasis, pneumonia and Acute Respiratory Distress Syndrome (ARDS) is reduced. These respiratory complications are responsible for prolonged stays in Intensive Care Unit (ICU) and overall hospitalisation. It also has an impact on recovery and quality of life when patients return home. The reduction in the incidence of complications should counterbalance the additional cost of video-thoracoscopy.

This study aims to evaluate the effectiveness of these two techniques in relation to the quality of life and the costs they generate.

Patients who agree to participate in the study were assigned to one or other of these groups (technical thoracotomy or video-thoracoscopy technique) by lot.

ReferenceCitation: Pages PB, Abou Hanna H, Bertaux AC, Serge Aho LS, Magdaleinat P, Baste JM, Filaire M, de Latour R, Assouad J, Tronc F, Jayle C, Mouroux J, Thomas PA, Falcoz PE, Marty-Ane CH, Bernard A. Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01). BMJ Open. 2017 Jun 15;7(6):e012963. doi: 10.1136/bmjopen-2016-012963.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
Centre Jean Perrin - Clermont-Ferrand
CH Avignon
CHU de Rouen
CHU de Rennes - Hôpital de Pontchaillou
CHU de Nice - Hôpital Pasteur
CHU de Poitiers
APHP Hôpital Cochin
APHM Hôpital Nord
CHU de Montpellier
HUS Strasbourg - Nouvel Hôpital Civil
CHU Dijon
HCL - Louis Pradel
APHP Hôpital de Tenon
CH Victor Dupouy
CHU Amiens

region: Bourgogne-Franche-Comté

nom_etablissement: CHU DIJON BOURGOGNE

titre: Evaluation médico-économique de la lobectomie pour cancer bronchique par vidéo-thoracoscopie et de la lobectomie par thoracotomie. Essai contrôlé randomisé multicentrique

discipline_principale: lung cancer

nom_porteur: BERNARD

prenom_porteur: Alain


title: Study of Elderly Patients With Cancer and Seen in Consultation of Geriatric Oncology in the Nord Pas-de-Calais (CONSOG).

summary: The aim of this study is to establish a common geriatric oncology medical database. The patients concerned are the patients having benefited from a geriatric oncology consultation in one of the participating centres. This database is designed with a view on the one hand to better describe to better understand this population and on the other hand to facilitate the conduct of future retrospective or prospective studies on this population. The constitution of this observatory of patients seen in consultation should facilitate the development of studies from the analysis of data collected, and occasional surveys by the rapid identification of cases. Data from this database could provide clinicians with valuable informative elements of descriptive epidemiology and concerning the organization of care in the geriatric oncology field.

lead_sponsor: Centre Oscar Lambret

location_facility:
Hospitalier Le Cateau-Cambresis
Centre de cancérologie Les Dentellières
Hôpital Saint Vincent de Paul
Centre Hospitalier d'Arras
Centre Hospitalier
Hôpital Saint-Philibert
Centre Hospitalier, Douai
CHRU de Lille
Clinique Saint Jean, Roubaix
Centre Oscar Lambret
Polyclinique de Riaumont


title: An Observational Study of the Prevalence of Patients Requiring Palliative Care in the French Anti Cancer Centers.

summary:
The purpose of this observational study is to determine the proportion of patients with a score greater than 3/10 to the questionnaire PALLIA-10.

This questionnaire is a tool provided by the French Society for Palliative Cares, aiming at helping the providers of care to identify patients who would require palliative cares.

According to the notice of the questionnaire, patients with a score greater than 3 would be taken in charge by a palliative care team. Considerong the 10 itmes of this questionnaire, it seems that a large majority of patients would have a score greater than 3 in the context of anti cancer centers.

To date, palliative teams are not designed to take in charge such an amount of patients.

time_perspective: Cross-Sectional

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole


title: A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis

acronym: ACTIVE

summary:
PHASE : IV TYPE OF STUDY : With direct benefit. DESCRIPTIVE : Multicentre, randomized, open label study. INCLUSION CRITERIA : Acute severe ulcerative colitis. OBJECTIVES : To compare the efficacy and safety of early administration of the combination therapy with infliximab and azathioprine with steroids and azathioprine in patients with acute severe ulcerative colitis treated with intravenous steroids.

STUDY TREATMENTS : All patients :

Intravenous steroids (0.8 mg/kg/day of methylprednisolone or equivalent) for 5 days.

Combination therapy arm:

Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day.

Azathioprine arm:

Steroids tapering for 3 months and Azathioprine 2-2.5 mg/kg/day.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Hopital Saint Joseph
Chu Saint Etienne
CHU NANCY - Hopital Brabois
Hopital Saint Louis
Henri Mondor Hospital
Chu Montpellier
CHU de CLERMONT FERRAND- Hopital Estain
Chu Kremlin Bicetre
CHRU Lille
CHU RENNES - Hopital Pontchaillou
Hopital Louis Mourrier
Hopital St Antoine
Chu Besancon
APHP- Hopital BEAUJON
Chu Rouen
CHU de NICE- Hopital Archet 2


title: Assessment of the Clinical Value of a Docetaxel, Cisplatin and 5-fluorouracil (DCF) Strategy Adapted to Patients for the Management of Metastatic or Locally Advanced Anal Resistant Radiochemotherapy Squamous Cell Anal Carcinoma.

summary:
Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at an early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and 5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure (including salvage surgery), cisplatin-5FU combination is the standard option but complete response is a rare event and the prognosis remains poor with most patients' death occurring in the first 12 months. Decision making for physicians in this setting is only based on retrospective studies or small phase II clinical trials including less than 20 patients. Hence, no efficient standard of care is currently available for relapsing SCCA patients who are currently treated with a palliative intent.

Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved a complete response. Three patients underwent surgery of all involved metastatic sites. A pathological complete response was observed for all of them including in metastases occurring in irradiated fields, suggesting that taxane-based chemotherapy might be an effective strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8 patients was published (Kim S et al Annals of oncology 2013). Furthermore, all complete responders were HPV 16, and high levels of specific T cell responses against Human Papillomavirus (HPV) HPV16-derived E6/E7 and telomerase were detected in 50% of complete responders suggesting the potential restoration of cancer immunosurveillance by this regimen.

Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of taxane-based chemotherapy in SCCA patients.

ReferenceCitation: Kim S, Jary M, Mansi L, Benzidane B, Cazorla A, Demarchi M, Nguyen T, Kaliski A, Delabrousse E, Bonnetain F, Letondal P, Bosset JF, Valmary-Degano S, Borg C. DCF (docetaxel, cisplatin and 5-fluorouracil) chemotherapy is a promising treatment for recurrent advanced squamous cell anal carcinoma. Ann Oncol. 2013 Dec;24(12):3045-50. doi: 10.1093/annonc/mdt396. Epub 2013 Oct 10.

ReferenceCitation: Kim S, Meurisse A, Spehner L, Stouvenot M, Francois E, Buecher B, Andre T, Samalin E, Jary M, Nguyen T, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouche O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, de la Fouchardiere C, Boulbair F, Lakkis Z, Klajer E, Jacquin M, Taieb J, Vendrely V, Vernerey D, Borg C. Pooled analysis of 115 patients from updated data of Epitopes-HPV01 and Epitopes-HPV02 studies in first-line advanced anal squamous cell carcinoma. Ther Adv Med Oncol. 2020 Dec 4;12:1758835920975356. doi: 10.1177/1758835920975356. eCollection 2020.

ReferenceCitation: Spehner L, Kim S, Vienot A, Francois E, Buecher B, Adotevi O, Vernerey D, Abdeljaoued S, Meurisse A, Borg C. Anti-Telomerase CD4+ Th1 Immunity and Monocytic-Myeloid-Derived-Suppressor Cells Are Associated with Long-Term Efficacy Achieved by Docetaxel, Cisplatin, and 5-Fluorouracil (DCF) in Advanced Anal Squamous Cell Carcinoma: Translational Study of Epitopes-HPV01 and 02 Trials. Int J Mol Sci. 2020 Sep 17;21(18):6838. doi: 10.3390/ijms21186838.

ReferenceCitation: Stouvenot M, Meurisse A, Saint A, Buecher B, Andre T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouche O, Desrame J, Zoubir M, Smith D, Ghiringhelli F, Parzy A, de la Fouchardiere C, Almotlak H, Vienot A, Jacquin M, Taieb J, Nguyen T, Vernerey D, Borg C, Kim S. Second-line treatment after docetaxel, cisplatin and 5-fluorouracil in metastatic squamous cell carcinomas of the anus. Pooled analysis of prospective Epitopes-HPV01 and Epitopes-HPV02 studies. Eur J Cancer. 2022 Feb;162:138-147. doi: 10.1016/j.ejca.2021.11.019. Epub 2022 Jan 4.

ReferenceCitation: Kim S, Francois E, Andre T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouche O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

ReferenceCitation: Kim S, Jary M, Andre T, Vendrely V, Buecher B, Francois E, Bidard FC, Dumont S, Samalin E, Peiffert D, Pernot S, Baba-Hamed N, El Hajbi F, Bouche O, Desrame J, Parzy A, Zoubir M, Louvet C, Bachet JB, Nguyen T, Abdelghani MB, Smith D, De La Fouchardiere C, Aparicio T, Bennouna J, Gornet JM, Jacquin M, Bonnetain F, Borg C. Docetaxel, Cisplatin, and 5-fluorouracil (DCF) chemotherapy in the treatment of metastatic or unresectable locally recurrent anal squamous cell carcinoma: a phase II study of French interdisciplinary GERCOR and FFCD groups (Epitopes-HPV02 study). BMC Cancer. 2017 Aug 25;17(1):574. doi: 10.1186/s12885-017-3566-0.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Regional Institute of Cancer
Curie Institute
Institute of Cancerology of Lorraine
Hospital of Belfort-Montbeliard
Pitié Salpétrière Hospital
Paul Strauss Center
Mutualist Montsouris Institute
FNLCC center Georges François Leclerc
University hospital of Besançon
Jean Mermoz Private Hospital
Oscar Lambret center
Paris Saint-Joseph Hospital Group
Saint-Antoine Hospital
European Georges Pompidou Hospital
University Robert Debré Hospital
Antoine Lacassagne Center


lead_sponsor: UNICANCER

summary: Open-label, multicenter, single arm phase II study, set up in collaboration with the "Réseau d'Expertise Français sur les Cancers ORL Rares" (REFCOR), evaluating the activity and safety of single agent pazopanib in recurrent or metastatic tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).

location_facility: Institut de Cancérologie de l'Ouest Paul Papin

title: Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma

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


title: Identification, in Patients Admitted to Intensive Care for Severe Influenza Respiratory Infection, of a Predictive Biomarker of Respiratory Distress

acronym: ANTIGRIPPE

summary: Influenza is a major cause of morbidity and mortality. The investigators first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital de la Croix Rousse-service réanimation adulte médicale

location_facility: Hôpital de la Croix Rousse-service réanimation adulte chirurgicale

location_facility: Centre de Biologie et de Pathologie Nord

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: ANTIGRIPPE

titre: Identification, chez les patients admis en réanimation pour une infection respiratoire grippale sévère, d'un marqueur biologique prédictif de l'évolution vers un tableau de détresse respiratoire nécessitant des soins lourds de réanimation.

discipline_principale: infectieux

nom_porteur: CASALEGNO

prenom_porteur: Jean-Sébastien


title: Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)

acronym: BICAFMS

summary:
Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly information processing speed (IPS) which also influences with other cognitive functions such as attention, working memory and executive functions. The investigators validated a computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT), a test of the IPS, and two measures of episodic memory. On the same principle, the investigators propose to validate a short computerized battery to improve the feasibility (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized test of visual episodic memory.

Purpose: to establish the screening value of a brief computerized cognitive assessment (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as compared to a reference battery (MACFIMS).

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Bayer

location_facility: Centre Hospitalier Saint Vincent de Paul


title: Identification of Composite Clinical and Lab Scores Associated With a Favorable Clinical Response With Thiopurines in Patients With IBD (Inflammatory Bowel Disease): an International Clinical Trial

summary: Inflammatory bowel disease (IBD) groups together Crohn's Disease (CD) and ulcerative colitis (UC). Its prevalence is high representing approximately 0.4% of the population. The peak incidence for these diseases ranges between 2 and 30 years of age with a second peak for CD recently reported at 60. These diseases develop over time into complications requiring in 2/3 of cases surgical resection procedures in CD and colectomy in over 20% of cases. Cohort data has recently shown that the early use of azathioprine from the first year would decrease the need for surgery. Aside from biologics, azathioprine is the most widely used immunosuppressant in IBD management. Its metabolism is highly variable in the overall population since over 10% of patients are slow metabolizers and 15% fast metabolizers. This explains partly treatment failures and side effects with thiopurines. A lot of research has shown that metabolite measurement of azathioprine (6-TGN end methylated derivatives) could be used clinically even if these results remain controversial. In fact, their positive predicative value (PPV) in clinical response does not exceed 60%. This costly testing cannot be done everywhere, is not reimbursed by national health services, and may not be used in some countries. It is, however, key in order optimize these drugs at a time when only two anti-TNFs are possible in the event of failure on thiopurines. Older studies have shown that MCV and lymphonenia could be markers for thiopurine impregnation. Recently, an American study provided a mathematic formula enabling to achieve over 80% PPV for the clinical response on AZA but this calculation needs to be confirmed and it is, moreover, patented (costly).

location_facility:
CH Lyon Sud
CHR Orléans
CHU Montpellier
CHRU Lilles
CHU Nice
CHU Nantes - Hôtel-Dieu
CHU Reims
CHU Rennes
CHU Saint-Etienne
CHU Caen
CHU Bordeaux
CHU Dijon
CHU Jean Minjoz
CHU Nancy
Hôpital Saint-Antoine


title: Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.

summary: This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).

ReferenceCitation: Kornowski R, Chevalier B, Verhoye JP, Holzhey D, Harnath A, Schӓfer U, Teiger E, Manigold T, Modine T, Souteyrand G, Champagnac D, Oh JK, Li S, Tchetche D; VIVA Investigators. Transcatheter Aortic Valve Implantation for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device (from the Prospective VIVA Post Market Study). Am J Cardiol. 2021 Apr 1;144:118-124. doi: 10.1016/j.amjcard.2020.12.047. Epub 2020 Dec 28.

ReferenceCitation: Tchetche D, Chevalier B, Holzhey D, Harnath A, Schafer U, Teiger E, Manigold T, Modine T, Souteyrand G, Champagnac D, Oh JK, Li S, Verhoye JP, Kornowski R; VIVA Investigators. TAVR for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device: 1-Year Results From the Prospective VIVA Postmarket Study. JACC Cardiovasc Interv. 2019 May 27;12(10):923-932. doi: 10.1016/j.jcin.2019.02.029.

lead_sponsor: Medtronic Bakken Research Center

location_country: Germany Israel Italy France

location_facility: Azienda Ospedaliero Universitaria Pisana


lead_sponsor: ERYtech Pharma

summary:
A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment.

Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an essential nutriment for pancreatic cancer cells which have no or low level of ASNS.

by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.

in selected patients having no or low ASNS, may provide a new therapeutic approach.

ReferenceCitation: Bachet JB, Blons H, Hammel P, Hariry IE, Portales F, Mineur L, Metges JP, Mulot C, Bourreau C, Cain J, Cros J, Laurent-Puig P. Circulating Tumor DNA is Prognostic and Potentially Predictive of Eryaspase Efficacy in Second-line in Patients with Advanced Pancreatic Adenocarcinoma. Clin Cancer Res. 2020 Oct 1;26(19):5208-5216. doi: 10.1158/1078-0432.CCR-20-0950. Epub 2020 Jun 30.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Hammel P, Fabienne P, Mineur L, Metges JP, Andre T, De La Fouchardiere C, Louvet C, El Hajbi F, Faroux R, Guimbaud R, Tougeron D, Bouche O, Lecomte T, Rebischung C, Tournigand C, Cros J, Kay R, Hamm A, Gupta A, Bachet JB, El Hariry I. Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial. Eur J Cancer. 2020 Jan;124:91-101. doi: 10.1016/j.ejca.2019.10.020. Epub 2019 Nov 21. Erratum In: Eur J Cancer. 2020 May;130:275-276.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

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

location_facility: Centre Hospitalier Departemental Vendee - Les Oudairies

location_facility: Institut Regional du Cancer-Montpellier Val d'Aurelle

title: Phase II, Randomized, Controlled, Clinical Trial Exploring Efficacy and Safety of ERY001 (L-asparaginase Encapsulated in Red Blood Cells) in Association With Gemcitabine or FOLFOX4 in Second-line Therapy for Patients With Progressive Metastatic Pancreatic Carcinoma


acronym: ANTHARTIC

lead_sponsor: University Hospital, Limoges

summary:
Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with shockable rhythm. In mechanically ventilated patients who were resuscitated after out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive for infectious complications and especially for ventilator-associated pneumonia (VAP).

Despite high incidence of VAP and other infectious complications, it is not currently recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could be decreased if an antibiotic therapy was systematically given to patient treated with mild therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less infectious complications but also decreased morbidity and mortality related to these complications when antibiotic therapy was given early to patients treated with therapeutic hypothermia after cardiac arrest.

ReferenceCitation: Francois B, Cariou A, Clere-Jehl R, Dequin PF, Renon-Carron F, Daix T, Guitton C, Deye N, Legriel S, Plantefeve G, Quenot JP, Desachy A, Kamel T, Bedon-Carte S, Diehl JL, Chudeau N, Karam E, Durand-Zaleski I, Giraudeau B, Vignon P, Le Gouge A; CRICS-TRIGGERSEP Network and the ANTHARTIC Study Group. Prevention of Early Ventilator-Associated Pneumonia after Cardiac Arrest. N Engl J Med. 2019 Nov 7;381(19):1831-1842. doi: 10.1056/NEJMoa1812379.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

location_facility: CH Brive La Gaillarde - Service de Réanimation

location_facility: AP-HP - Hôpital Cochin - Service de Réanimation

location_facility: CHU de Limoges - Service de réanimation polyvalente

location_facility: AP-HP - Hôpital Européen Georges Pompidou - Service de Réanimation

location_facility: AP-HP - Hôpital Lariboisière - Service de Réanimation

location_facility: AP-HP - Hôpital pointcaré - Service de Réanimation

title: Prevention of Early Ventilator-associated Pneumonia With Antibiotic Therapy in Patients Treated With Mild Therapeutic Hypothermia After Cardiac Arrest.

nom_etablissement: CHU  DE  LIMOGES

acronyme: ANTHARTIC

titre: Prévention des pneumopathies acquises sous ventilation mécanique (PAVM) précoce par antibioprothérapie et chez les patients sous hypothermie après arrêt cardiaque. Essai thérapeutique randomisé en double aveugle.

discipline_principale: anesthésiologie / réanimation

nom_porteur: FRANCOIS

prenom_porteur: Bruno


title: A Dose-finding Phase I/II Trial of Daunorubicin and Cytarabine Combined to Fractionated Mylotarg® as Re-induction Treatment in Patients With First Relapse of Acute Myeloid Leukemia

summary: For several years, the effective standard induction chemotherapy for AML has been limited to the association of anthracycline and aracytine. GO is the first effective targeted antibody used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated doses of GO used as a single agent for treatment of adult AML patients in first relapse. In the present study the possibility of combining fractionated doses of GO to escalated doses of a 3+7 regimen old is studied in relapsed AML patients > 50 and <70 years.

lead_sponsor: Acute Leukemia French Association

location_facility:
Hopital Saint-Louis
CHU
IGR
CH
St Antoine Hospital
Hopital Avicenne
Hopital Edouard Herriot
Hopital Percy
CNLCC


title: Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions

acronym: EPIRMEX

summary:
The survival of premature babies increased during the last decades. However, the neurocognitive long term development of these children is worrying, as demonstrated by EPIPAGE 1 study.

These children present high risk of deficits such as cognitive deficits, adaptive malfunction, behavior disorders and difficulties in school learning.

Understanding the specific neuropsychological disorders at the origin of these deficits is an important objective. Studies realized at school age showed that many premature children have executive functions (EF) disorders. However the specific nature of these disorders and the neuropathology associated are unknown.

The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA and to correlate MRI findings with executives functions and neurodevelopmental outcome

lead_sponsor: University Hospital, Tours

location_facility: Médecine Infantile - Néonatologie - Périnatologie

location_facility: Service de Pédiatrie Néonatale et Réanimation

location_facility: Médecine Néonatale et Réanimation Pédiatrique

location_facility: Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE

location_facility: Service de Réanimation pédiatrique, Néonatologie