title: Randomised Phase II Study in Metastatic Pancreatic Cancer Evaluating FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem in First-line

acronym: PANOPTIMOX

summary:
The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease with the survival median of 2-4 months without chemotherapy.

Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until, the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities of this treatment are hematological, gastrointestinal and neuropathy with apparition of sensitive neuropathy, reversible, related to oxaliplatin.

These results are on a population under 76 years old. In this study, the median age of patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more than 65 years old. Given the increase of proportion of patients than more of 65 years old with pancreatic cancer and given the increase of life expected, it is important to know the effectiveness and tolerance of such treatment for patient older than 65 years and 76 years.

FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4 cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance known between this 2 treatments witch limit toxicities and preserve quality of life of patients. A Phase II trial testing this treatment regimen to classical regimen of gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of treatment.

The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8 cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference regimen.

ReferenceCitation: Dahan L, Williet N, Le Malicot K, Phelip JM, Desrame J, Bouché O, Petorin C, Malka D, Rebischung C, Aparicio T, Lecaille C, Rinaldi Y, Turpin A, Bignon AL, Bachet JB, Seitz JF, Lepage C, François E; PRODIGE 35 Investigators/Collaborators. Randomized Phase II Trial Evaluating Two Sequential Treatments in First Line of Metastatic Pancreatic Cancer: Results of the PANOPTIMOX-PRODIGE 35 Trial. J Clin Oncol. 2021 Oct 10;39(29):3242-3250. doi: 10.1200/JCO.20.03329. Epub 2021 Jul 21.

name: Department of Digestive Oncology, La Timone, Aix Marseille Université, Marseille, France

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

name: Hepatogastroenterology Department, University Hospital of Saint-Etienne, Saint-Etienne, France

family: Williet

full_name: Nicolas Williet

given: Nicolas

name: Biostatistics Department, Fédération Francphone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231 University of Burgundy and Franche Comté, Dijon, France

family: Le Malicot

full_name: Karine Le Malicot

given: Karine

family: Phelip

full_name: Jean-Marc Phelip

given: Jean-Marc

name: Cancerology Institute, Jean-Mermoz Private Hospital, Lyon, France

family: Desrame

full_name: Jérôme Desrame

given: Jérôme

name: Department of Digestive Oncology, CHU Reims, Reims, France

family: Bouché

full_name: Olivier Bouché

given: Olivier

name: Hepatogastroenterology Department, Estaing University Hospital, Clermont Ferrand, France

family: Petorin

full_name: Caroline Petorin

given: Caroline

name: Cancerology Department, Gustave Roussy Institute, Villejuif, France

family: Malka

full_name: David Malka

name: Cancerology Department, Daniel Hollard Institute, Grenoble, France

family: Rebischung

full_name: Christine Rebischung

given: Christine

name: Department of Gastroenterology and Digestive Oncology, Saint Louis Hospital, APHP, Paris, France

family: Aparicio

full_name: Thomas Aparicio

given: Thomas

name: Cancerology Department, Bordeaux Nord Polyclinic, Bordeaux, France

family: Lecaille

full_name: Cédric Lecaille

given: Cédric

name: Hepatogastroenterology Department, European Hospital of Marseille, Marseille, France

family: Rinaldi

full_name: Yves Rinaldi

given: Yves

name: Department of Medical Oncology, University Lille, CNRS UMR9020, Inserm UMR-S 1277—Canther—Cancer Heterogeneity, Plasticity and Resistance to Therapies, CHU Lille, Lille, France

family: Turpin

full_name: Anthony Turpin

given: Anthony

name: Hepatogastroenterology Department, University Hospital of Caen, Caen, France

family: Bignon

full_name: Anne-Laure Bignon

given: Anne-Laure

name: Sorbonne University, UPMC, IUC, Paris 6, Hepato-Gastroenterology and Digestive Oncology Department, Pitié Salpêtrière Hospital, Paris, France

family: Bachet

full_name: Jean-Baptiste Bachet

given: Jean-Baptiste

family: Seitz

full_name: Jean-François Seitz

given: Jean-François

name: Hepatogastroenterology and Cancerology Department, Dijon Bourgogne Hospital, Dijon, France

name: Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231 University of Burgundy and Franche Comté, Dijon, France

family: Lepage

full_name: Come Lepage

given: Come

name: Cancerology Department, Antoine Lacassagne Centre, Nice, France

family: François

full_name: Eric François

given: Eric

name: for the PRODIGE 35 Investigators/Collaborators

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

location_facility: Hôpital de la Source -service HGE et cancérologie digestive

location_facility: CHU AP - HP - Hôpital Européen Georges Pompidou

location_facility: Hôpital de la Source- service d'oncologie

location_facility: Institut Daniel Hollard / Groupe Hospitalier Mutualiste


title: Emergence of Resistance in Intestinal Microflora During Carbapenem Treatments

acronym: ERIC

summary: The use of carbapenems, very broad spectrum antibiotics of last resort, is becoming more common due to the increased prevalence in the hospital and community of extended spectrum β-lactamase (ESBL) producing gram-negative bacilli (GNB), including CTX-M type, which are resistant to all other β-lactam antibiotics. Meanwhile, it creates a selective pressure towards emergence of strains which are also resistant to carbapenems, placing patients in a catastrophic situation of therapeutic dead-end. A better understanding of the mechanisms of emergence of BGN resistant to carbapenems is necessary to optimize their use and undertake preventive measures to preserve their effectiveness. The aim of the study is to evaluate and describe the emergence of carbapenem-induced resistant GNB in patient intestinal microflora.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Grall N, Lazarevic V, Gaïa N, Couffignal C, Laouénan C, Ilic-Habensus E, Wieder I, Plesiat P, Angebault C, Bougnoux ME, Armand-Lefevre L, Andremont A, Duval X, Schrenzel J. Unexpected persistence of extended-spectrum β-lactamase-producing Enterobacteriaceae in the faecal microbiota of hospitalised patients treated with imipenem. Int J Antimicrob Agents. 2017 Jul;50(1):81-87. doi: 10.1016/j.ijantimicag.2017.02.018. Epub 2017 May 10.

family: Grall

full_name: N. Grall

given: N.

sequence: first

family: Lazarevic

full_name: V. Lazarevic

given: V.

sequence: additional

family: Gaïa

full_name: N. Gaïa

family: Couffignal

full_name: C. Couffignal

given: C.

family: Laouénan

full_name: C. Laouénan

family: Ilic-Habensus

full_name: E. Ilic-Habensus

given: E.

family: Wieder

full_name: I. Wieder

given: I.

family: Plesiat

full_name: P. Plesiat

given: P.

family: Angebault

full_name: C. Angebault

family: Bougnoux

full_name: M.E. Bougnoux

family: Armand-Lefevre

full_name: L. Armand-Lefevre

given: L.

family: Andremont

full_name: A. Andremont

given: A.

family: Duval

full_name: X. Duval

given: X.

family: Schrenzel

full_name: J. Schrenzel

given: J.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: International Journal of Antimicrobial Agents

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Louis Mourier
Hôpital Bichat-Claude Bernard
Hôpital Paul Brousse
Hôpital Saint-Louis
Hôpital Beaujon

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Multicentre, Randomized, Parallel Group, Non-inferiority, Open-label Study Aiming at Comparing the Healing Rates (With Blinded Assessment Based on Photographs) of TULLEGRAS M.S.® With URGOTUL® in the Treatment of Surgical Acute Wounds.

summary: Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Mylan Inc.

location_facility:
Research facility ORG-001133
Research facility ORG-001360
Research facility ORG-001101
Research facility ORG-001107
Research facility ID ORG-001189
Research facility ORG-001166
Research facility ORG-001088
Research facility ID ORG-001263
Research facility ORG-001105
Research facility ORG-001102
Research facility ORG-001099
Research facility ID ORG-001099
Research facility ID ORG-001265
Research facility ORG-001093
Research facility ID ORG-001278
Research facility ORG-001097
Research facility ID ORG-001134
Research facility ID ORG-001264
Research facility ID ORG-001276
Research facility ID ORG-001190
Research facility ORG-001132
Research facility ORG-001136
Research facility ORG-001137
Research facility ID ORG-001223
Research facility ID ORG-001222
Research facility ID ORG-001105
Research facility ORG-001089
Research facility ID ORG-001221
Research facility ORG-001090
Research facility ID ORG-001220
Research facility ID ORG-001133
Research facility ORG-001096
Research facility ID ORG-001088

intervention_type: Device

lead_sponsor_type: industriel


acronym: CLEAN

summary:
Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections.

This aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.

primary_purpose: Prevention

ReferenceCitation: Buetti N, Ruckly S, Lucet JC, Bouadma L, Schwebel C, Mimoz O, Timsit JF. Ultrasound guidance and risk for intravascular catheter-related infections among peripheral arterial catheters: a post-hoc analysis of two large randomized-controlled trials. Ann Intensive Care. 2020 Jul 8;10(1):89. doi: 10.1186/s13613-020-00705-4.

family: Buetti

full_name: Niccolò Buetti

given: Niccolò

family: Ruckly

full_name: Stéphane Ruckly

given: Stéphane

family: Lucet

full_name: Jean-Christophe Lucet

given: Jean-Christophe

family: Bouadma

full_name: Lila Bouadma

given: Lila

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Mimoz

full_name: Olivier Mimoz

given: Olivier

family: Timsit

full_name: Jean-François Timsit

currency_apc_doaj: GBP

journal_name: Annals of Intensive Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Maunoury F, Farinetto C, Ruckly S, Guenezan J, Lucet JC, Lepape A, Pascal J, Souweine B, Mimoz O, Timsit JF. Cost-effectiveness analysis of chlorhexidine-alcohol versus povidone iodine-alcohol solution in the prevention of intravascular-catheter-related bloodstream infections in France. PLoS One. 2018 May 25;13(5):e0197747. doi: 10.1371/journal.pone.0197747. eCollection 2018.

family: Maunoury

full_name: Franck Maunoury

given: Franck

family: Farinetto

full_name: Christian Farinetto

given: Christian

family: Guenezan

full_name: Jeremy Guenezan

given: Jeremy

family: Lepape

full_name: Alain Lepape

given: Alain

family: Pascal

full_name: Julien Pascal

given: Julien

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

ReferenceCitation: Mimoz O, Lucet JC, Kerforne T, Pascal J, Souweine B, Goudet V, Mercat A, Bouadma L, Lasocki S, Alfandari S, Friggeri A, Wallet F, Allou N, Ruckly S, Balayn D, Lepape A, Timsit JF; CLEAN trial investigators. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial. Lancet. 2015 Nov 21;386(10008):2069-2077. doi: 10.1016/S0140-6736(15)00244-5. Epub 2015 Sep 18.

title: Skin antisepsis with chlorhexidine–alcohol versus povidone iodine–alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial

ReferenceCitation: Goudet V, Timsit JF, Lucet JC, Lepape A, Balayn D, Seguin S, Mimoz O. Comparison of four skin preparation strategies to prevent catheter-related infection in intensive care unit (CLEAN trial): a study protocol for a randomized controlled trial. Trials. 2013 Apr 27;14:114. doi: 10.1186/1745-6215-14-114.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

location_facility:
Lyon University Hospital
Estain University Hospital
Angers University Hospital
Poitiers University Hospital
Bichat-Claude Bernard Hospital


intervention_type: Drug

ipd_sharing_description: IPD will not be shared at an individual level, those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_facility:
Centre Léon Berard
Centre Antoine Lacassagne
Centre Oscar Lambret
Institut Curie
Institut Gustave Roussy

ipd_sharing: No

type: EudraCT Number

source: euctr

title: A PHASE II, OPEN-LABEL, MULTICENTER TRIAL OF CABAZITAXEL IN PATIENTS WITH RECURRENT OR METASTATIC HEAD AND NECK CANCER AFTER FAILURE OF CISPLATIN, CETUXIMAB AND TAXANES.

summary: This is a multi-center phase II study assessing whether cabazitaxel could be efficient for treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes.


title: Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

summary: This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.

status: Terminated

ReferenceCitation: Vanderhoof J, Moore N, de Boissieu D. Evaluation of an Amino Acid-Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):531-533.

lead_sponsor: Mead Johnson Nutrition

location_facility:
Hôpital Necker Enfants Malades
Centre médical
Hôpital Saint Vincent de Paul
Hôpital Armand Trousseau
Médecine Infantile 1

intervention_type: Other

status_simplified: Unknown


title: Early Neuroinflammatory Changes as a Prognostic Marker in Clinically Isolated Syndromes Patients.

acronym: USPIO-CIS

summary: While significant progress has been made on medical imagery in recent years in the individualization of different lesions in the nervous system for demyelination, axonal loss, atrophy, little progress has been made in the specific recognition the inflammatory process. Yet this point is essential since the currently available treatments have a partial impact mainly on the inflammatory component and that many uncertainties remain about the links between inflammation and tissue destruction affecting myelin and axons. The recent discovery of a macrophage cell marker in the CNS, more specific (USPIO) of inflammation gives us the opportunity to answer important questions which one can sense that this could have a significant impact on therapeutic drug monitoring of these patients. This study will involve 50 patients recruited in five French centers (Marseille, Paris, Reims, Rennes, Toulouse) from the earliest manifestations of the disease with clinical and MRI scheduled for the first 3 years of their disease.

ReferenceType: result

ReferenceCitation: Crimi A, Commowick O, Maarouf A, Ferré JC, Bannier E, Tourbah A, Berry I, Ranjeva JP, Edan G, Barillot C. Predictive value of imaging markers at multiple sclerosis disease onset based on gadolinium- and USPIO-enhanced MRI and machine learning. PLoS One. 2014 Apr 1;9(4):e93024. doi: 10.1371/journal.pone.0093024. eCollection 2014.

family: Crimi

full_name: Alessandro Crimi

given: Alessandro

family: Commowick

full_name: Olivier Commowick

family: Maarouf

full_name: Adil Maarouf

given: Adil

family: Ferré

full_name: Jean-Christophe Ferré

family: Bannier

full_name: Elise Bannier

given: Elise

family: Tourbah

full_name: Ayman Tourbah

given: Ayman

family: Berry

full_name: Isabelle Berry

given: Isabelle

family: Ranjeva

full_name: Jean-Philippe Ranjeva

given: Jean-Philippe

family: Edan

full_name: Gilles Edan

given: Gilles

family: Barillot

full_name: Christian Barillot

currency_apc_doaj: USD

journal_name: PLoS ONE

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

repository_normalized: HAL

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Predictive Value of Imaging Markers at Multiple Sclerosis Disease Onset Based on Gadolinium- and USPIO-Enhanced MRI and Machine Learning

lead_sponsor: Rennes University Hospital

location_facility:
Purpan Hospital
La Pitie-Salpaetriere Hospital (APHP)
Rennes University Hospital
Maison Blanche Hospital
La Timone University Hospital (APHM)


title: A Phase I/II Study Investigating the Combination of RAD001 and Rituximab in Patients With Non-Hodgkin's Lymphomas

summary:
This study is an open label, multicenter study with two phases:

Phase I is a dose escalation study of RAD001 in combination with one injection of Rituximab 375 mg/m² per week during 4 weeks (28 days) in patients CD20 positive non-Hodgkin's lymphomas to determine the dose limiting toxicities (DLTs) and maximum tolerated dose (MTD). The purpose of the study is to assess the feasibility of the combination based on - rate of dose limiting toxicities (DLT) and PK drug-drug interaction (DDI).
Phase II will define the efficacy and safety profile of RAD001 and Rituximab combination at the RP2D in patients with lymphomas.

Patients with lymphomas will be treated at the RP2D established during phase I and evaluated for clinical benefit rate, comprising complete responses (CR + CRu), partial responses (PR) and stable disease (SD), and time to progression using the IWG criteria for treatment response.

Induction therapy will follow the same schedule than during the phase I study.

Maintenance therapy: Monthly cycles for up to 2 years with:

Daily RAD001 at the same dose than during induction therapy.
Rituximab infusion every other cycle at 375 mg/m2 that correspond to the usual maintenance schedule for Rituximab.

Response to therapy will be assessed between day 42 and day 49, then every two months.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Service Hématologie - Institut Gustave Roussy

location_facility: Service des Maladies du Sang - CHRU de Lille

location_facility: Service Hématologie - Centre Henri Becquerel

location_facility: Service Hématologie - Hôtel Dieu de NANTES


title: A Dose Escalation Phase I Study of Asparec®(mPEG-R-Crisantaspase) Administered as Intravenous (IV) Infusion in Patients With Relapsed or Refractory Hematological Malignancies

summary: This study is an open label, multicenter study with a dose escalation of Asparec® administered once every two to four weeks for two administrations. The primary objective of this study is to determine the Maximum Tolerated Dose following one single dose of Asparec when administered in a population of patients with relapsed or refractory hematological malignancies, as measured by Dose Limiting toxicities. There are secondary objectives which are to evaluate the safety of Asparec and to determine the PK profile as assessed by measurement of plasma L-asparaginase enzymatic activity following single and repeated doses of Asparec. Patients response rate will be evaluated and Anti-Asparec antibodies will be measured.

enrollment_type: Anticipated

lead_sponsor: Jazz Pharmaceuticals

location_facility:
Hôpital Henri Mondor
Hospices Civils de Lyon
Institut Claudius Regaud
Hôpitaux du CHU de Nantes
Centre Henri Becquerel

intervention_type: Biological


title: Plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels During Emergency Management of Rhabdomyolysis: Predicting Renal Failure

summary: This research project consists of a prospective diagnostic study conducted on patients with clinical suspicion of rhabdomyolysis admitted to the emergency rooms of the University Hospitals of Nimes, Montpellier, Paris, Nice and Toulon Inter Army Hospital. The main objective of this study is to determine whether the plasma level of Neutrophil Gelatinase Associated Lipocalin (NGAL) may be retained as a predictor of acute renal failure (ARF) occurring within 48 hours after admission for rhabdomyolysis.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Contribution of Platelet Rich Fibrin (PRF) After Tooth Avulsion in the Prevention of Healing Delay and of Jawbone Osteochemonecrosis Induced by Bisphosphonates

acronym: OCN/PRF

summary: The main objective of our study is to assess, after tooth extraction, the efficacity of PRF in the prevention of healing delay and of jawbone osteochemonecrosis induced by bisphosphonates

study_start_date_type: Actual

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
Chu de Reims
Scm Bally Curien
Chu de Dijon
Chu de Nancy
Chr Metz Thionville

intervention_type: Procedure


title: Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study

acronym: METRO

summary:
Patients with Multiple Myeloma (MM) are at increased risk of venous thromboembolic event, especially in newly diagnosed patients and during induction treatment with thalidomide in combination with dexamethasone. This association was mainly heightened during the 3 first months of chemotherapy.

Several coagulation abnormalities have been described. Laboratory tests measuring the overall thrombophilic tendency might be useful to assess thrombosis risk.

The aim of this study is to compare thrombin generation by calibrated automated thrombogram during the 3 first cycles of chemotherapy in patients with newly diagnosed MM.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de rhumatologie - CHU de Saint Etienne

location_facility: Service de Médecine Interne - CHU de Saint Etienne


lead_sponsor: University Hospital, Limoges

acronym: BECONNEC

location_facility: CHU de Toulouse, Service d'Ophtalmologie

title: Effect of Bevacizumab Subconjunctival Injections on Corneal Newvessels

summary:
Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed to reduce newascularization induced by gastric cancer or age-related macular degeneration. A few reports have been published showing the interest of VEGF inhibitors to treat corneal newvessels, but no randomized study has been achieved to date.

This study is designed to assess the efficacy of Bevacizumab, a VEGF inhibitor monoclonal antibody, to reduce the surface of corneal newvessels in when compared to placebo


title: Delayed Angioplasty Postconditioning in STEMI Patients

acronym: PRIME

summary:
The investigators previously reported that angioplasty postconditioning reduces infarct size (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital admission. Animal studies have suggested that the time window for applying brief episodes of ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow, i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window might be larger in humans, i.e. whether STEMI patients might be protected several minutes after undergoing spontaneous reperfusion before admission coronary angiography.

Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade > 1 were eligible for that study. Angioplasty postconditioning was completed as already published and infarct size was assessed by measuring cardiac enzymes release.

ReferenceCitation: Roubille F, Mewton N, Elbaz M, Roth O, Prunier F, Cung TT, Piot C, Roncalli J, Rioufol G, Bonnefoy-Cudraz E, Wiedemann JY, Furber A, Jacquemin L, Willoteaux S, Abi-Khallil W, Sanchez I, Finet G, Sibellas F, Ranc S, Boussaha I, Croisille P, Ovize M. No post-conditioning in the human heart with thrombolysis in myocardial infarction flow 2-3 on admission. Eur Heart J. 2014 Jul 1;35(25):1675-82. doi: 10.1093/eurheartj/ehu054. Epub 2014 Feb 28.

family: Roubille

full_name: F. Roubille

given: F.

family: Mewton

full_name: N. Mewton

given: N.

family: Elbaz

full_name: M. Elbaz

given: M.

family: Roth

full_name: O. Roth

given: O.

family: Prunier

full_name: F. Prunier

family: Cung

full_name: T. T. Cung

given: T. T.

family: Piot

full_name: C. Piot

given: C.

family: Roncalli

full_name: J. Roncalli

given: J.

family: Rioufol

full_name: G. Rioufol

given: G.

family: Bonnefoy-Cudraz

full_name: E. Bonnefoy-Cudraz

given: E.

family: Wiedemann

full_name: J. Y. Wiedemann

given: J. Y.

family: Furber

full_name: A. Furber

given: A.

family: Jacquemin

full_name: L. Jacquemin

given: L.

family: Willoteaux

full_name: S. Willoteaux

given: S.

family: Abi-Khallil

full_name: W. Abi-Khallil

given: W.

family: Sanchez

full_name: I. Sanchez

given: I.

family: Finet

full_name: G. Finet

family: Sibellas

full_name: F. Sibellas

family: Ranc

full_name: S. Ranc

family: Boussaha

full_name: I. Boussaha

family: Croisille

full_name: P. Croisille

given: P.

family: Ovize

full_name: M. Ovize

location_facility: Service de Cardiologie, Hôpital Rangueil

location_facility: Service de Cardiologie, Hôpital Arnaud de Villeneuve

location_facility: Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel

location_facility: Service de Cardiologie, Hôpital Emile Müller


title: Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis

summary: The purpose of this study is to evaluate the efficacy of an active rehabilitation program on disability and quality of life of patients affected by dermatomyositis and polymyositis.

ReferenceCitation: Tiffreau V, Rannou F, Kopciuch F, Hachulla E, Mouthon L, Thoumie P, Sibilia J, Drumez E, Thevenon A. Postrehabilitation Functional Improvements in Patients With Inflammatory Myopathies: The Results of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Feb;98(2):227-234. doi: 10.1016/j.apmr.2016.09.125. Epub 2016 Oct 24.

family: Tiffreau

full_name: Vincent Tiffreau

given: Vincent

family: Rannou

full_name: François Rannou

given: François

family: Kopciuch

full_name: François Kopciuch

family: Hachulla

full_name: Eric Hachulla

given: Eric

family: Mouthon

full_name: Luc Mouthon

given: Luc

family: Thoumie

full_name: Philippe Thoumie

given: Philippe

family: Sibilia

full_name: Jean Sibilia

given: Jean

family: Drumez

full_name: Elodie Drumez

given: Elodie

family: Thevenon

full_name: André Thevenon

given: André

journal_name: Archives of Physical Medicine and Rehabilitation

lead_sponsor: University Hospital, Lille

location_facility: Centre hospitalier universitaire de Rouen


title: Adipocytes, Insulin Resistance and Immunity: Evolution of Interleukin 7, Fat Mass and Metabolic Profile Before and After Transplantation

summary: Three different white adipose tissue-related disorders, whether due to its excess (obesity), absence (lipoatrophies) or aberrant distribution (lipodystrophies), are paradoxically able to induce metabolic insulin resistance syndrome. The respective roles played by quantitative and qualitative anomalies of adipose tissue, gluco- and lipo-toxicity, liver and muscle insulin resistance, low-grade fat inflammation and immune alterations are not yet perfectly understood. In contrast to most organ transplantations that are often complicated by post-transplantation diabetes, diabetes cell therapy is associated with body weight loss, which is possibly related to the antiadipogenic effects of mTOR inhibitors (rapamycin or sirolimus). The aim of this study is thus to determine and monitor blood interleukin-7 and other cytokine levels; metabolic parameters; and fat mass distribution with DEXA and RMN, before and after a immunosuppressive regimen in patients receiving different kinds of transplantation (liver, kidney or islets) with normal weight and no type 2 diabetes before transplantation. In these patients, blood samples will be taken before and after transplantation, as will adipose tissue during the transplantation surgery, in order to constitute a plasma serum, gene and tissue bank for improving our knowledge of disorders linking fat mass, insulin resistance and immunity, especially post-transplantation diabetes.

time_perspective: Other

location_facility:
Lille University Hospital
Rouen University Hospital
Amiens University Hospital
Caen University Hospital
Reims University Hospital


title: The Pre-treatment Detection of Circulating, Functional, Prostate Cells Among Adenocarcinoma Patients: an Evaluation of the EPISPOT Technique

summary: The primary objective of this study is to evaluate the predictive value (in terms of remission) of a new technique for detecting circulating, functional, prostate cells among patients with localized adenocarcinoma of the prostate, and prior to any treatment.

status: Active, not recruiting

study_completion_date_type: Anticipated

location_facility: CHU de Montpellier - Hôpital Lapeyronie - Plateforme LCCRH

location_facility: Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque

status_simplified: Ongoing


lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

acronym: CAPRA

location_facility:
Centre Léon Berard
Hopital Beaujon
Institut Claudius Regaud
Institut Curie
Hôpital Privé Saint Joseph

title: Phase I/II Study of Induction Chemotherapy With Weekly RAD001, Carboplatin and Paclitaxel in Unresectable or Inoperable Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

summary:
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus together with carboplatin and paclitaxel in treating patients with locally advanced head and neck cancer that cannot be removed by surgery.


lead_sponsor: Institut Cancerologie de l'Ouest

acronym: SKINUX

location_facility: Centre Hospitalier Départemental Les Oudairies

title: Pre-emptive Cycline Treatment on Cetuximab-induced Skin Toxicity in Patients With Metastatic Colorectal Cancer Treated With an Intensified FOLFIRI.

summary: The aim of this study is to test the role of cycline in the prevention of acne-like skin rash in metastatic colorectal patients treated with Cetuximab and intensified FOLFIRI.


title: Maâthermes a Randomised Controlled Trial of Spa Treatment of Overweight and Obesity

acronym: MAATHERMES

summary:
Public health campaigns and industry-supported changes in our food supply have obviously failed to control the epidemic to date. However, customized life style modification programs (LSMP) comprising diet, physical activity and behavioral therapy (a set of principles designed to help patients achieve their goals) induce weight loss of 10% of baseline body weight after 16 to 26 weeks of intervention . Long-term weight control is then facilitated by an appropriate weight-loss maintenance strategy such as continued patient-therapist contact (whether provided in person or by telephone or e-mail). This strategy allows patients to stabilize at an average of 5% and 3% loss of baseline body weight after 1 and 2 years, respectively. Numerous reports have concluded that this modest weight loss contributes to important health benefits.

However, the high dropout rate during weight-management strategies presumably means that treatment is mainly effective in highly motivated patients, as the highest success rates are likely to be reported among study completers. Many individuals appear to conclude that the benefits of weight-management strategies are not worth the cost (i.e. time, money, and continued unrewarding efforts). This underlines the critical need to implement new, practical and affordable strategies to induce and maintain weight loss that can be achieved by most patients.

The main objective of this study is to test the hypothesis that a 3 week intensive course of spa therapy can reduce the weight (and/or BMI) of overweight or obese patient at 14 months (BMI from 27 to 35).

ReferenceType: background

ReferenceCitation: Péneau S, Thibault H, Meless D, Soulié D, Carbonel P, Roinsol D, Longueville E, Sérog P, Deheeger M, Bellisle F, Maurice-Tison S, Rolland-Cachera MF. Anthropometric and behavioral patterns associated with weight maintenance after an obesity treatment in adolescents. J Pediatr. 2008 May;152(5):678-84. doi: 10.1016/j.jpeds.2007.09.053. Epub 2007 Nov 26.

ReferenceCitation: Rolland-Cachera MF, Thibault H, Souberbielle JC, Soulié D, Carbonel P, Deheeger M, Roinsol D, Longueville E, Bellisle F, Serog P. Massive obesity in adolescents: dietary interventions and behaviours associated with weight regain at 2 y follow-up. Int J Obes Relat Metab Disord. 2004 Apr;28(4):514-9.

ReferenceCitation: Marcellin P, Cadranel JF, Fontanges T, Poynard T, Pol S, Trepo C, Blin P, Bregman B, Schmidely N, Roudot-Thoraval F, Zarski JP. High rate of adefovir-lamivudine combination therapy in nucleoside-naïve patients with chronic hepatitis B in France: results of a national survey in 1730 patients. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1290-6.

ReferenceCitation: Fourrier-Réglat A, Lacoin L, Pariente A, Lassalle R, Robinson P, Droz-Perroteau C, Bégaud B, Blin P, Moore ND. When patients report diseases that prescribers seem unaware of: discordance between patient and physician reporting of risk-related previous history in NSAID users from the CADEUS study. Clin Pharmacol Ther. 2010 Nov;88(5):668-75. doi: 10.1038/clpt.2010.166. Epub 2010 Sep 22.

ReferenceCitation: Blin P, Blazejewski S, Lignot S, Lassalle R, Bernard MA, Jayles D, Théophile H, Bénichou J, Demeaux JL, Ebbo D, Franck J, Moride Y, Peyramond D, Rouveix B, Sturkenboom M, Gehanno P, Droz C, Moore N. Effectiveness of antibiotics for acute sinusitis in real-life medical practice. Br J Clin Pharmacol. 2010 Sep;70(3):418-28. doi: 10.1111/j.1365-2125.2010.03710.x.

ReferenceCitation: Saraux A, Combe B, Blin P, Bregman B, Chartier M, Durieux-Mehlman S, Guillemin F. Survey of the therapeutic management of rheumatoid arthritis in France: the OPALE study. Clin Exp Rheumatol. 2010 May-Jun;28(3):325-32. Epub 2010 Jun 23.

ReferenceCitation: Fourrier-Réglat A, Cuong HM, Lassalle R, Depont F, Robinson P, Droz-Perroteau C, Pariente A, Bégaud B, Blin P, Moore N. Concordance between prescriber- and patient-reported previous medical history and NSAID indication in the CADEUS cohort. Pharmacoepidemiol Drug Saf. 2010 May;19(5):474-81. doi: 10.1002/pds.1951.

ReferenceCitation: Colver AF, Dickinson HO; SPARCLE group. Study protocol: determinants of participation and quality of life of adolescents with cerebral palsy: a longitudinal study (SPARCLE2). BMC Public Health. 2010 May 26;10:280. doi: 10.1186/1471-2458-10-280.

ReferenceCitation: Colver AF, Dickinson HO, Parkinson K, Arnaud C, Beckung E, Fauconnier J, Marcelli M, McManus V, Michelsen SI, Parkes J, Thyen U. Access of children with cerebral palsy to the physical, social and attitudinal environment they need: a cross-sectional European study. Disabil Rehabil. 2011;33(1):28-35. doi: 10.3109/09638288.2010.485669. Epub 2010 May 6.

ReferenceCitation: Fauconnier J, Pasquié JL, Bideaux P, Lacampagne A, Richard S. Cardiomyocytes hypertrophic status after myocardial infarction determines distinct types of arrhythmia: role of the ryanodine receptor. Prog Biophys Mol Biol. 2010 Sep;103(1):71-80. doi: 10.1016/j.pbiomolbio.2010.01.002. Epub 2010 Jan 28. Review.

ReferenceCitation: Fauconnier J, Thireau J, Reiken S, Cassan C, Richard S, Matecki S, Marks AR, Lacampagne A. Leaky RyR2 trigger ventricular arrhythmias in Duchenne muscular dystrophy. Proc Natl Acad Sci U S A. 2010 Jan 26;107(4):1559-64. doi: 10.1073/pnas.0908540107. Epub 2010 Jan 4.

ReferenceCitation: Casez P, Labarère J, Sevestre MA, Haddouche M, Courtois X, Mercier S, Lewandowski E, Fauconnier J, François P, Bosson JL. ICD-10 hospital discharge diagnosis codes were sensitive for identifying pulmonary embolism but not deep vein thrombosis. J Clin Epidemiol. 2010 Jul;63(7):790-7. doi: 10.1016/j.jclinepi.2009.09.002. Epub 2009 Dec 2.

ReferenceCitation: Mansén A, Tiselius C, Sand P, Fauconnier J, Westerblad H, Rydqvist B, Vennström B. Thyroid hormone receptor alpha can control action potential duration in mouse ventricular myocytes through the KCNE1 ion channel subunit. Acta Physiol (Oxf). 2010 Feb;198(2):133-42. doi: 10.1111/j.1748-1716.2009.02052.x. Epub 2009 Oct 14.

ReferenceCitation: Messing B, Man F, Therond P, Hanh T, Thuillier F, Rambaud JC. Selenium status prior to and during one month total parenteral nutrition in gastroenterological patients: A randomised study of two dosages of Se supplementation. Clin Nutr. 1990 Oct;9(5):281-8.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
Cabinet Medical
Cabinet Médical


title: Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®

summary: The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
CHI Creteil
CLCC Nantes
Centre de Forcilles
Institut Gustave Roussy
CHU Pitie Salpetriere


title: ProGene: Etude Genetique et Epidemiologique du Cancer de la Prostate Familial

summary:
The aims of the study are:

to identify genetic and molecular factors (rare mutations, polymorphisms) involved in the natural history of prostate cancers and their response to treatment,
to evaluate and deduce their medical applications for screening and therapeutic management of these tumors.

status: Unknown status

ReferenceCitation: Berthon P, Valeri A, Cohen-Akenine A, Drelon E, Paiss T, Wöhr G, Latil A, Millasseau P, Mellah I, Cohen N, Blanché H, Bellané-Chantelot C, Demenais F, Teillac P, Le Duc A, de Petriconi R, Hautmann R, Chumakov I, Bachner L, Maitland NJ, Lidereau R, Vogel W, Fournier G, Mangin P, Cussenot O, et al. Predisposing gene for early-onset prostate cancer, localized on chromosome 1q42.2-43. Am J Hum Genet. 1998 Jun;62(6):1416-24.

ReferenceCitation: Correa-Cerro L, Wöhr G, Häussler J, Berthon P, Drelon E, Mangin P, Fournier G, Cussenot O, Kraus P, Just W, Paiss T, Cantú JM, Vogel W. (CAG)nCAA and GGN repeats in the human androgen receptor gene are not associated with prostate cancer in a French-German population. Eur J Hum Genet. 1999 Apr;7(3):357-62.

ReferenceCitation: Correa-Cerro L, Berthon P, Häussler J, Bochum S, Drelon E, Mangin P, Fournier G, Paiss T, Cussenot O, Vogel W. Vitamin D receptor polymorphisms as markers in prostate cancer. Hum Genet. 1999 Sep;105(3):281-7.

ReferenceCitation: Valeri A, Fournier G, Morin V, Morin JF, Drelon E, Mangin P, Teillac P, Berthon P, Cussenot O. Early onset and familial predisposition to prostate cancer significantly enhance the probability for breast cancer in first degree relatives. Int J Cancer. 2000 Jun 15;86(6):883-7.

ReferenceCitation: Cancel-Tassin G, Latil A, Valéri A, Mangin P, Fournier G, Berthon P, Cussenot O. PCAP is the major known prostate cancer predisposing locus in families from south and west Europe. Eur J Hum Genet. 2001 Feb;9(2):135-42.

ReferenceCitation: Latil AG, Azzouzi R, Cancel GS, Guillaume EC, Cochan-Priollet B, Berthon PL, Cussenot O. Prostate carcinoma risk and allelic variants of genes involved in androgen biosynthesis and metabolism pathways. Cancer. 2001 Sep 1;92(5):1130-7.

ReferenceCitation: Cormier L, Guillemin F, Valéri A, Fournier G, Cussenot O, Mangin P, Litwin MS. Impact of prostate cancer screening on health-related quality of life in at-risk families. Urology. 2002 Jun;59(6):901-6.

ReferenceCitation: Valeri A, Cormier L, Moineau MP, Cancel-Tassin G, Azzouzi R, Doucet L, Baschet F, Cussenot I, L'Her J, Berthon P, Mangin P, Cussenot O, Morin JF, Fournier G. Targeted screening for prostate cancer in high risk families: early onset is a significant risk factor for disease in first degree relatives. J Urol. 2002 Aug;168(2):483-7.

ReferenceCitation: Azzouzi AR, Cochand-Priollet B, Mangin P, Fournier G, Berthon P, Latil A, Cussenot O. Impact of constitutional genetic variation in androgen/oestrogen-regulating genes on age-related changes in human prostate. Eur J Endocrinol. 2002 Oct;147(4):479-84.

ReferenceCitation: Cancel-Tassin G, Latil A, Rousseau F, Mangin P, Bottius E, Escary JL, Berthon P, Cussenot O. Association study of polymorphisms in the human estrogen receptor alpha gene and prostate cancer risk. Eur Urol. 2003 Oct;44(4):487-90.

ReferenceCitation: Fromont G, Joulin V, Chantrel-Groussard K, Vallancien G, Guillonneau B, Validire P, Latil A, Cussenot O. Allelic losses in localized prostate cancer: association with prognostic factors. J Urol. 2003 Oct;170(4 Pt 1):1394-7.

ReferenceCitation: Latil A, Chêne L, Mangin P, Fournier G, Berthon P, Cussenot O. Extensive analysis of the 13q14 region in human prostate tumors: DNA analysis and quantitative expression of genes lying in the interval of deletion. Prostate. 2003 Sep 15;57(1):39-50.

ReferenceCitation: Valeri A, Briollais L, Azzouzi R, Fournier G, Mangin P, Berthon P, Cussenot O, Demenais F. Segregation analysis of prostate cancer in France: evidence for autosomal dominant inheritance and residual brother-brother dependence. Ann Hum Genet. 2003 Mar;67(Pt 2):125-37.

ReferenceCitation: Roumier X, Azzouzi R, Valéri A, Guillemin F, Fournier G, Cussenot O, Mangin P, Cormier L. Adherence to an annual PSA screening program over 3 years for brothers and sons of men with prostate cancer. Eur Urol. 2004 Mar;45(3):280-5; author reply 285-6.

ReferenceCitation: Thuret R, Chantrel-Groussard K, Azzouzi AR, Villette JM, Guimard S, Teillac P, Berthon P, Houlgatte A, Latil A, Cussenot O. Clinical relevance of genetic instability in prostatic cells obtained by prostatic massage in early prostate cancer. Br J Cancer. 2005 Jan 31;92(2):236-40.

ReferenceCitation: Fromont G, Chene L, Vidaud M, Vallancien G, Mangin P, Fournier G, Validire P, Latil A, Cussenot O. Differential expression of 37 selected genes in hormone-refractory prostate cancer using quantitative taqman real-time RT-PCR. Int J Cancer. 2005 Mar 20;114(2):174-81.

ReferenceCitation: Rouprêt M, Fromont G, Bitker MO, Gattegno B, Vallancien G, Cussenot O. Outcome after radical prostatectomy in young men with or without a family history of prostate cancer. Urology. 2006 May;67(5):1028-32.

ReferenceCitation: Azzouzi AR, Stoppa-Lyonnet D, Roupret M, Larre S, Mangin P, Cussenot O. BRCA2 mutation screening is clinically relevant in breast and early prostate cancer families. Int J Urol. 2007 May;14(5):445-6.

ReferenceCitation: Cussenot O, Azzouzi AR, Nicolaiew N, Mangin P, Cormier L, Fournier G, Valeri A, Cancel-Tassin G. Low-activity V89L variant in SRD5A2 is associated with aggressive prostate cancer risk: an explanation for the adverse effects observed in chemoprevention trials using 5-alpha-reductase inhibitors. Eur Urol. 2007 Oct;52(4):1082-7. Epub 2007 Apr 13.

ReferenceCitation: Yeager M, Orr N, Hayes RB, Jacobs KB, Kraft P, Wacholder S, Minichiello MJ, Fearnhead P, Yu K, Chatterjee N, Wang Z, Welch R, Staats BJ, Calle EE, Feigelson HS, Thun MJ, Rodriguez C, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Giovannucci E, Willett WC, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Gelmann EP, Tucker M, Gerhard DS, Fraumeni JF Jr, Hoover R, Hunter DJ, Chanock SJ, Thomas G. Genome-wide association study of prostate cancer identifies a second risk locus at 8q24. Nat Genet. 2007 May;39(5):645-9. Epub 2007 Apr 1.

ReferenceCitation: Rouprêt M, Hupertan V, Yates DR, Catto JW, Rehman I, Meuth M, Ricci S, Lacave R, Cancel-Tassin G, de la Taille A, Rozet F, Cathelineau X, Vallancien G, Hamdy FC, Cussenot O. Molecular detection of localized prostate cancer using quantitative methylation-specific PCR on urinary cells obtained following prostate massage. Clin Cancer Res. 2007 Mar 15;13(6):1720-5.

ReferenceCitation: Cussenot O, Azzouzi AR, Bantsimba-Malanda G, Gaffory C, Mangin P, Cormier L, Fournier G, Valeri A, Jouffe L, Roupret M, Fromont G, Sibony M, Comperat E, Cancel-Tassin G. Effect of genetic variability within 8q24 on aggressiveness patterns at diagnosis and familial status of prostate cancer. Clin Cancer Res. 2008 Sep 1;14(17):5635-9. doi: 10.1158/1078-0432.CCR-07-4999.

family: Cussenot

full_name: Olivier Cussenot

given: Olivier

family: Azzouzi

full_name: Abdel-Rahmène Azzouzi

given: Abdel-Rahmène

family: Bantsimba-Malanda

full_name: Gladys Bantsimba-Malanda

given: Gladys

family: Gaffory

full_name: Cecile Gaffory

given: Cecile

family: Mangin

full_name: Philippe Mangin

family: Cormier

full_name: Luc Cormier

family: Fournier

full_name: Georges Fournier

given: Georges

family: Valeri

full_name: Antoine Valeri

given: Antoine

family: Jouffe

full_name: Lionel Jouffe

given: Lionel

family: Roupret

full_name: Morgan Roupret

given: Morgan

family: Fromont

full_name: Gaelle Fromont

given: Gaelle

family: Sibony

full_name: Mathilde Sibony

given: Mathilde

family: Comperat

full_name: Eva Comperat

given: Eva

family: Cancel-Tassin

full_name: Géraldine Cancel-Tassin

given: Géraldine

journal_name: Clinical Cancer Research

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Association for Cancer Research (AACR)

title: Effect of Genetic Variability within 8q24 on Aggressiveness Patterns at Diagnosis and Familial Status of Prostate Cancer

ReferenceCitation: Ahn J, Berndt SI, Wacholder S, Kraft P, Kibel AS, Yeager M, Albanes D, Giovannucci E, Stampfer MJ, Virtamo J, Thun MJ, Feigelson HS, Cancel-Tassin G, Cussenot O, Thomas G, Hunter DJ, Fraumeni JF Jr, Hoover RN, Chanock SJ, Hayes RB. Variation in KLK genes, prostate-specific antigen and risk of prostate cancer. Nat Genet. 2008 Sep;40(9):1032-4; author reply 1035-6. doi: 10.1038/ng0908-1032.

family: Ahn

full_name: Jiyoung Ahn

given: Jiyoung

family: Berndt

full_name: Sonja I Berndt

ReferenceCitation: Fromont G, Yacoub M, Valeri A, Mangin P, Vallancien G, Cancel-Tassin G, Cussenot O. Differential expression of genes related to androgen and estrogen metabolism in hereditary versus sporadic prostate cancer. Cancer Epidemiol Biomarkers Prev. 2008 Jun;17(6):1505-9. doi: 10.1158/1055-9965.EPI-07-2778.

journal_name: Cancer Epidemiology Biomarkers & Prevention

title: Differential Expression of Genes Related to Androgen and Estrogen Metabolism in Hereditary versus Sporadic Prostate Cancer

ReferenceCitation: Thomas G, Jacobs KB, Yeager M, Kraft P, Wacholder S, Orr N, Yu K, Chatterjee N, Welch R, Hutchinson A, Crenshaw A, Cancel-Tassin G, Staats BJ, Wang Z, Gonzalez-Bosquet J, Fang J, Deng X, Berndt SI, Calle EE, Feigelson HS, Thun MJ, Rodriguez C, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Giovannucci E, Willett WC, Cussenot O, Valeri A, Andriole GL, Crawford ED, Tucker M, Gerhard DS, Fraumeni JF Jr, Hoover R, Hayes RB, Hunter DJ, Chanock SJ. Multiple loci identified in a genome-wide association study of prostate cancer. Nat Genet. 2008 Mar;40(3):310-5. doi: 10.1038/ng.91. Epub 2008 Feb 10.

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

repository_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Lou H, Yeager M, Li H, Bosquet JG, Hayes RB, Orr N, Yu K, Hutchinson A, Jacobs KB, Kraft P, Wacholder S, Chatterjee N, Feigelson HS, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Ma J, Gaziano JM, Stampfer M, Schumacher FR, Giovannucci E, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Crawford ED, Anderson SK, Tucker M, Hoover RN, Fraumeni JF Jr, Thomas G, Hunter DJ, Dean M, Chanock SJ. Fine mapping and functional analysis of a common variant in MSMB on chromosome 10q11.2 associated with prostate cancer susceptibility. Proc Natl Acad Sci U S A. 2009 May 12;106(19):7933-8. doi: 10.1073/pnas.0902104106. Epub 2009 Apr 21.

journal_name: Proceedings of the National Academy of Sciences

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: Nicolaiew N, Cancel-Tassin G, Azzouzi AR, Grand BL, Mangin P, Cormier L, Fournier G, Giordanella JP, Pouchard M, Escary JL, Valeri A, Cussenot O. Association between estrogen and androgen receptor genes and prostate cancer risk. Eur J Endocrinol. 2009 Jan;160(1):101-6. doi: 10.1530/EJE-08-0321. Epub 2008 Oct 24.

ReferenceCitation: Yeager M, Chatterjee N, Ciampa J, Jacobs KB, Gonzalez-Bosquet J, Hayes RB, Kraft P, Wacholder S, Orr N, Berndt S, Yu K, Hutchinson A, Wang Z, Amundadottir L, Feigelson HS, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Crawford ED, Haiman CA, Henderson B, Kolonel L, Le Marchand L, Siddiq A, Riboli E, Key TJ, Kaaks R, Isaacs W, Isaacs S, Wiley KE, Gronberg H, Wiklund F, Stattin P, Xu J, Zheng SL, Sun J, Vatten LJ, Hveem K, Kumle M, Tucker M, Gerhard DS, Hoover RN, Fraumeni JF Jr, Hunter DJ, Thomas G, Chanock SJ. Identification of a new prostate cancer susceptibility locus on chromosome 8q24. Nat Genet. 2009 Oct;41(10):1055-7. doi: 10.1038/ng.444. Epub 2009 Sep 20.

ReferenceCitation: Prokunina-Olsson L, Fu YP, Tang W, Jacobs KB, Hayes RB, Kraft P, Berndt SI, Wacholder S, Yu K, Hutchinson A, Spencer Feigelson H, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Crawford ED, Haiman CA, Henderson BE, Kolonel L, Le Marchand L, Siddiq A, Riboli E, Travis R, Kaaks R, Isaacs WB, Isaacs SD, Grönberg H, Wiklund F, Xu J, Vatten LJ, Hveem K, Kumle M, Tucker M, Hoover RN, Fraumeni JF Jr, Hunter DJ, Thomas G, Chatterjee N, Chanock SJ, Yeager M. Refining the prostate cancer genetic association within the JAZF1 gene on chromosome 7p15.2. Cancer Epidemiol Biomarkers Prev. 2010 May;19(5):1349-55. doi: 10.1158/1055-9965.EPI-09-1181. Epub 2010 Apr 20.

title: Refining the Prostate Cancer Genetic Association within the JAZF1 Gene on Chromosome 7p15.2

ReferenceCitation: Cussenot O, Azzouzi AR, Nicolaiew N, Fromont G, Mangin P, Cormier L, Fournier G, Valeri A, Larre S, Thibault F, Giordanella JP, Pouchard M, Zheng Y, Hamdy FC, Cox A, Cancel-Tassin G. Combination of polymorphisms from genes related to estrogen metabolism and risk of prostate cancers: the hidden face of estrogens. J Clin Oncol. 2007 Aug 20;25(24):3596-602.

lead_sponsor: Centre de Recherche sur les Pathologies Prostatiques

location_facility: Department of Urology, Hopital Pitié-Salpetriere

location_facility: Department of Urology, Hopital de la Cavale Blanche


title: Evaluation of IL-6 and IL-8 Interleukin Rates to Diagnose Spontaneous Bacterial Peritonitis

summary:
Spontaneous bacterial peritonitis (SBP), an infection of ascitic fluid in the absence of localized intra-abdominal infection, is one of the main potentially fatal complications of cirrhosis. In the case of SBP, early diagnosis and rapid therapeutic care can improve patient survival (Garcia-Tsao, 2001).

The diagnosis of SBP is based on the detection of a polymorphonuclear neutrophils count equal to or greater than 250 /mm3 in the ascitic fluid (method of reference). However, obtaining an ascitic cell count is sometimes difficult because it can not always be performed in emergency especially outside the opening hours of the laboratory of Bacteriology. This raises the necessity of developing quick and easy alternative approaches of diagnosis.

Few groups have proposed the use of urinary reagent strip for rapid diagnosis of SBP. Nevertheless, the investigators clinical teams have shown that the sensitivity of this test was low in a large national multicenter prospective study involving more than a thousand patients (Nousbaum et al., 2007). The use of Multistix strips test is thus not recommended for the routine application of diagnosis of SBP due to its lack of sensitivity.

Although performed on small groups of patients, several studies have reported that IL-8 or IL-6 might be used as markers of ascitic fluid infections. Based on these data and confirmed by the investigators preliminary results the investigators propose to study on a broad recruitment of patients estimated to about 500 inclusions (about 45 infected patients) the interest of using IL-8 and IL-6 as predictive markers of SBP. The investigators propose to use an ELISA method, standardized, rapid and automated, applicable in the context of emergency (7 days a week and 24 hours a day) as previously described in the work conducted to exclude the urinary tract infection (Oregioni et al., 2005).

During the preliminary experiments conducted for this project, the investigators also found systematic variation of another marker, leptin. This is a protein hormone involved in the inflammatory and immune responses (Otero et al., 2005). It appears necessary to include the study of this marker in the analysis of differential protein response between patients suffering or not suffering from SBP.

The investigators therefore propose a diagnostic study, non-interventional, prospective, multicenter trial conducted over 2 years.

The main objective is to establish the diagnostic performance (sensitivity, specificity, positive predictive value and negative) of IL-8 and IL-6, assayed in the ascites fluid by an automated ELISA in the early diagnosis of SBP.
The secondary objectives are to confirm the interest of the measurement of leptin in the SBP and to establish the diagnostic performance of IL-8 and IL-6 or leptin according to different clinical features in patients (score Child-Pugh classification and history of SBP, ascitic fluid infection with positive bacterial culture).

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hepato-gastro-enterology and bacteriology department

location_facility: Hepato-gastro-enterology and Bacteriology department


title: An Open Label Dose Escalation and Pharmacokinetic Phase I Study With Pazopanib in Combination With Cisplatin (CDDP) Every Three Weeks in Patients With Advanced Solid Tumors

acronym: PACIFIK

summary:
The aim of this research is to evaluate the potential interest of an association of Pazopanib, a multi-tyrosine kinase inhibitor, and cisplatin.

As cisplatin has marketing approval for several cancers (ovarian, testicle, bladder, esophagus, endometrium, lung, stomach, head and neck cancer (HNC)), and in order to have a rapid evaluation of this combination, we will evaluate the combination in any patient whose tumors is known to be sensible to cisplatin (except tumors at risk of bleeding).

This study is a classical phase 1 trial of pazopanib and 3-weekly cisplatin association. It will allow for optimal dose selection and pharmacokinetic analysis. It is planed to include around 38 patients, enriching the optimal tolerated regimen (OTR) level only with a cohort of triple negative breast cancer patients. If the association is proven to be feasible, we will then move to a specific phase II study in triple negative breast cancer patients.

ReferenceCitation: Diéras V, Bachelot T, Campone M, Isambert N, Joly F, Le Tourneau C, Cassier P, Bompas E, Fumoleau P, Noal S, Orsini C, Jimenez M, Imbs DC, Chatelut E. A Phase I, Dose-Escalation Trial of Pazopanib in Combination with Cisplatin in Patients with Advanced Solid Tumors: A UNICANCER Study. Oncol Ther. 2016;4(2):211-223. doi: 10.1007/s40487-016-0027-x. Epub 2016 Aug 18.

family: Diéras

full_name: Véronique Diéras

given: Véronique

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Campone

full_name: Mario Campone

given: Mario

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Joly

full_name: Florence Joly

given: Florence

family: Le Tourneau

full_name: Christophe Le Tourneau

given: Christophe

family: Cassier

full_name: Philippe Cassier

given: Philippe

family: Bompas

full_name: Emmanuelle Bompas

given: Emmanuelle

family: Fumoleau

full_name: Pierre Fumoleau

given: Pierre

family: Noal

full_name: Sabine Noal

given: Sabine

family: Orsini

full_name: Christine Orsini

given: Christine

family: Jimenez

full_name: Marta Jimenez

given: Marta

family: Imbs

full_name: Diane Charlotte Imbs

given: Diane Charlotte

family: Chatelut

full_name: Etienne Chatelut

given: Etienne

journal_name: Oncology and Therapy

license: implied-oa

license_normalized: implied-oa

location_facility:
Centre Léon Berard
Centre Georges François LECLERC
Institut Curie
Centre René Gauducheau
Centre François BACLESSE


ReferenceCitation: Dupeyron A, Dénarié M, Richard D, Dobija L, Castelli C, Petiot S, Tavares I, Gelis A, Coudeyre E. Analgesic gas for rehabilitation of frozen shoulder: Protocol for a randomized controlled trial. Ann Phys Rehabil Med. 2019 Jan;62(1):43-48. doi: 10.1016/j.rehab.2018.07.007. Epub 2018 Aug 9.

family: Dupeyron

full_name: Arnaud Dupeyron

given: Arnaud

family: Dénarié

full_name: Marie Dénarié

given: Marie

family: Richard

full_name: Dominique Richard

given: Dominique

family: Dobija

full_name: Lech Dobija

given: Lech

family: Castelli

full_name: Christel Castelli

given: Christel

family: Petiot

full_name: Sylvie Petiot

given: Sylvie

family: Tavares

full_name: Isabelle Tavares

given: Isabelle

family: Gelis

full_name: Anthony Gelis

given: Anthony

family: Coudeyre

full_name: Emmanuel Coudeyre

given: Emmanuel

journal_name: Annals of Physical and Rehabilitation Medicine

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

acronym: MEOPA

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Unité Rééducation Réadaptation Locomotrice

title: Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis

summary: The purpose of this study is to determine whether or not the use of an equimolar mixture of oxygen and nitrous oxide during the physical therapy for patients suffering from frozen shoulder (adhesive shoulder capsulitis) results in a gain in shoulder amplitude (Constant Score) and less pain as compared to patients undergoing physical therapy without this treatment.


title: A Phase I/II Multicenter Study of IV Clofarabine in Patients With High-Risk Myelodysplastic Syndrome Who Have Failed Therapy With Azacitidine: the NIDEVOL Study

summary: This study aims to determine the maximal tolerated dose (MTD) and dose limiting toxicities (DLTs) of low dose IV clofarabine for MDS patients after treatment failure of azacitidine.

design_allocation: Non-Randomized

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
Institut Paoli-Calmettes
Hopital Cochin Service d'Hématologie
Hôpital Avicenne
Centre Henri Becquerel
Hôpital Saint-Louis


title: Post Authorization Safety Study of the Intramuscular Inactivated, Split Virion Pandemic A/H1N1 Influenza Vaccines in Children Aged Over 2 Months and in Adult Populations

summary:
This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.

Primary objective:

To describe the incidence of serious adverse events and adverse events of special interest (AESIs) after HUMENZA or PANENZA administration throughout the study in different age groups.

Secondary objective:

To describe the incidence of non-serious cutaneous allergic reactions after HUMENZA or PANENZA administration in different age groups up to 21 days after the last vaccination.This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.

lead_sponsor: Sanofi Pasteur, a Sanofi Company


intervention_type: Radiation

acronym: RACCOSA

location_facility: Département de Pathologie Respiratoire du CHU de Limoges

title: Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC

summary: The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients.


title: A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

summary:
The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).

Primary Objectives:

Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination.

Safety: To follow-up the long-term safety up to 5 years post-vaccination.

lead_sponsor: Sanofi


title: SORAFENIB (NEXAVAR®) in Combination With Irinotecan in the Second Line Treatment or More of Metastatic Colorectal Cancer With K-RAS Mutation : a Multicentre Two-part Phase I/II Study.

acronym: NEXIRI

summary: A multicentre two-part phase I/II study evaluating response and safety of SORAFENIB in combination with irinotecan in the second line treatment or more of metastatic colorectal cancer with K-RAS mutation.

ReferenceCitation: Samalin E, Bouché O, Thézenas S, Francois E, Adenis A, Bennouna J, Taieb J, Desseigne F, Seitz JF, Conroy T, Galais MP, Assenat E, Crapez E, Poujol S, Bibeau F, Boissière F, Laurent-Puig P, Ychou M, Mazard T. Sorafenib and irinotecan (NEXIRI) as second- or later-line treatment for patients with metastatic colorectal cancer and KRAS-mutated tumours: a multicentre Phase I/II trial. Br J Cancer. 2014 Mar 4;110(5):1148-54. doi: 10.1038/bjc.2013.813. Epub 2014 Jan 9.

family: Samalin

full_name: E Samalin

given: E

family: Bouché

full_name: O Bouché

given: O

family: Thézenas

full_name: S Thézenas

given: S

family: Francois

full_name: E Francois

family: Adenis

full_name: A Adenis

given: A

family: Bennouna

full_name: J Bennouna

given: J

family: Taieb

full_name: J Taieb

family: Desseigne

full_name: F Desseigne

given: F

family: Seitz

full_name: J F Seitz

given: J F

family: Conroy

full_name: T Conroy

given: T

family: Galais

full_name: M P Galais

given: M P

family: Assenat

full_name: E Assenat

family: Crapez

full_name: E Crapez

family: Poujol

full_name: S Poujol

family: Bibeau

full_name: F Bibeau

family: Boissière

full_name: F Boissière

family: Laurent-Puig

full_name: P Laurent-Puig

given: P

family: Ychou

full_name: M Ychou

given: M

family: Mazard

full_name: T Mazard

journal_name: British Journal of Cancer

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility:
CHU Robert Debre
Centre Antoine Lacassagne
Centre Oscar Lambret
Hopital Saint Eloi
Centre Rene Gauducheau


ReferenceCitation: Duval X, Caplanusi A, Laurichesse H, Deplanque D, Loulergue P, Vaman T, Launay O, Gillard P. Flexibility of interval between vaccinations with AS03A-adjuvanted influenza A (H1N1) 2009 vaccine in adults aged 18-60 and >60 years: a randomized trial. BMC Infect Dis. 2012 Jul 23;12:162. doi: 10.1186/1471-2334-12-162.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

acronym: FLU D-PAN H1N1-022

ipd_sharing: Yes

title: Safety and Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2340272A in Adults Aged 18 Years and Above

summary: The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.


title: Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)

summary:
Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of cutaneous bullous lesion arising spontaneously or after mechanical trauma.

These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no treatment available. Cares are consisting to dress lesions and to protect the skin.

The investigators have recently observed on patients having residual expression of collagen VII that phenotype severity is modulated by activation degree of dermic metalloproteinase. The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be regulated this activity.

The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease the number of cutaneous bullosa after four month of treatment.

The primary outcome measure is the rate of patient presenting a decrease of 20% or more of the number of cutaneous bullosa.

Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the average duration of cicatrisation and treatment tolerance.

This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.

When patients are included, they will be randomized and receive the treatment (or placebo) for 4 months.

ReferenceCitation: Chiaverini C, Roger C, Fontas E, Bourrat E, Bourdon-Lanoy E, Labrèze C, Mazereeuw J, Vabres P, Bodemer C, Lacour JP. Oral epigallocatechin-3-gallate for treatment of dystrophic epidermolysis bullosa: a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial. Orphanet J Rare Dis. 2016 Mar 25;11:31. doi: 10.1186/s13023-016-0411-5.

family: Chiaverini

full_name: Christine Chiaverini

given: Christine

family: Roger

full_name: Coralie Roger

given: Coralie

family: Fontas

full_name: Eric Fontas

given: Eric

family: Bourrat

full_name: Emmanuelle Bourrat

given: Emmanuelle

family: Bourdon-Lanoy

full_name: Eva Bourdon-Lanoy

given: Eva

family: Labrèze

full_name: Christine Labrèze

family: Mazereeuw

full_name: Juliette Mazereeuw

given: Juliette

family: Vabres

full_name: Pierre Vabres

given: Pierre

family: Bodemer

full_name: Christine Bodemer

family: Lacour

full_name: Jean-Philippe Lacour

given: Jean-Philippe

journal_name: Orphanet Journal of Rare Diseases

location_facility: Dermatology Department, Bordeaux University Hospital

location_facility: Dermatology Department, Saint Louis Hospital, APHP

location_facility: Dermatology Department, Necker Enfants Malades, APHP

location_facility: Dijon University Hospital, Dermatology Department

location_facility: Toulouse University Hospital, Dermatology Department


title: Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing

acronym: SEPTAL-PM

summary: The SEPTAL-PM study is aimed to compare the right ventricular apical and right ventricular septal position of the right ventricular lead in patients implanted with a pacemaker for conventional anti-bradycardia pacing indications requiring permanent right ventricular pacing ; the primary endpoint is the evolution of the left ventricular ejection fraction assessed by contrast echocardiography at 18-months follow-up.

lead_sponsor: Rennes University Hospital

location_facility:
CHU d'Angers
Service de cardiologie-CHU de Nantes
CHU de Poitiers
CHU de Rennes
Service de cardiologie-CHU de Brest


title: Evaluation of Hemodynamic Effects of Cascade Hemofiltration in Septic Shock

acronym: Cascade

summary:
Septic shock is a major cause of mortality and morbidity in critically ill patients. Septic Shock is associated with an overwhelming, systemic overflow of pro inflammatory and anti-inflammatory mediators, which leads to generalized endothelial damage, multiple organ failure, and altered cellular immunological responsiveness. Although our understanding of the complex pathophysiological alterations that occur in septic shock has increased greatly as a result of recent clinical and preclinical studies, mortality associated with the disorder remains unacceptably high, ranging from 30% to 50%. To date, attempts to improve survival with innovative, predominantly anti-inflammatory therapeutic strategies have been disappointing. A standard hemofiltration rate of 35 ml/kg/hour has been successfully used to treat acute renal failure. However, this dose does not alter plasma levels of inflammatory mediators, suggesting that its ability to clear these mediators is suboptimal. Higher doses of hemofiltration (up to 120 ml/kg per hour) have been demonstrated to improve cardiac function and hemodynamics in several animal models of sepsis. High-volume hemofiltration (HVHF) was thus conceived and applied in patients with septic shock, showing an improvements in hemodynamics with decreased vasopressor requirements and improved survival in patients admitted after a cardiac arrest.

The main benefit described with high volume hemofiltration is a hemodynamic improvement (e.g reduction in catecholamines' requirement). This improvement seems to be due to the removal of a badly defined network of middle molecular weight peptides. To remove efficiently these middle molecular peptides, a high filtration rate is needed. However, with high filtration rates, there is also a high clearance for smaller molecules, including antibiotics, electrolytes, vitamins, trace elements and amino acids.

The cascade hemofiltration system has been designed for a more efficient removal of middle molecular weight peptides with a limited solute consumption.

The goal of this study is the evaluation of the hemodynamic improvement using cascade hemofiltration in patients treated for septic shock.

lead_sponsor: Baxter Healthcare Corporation

location_facility:
Hopital Delafontaine
Hopital Le Bocage
Centre Hospitalier Marc JACQUET
Hopital Tenon
CHU hospital


title: Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy

acronym: SPAM

summary: The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Oscar Lambret
Intercommunal Hospital
Geroges PIANTA Hospital
Centre Henri Becquerel
Hopital Saint Vincent


lead_sponsor: Lymphoma Study Association

location_facility:
CHRU Lille
CHU de Dijon
CHU Brabois
Centre Henri Becquerel
CHU Lyon Sud

title: A Phase IB Study of Escalating Doses of REVLIMID in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma

summary: The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone).


title: A Multicenter Prospective Randomized Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation

summary:
This study is a prospective comparison between 2 popular regimens based on reduced intensity or non-myeloablative approaches to define the optimal myeloablative and/or immu-nonsuppressive association for reduced intensity conditionings (RIC).

Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2 days) and Thymoglobuline (2.5 mg/m²/1day).

Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation (TBI).

A randomization of 2 phase study according to the methodology developed by Liu et al (Liu, 1993 and 2001) for the evaluation of multiple innovative approaches.

Primary endpoint is one year overall survival (OS). Stopping rules included excessive engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an independent safety review board (ISRB).

Inclusion criteria are patients presenting a hematological malignancy, eligible for non myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable HLA identical sibling. All patients and donors are included after giving written informed consent.

Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular therapies committee (national agency).

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Institut Paoli-Calmettes
CHU


title: Non-comparative, Opened Study, Evaluating in HIV-1 Infected Patients With Undetectable Viral Load, Treated by an Antiretroviral Combination Including a Protease Inhibitor Boosted With Ritonavir and Administered by Oral Route Twice a Day, the Substitutability of the Current Protease Inhibitor Regimen by the Association Darunavir/Ritonavir 800/100 mg Once a Day to Maintain the Viral Load Under the 50 Copies/ml Limit of Detection After 24 Weeks of Treatment.

acronym: RADAR

summary:
Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain.

Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

location_facility: Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne

location_facility: Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales

location_facility: Hôpital Tenon - Service des Maladies Infectieuses et Tropicales


title: Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study

acronym: POST

summary: We performed a national cross-sectional and prospective large epidemiological cohort study in patients with ST. Office- and hospital-based vascular medicine French practitioners enrolled all consecutive patients with a symptomatic ST of the lower limbs at least 5 cm long documented by compression ultrasonography. Follow-up was three months. All events were adjudicated by a central committee.

time_perspective: Cross-Sectional

ReferenceCitation: Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.

family: GALANAUD

full_name: J. P. GALANAUD

given: J. P.

family: BOSSON

full_name: J. L. BOSSON

given: J. L.

family: GENTY

full_name: C. GENTY

given: C.

family: PRESLES

full_name: E. PRESLES

given: E.

family: CUCHERAT

full_name: M. CUCHERAT

given: M.

family: SEVESTRE

full_name: M. A. SEVESTRE

given: M. A.

family: QUERE

full_name: I. QUERE

given: I.

family: DECOUSUS

full_name: H. DECOUSUS

given: H.

family: LEIZOROVICZ

full_name: A. LEIZOROVICZ

given: A.

journal_name: Journal of Thrombosis and Haemostasis

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Decousus H, Quéré I, Presles E, Becker F, Barrellier MT, Chanut M, Gillet JL, Guenneguez H, Leandri C, Mismetti P, Pichot O, Leizorovicz A; POST (Prospective Observational Superficial Thrombophlebitis) Study Group. Superficial venous thrombosis and venous thromboembolism: a large, prospective epidemiologic study. Ann Intern Med. 2010 Feb 16;152(4):218-24. doi: 10.7326/0003-4819-152-4-201002160-00006.

family: Decousus

full_name: Hervé Decousus

given: Hervé

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

title: Superficial Venous Thrombosis and Venous Thromboembolism

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Guenneguez LEANDRI Barrelier CHANUT GILLET


ReferenceCitation: Gunzer K, Joly F, Ferrero JM, Gligorov J, de Mont-Serrat H, Uttenreuther-Fischer M, Pelling K, Wind S, Bousquet G, Misset JL. A phase II study of afatinib, an irreversible ErbB family blocker, added to letrozole in patients with estrogen receptor-positive hormone-refractory metastatic breast cancer progressing on letrozole. Springerplus. 2016 Jan 19;5:45. doi: 10.1186/s40064-015-1601-7. eCollection 2016.

family: Gunzer

full_name: Katharina Gunzer

given: Katharina

family: Joly

full_name: Florence Joly

given: Florence

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Gligorov

full_name: Joseph Gligorov

given: Joseph

family: de Mont-Serrat

full_name: Helene de Mont-Serrat

given: Helene

family: Uttenreuther-Fischer

full_name: Martina Uttenreuther-Fischer

given: Martina

family: Pelling

full_name: Katy Pelling

given: Katy

family: Wind

full_name: Sven Wind

given: Sven

family: Bousquet

full_name: Guilhem Bousquet

given: Guilhem

family: Misset

full_name: Jean-Louis Misset

given: Jean-Louis

journal_name: SpringerPlus

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

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

repositories:
HAL
PubMed Central

lead_sponsor: Boehringer Ingelheim

location_facility: 1200.5.3301A Boehringer Ingelheim Investigational Site

location_facility: 1200.5.3305A Boehringer Ingelheim Investigational Site

location_facility: 1200.5.3304A Boehringer Ingelheim Investigational Site

location_facility: 1200.5.3306A Boehringer Ingelheim Investigational Site

location_facility: 1200.5.3302A Boehringer Ingelheim Investigational Site

title: A Phase II Study of BIBW 2992 Administration in Patients With Hormone Refractory Metastatic Breast Cancer

summary: Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole


title: Evaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK.

acronym: AMANDYSK

summary:
This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 7 centers and 80 patients of both sexes.

The primary objective of the trial is to evaluate the effects of the interruption of a long term treatment (ex. Greater than 6 months) with Amantadine (prescribed as an antidyskinetic) in patients suffering from Parkinson disease being treated with Levodopa and suffering from mid dose dyskinesias.

Secondary objectives of the trial are the evaluation of the other effects of withdrawal of Amantadine on the same group of patients: motor fluctuations, vigilance, apathy, fatigue, certain cognitive aspects, the disappearance or development of undesirable side effects and quality of life.

ReferenceCitation: Alves G, Wentzel-Larsen T, Larsen JP. Is fatigue an independent and persistent symptom in patients with Parkinson disease? Neurology. 2004 Nov 23;63(10):1908-11.

ReferenceCitation: Bibbiani F, Oh JD, Kielaite A, Collins MA, Smith C, Chase TN. Combined blockade of AMPA and NMDA glutamate receptors reduces levodopa-induced motor complications in animal models of PD. Exp Neurol. 2005 Dec;196(2):422-9. Epub 2005 Oct 3.

ReferenceCitation: Chapuis S, Ouchchane L, Metz O, Gerbaud L, Durif F. Impact of the motor complications of Parkinson's disease on the quality of life. Mov Disord. 2005 Feb;20(2):224-30.

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU de Clermont-Ferrand
Hôpital d'Aix en Provence
CHU Pitié-Salpêtrière
CHU Timone
Hôpital Haut-Lévêque


title: Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux

summary: The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
Centre hospitalier de Bretagne Sud
Centre Guillaume Le Conquerant
Centre Jean Perrin
Centre hospitalier Annecy
Institut Gustave Roussy


type: Other Grant/Funding Number

title: Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients

acronym: RenforcHémi

summary: Gait impairment remain one of the main problem for hemiplegic stroke patients. After the 6 first months, stroke patients are classically described with moderate or no improvement. Here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular strengthening program with conventional physiotherapy delivered by the local physiotherapist of the patient, in a very ecological way.

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital de Salies du Salat

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital Pellegrin, CHU de Bordeaux,

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital Jean Rebeyrol, CHU de Limoges,

location_facility: Centre Mutualiste de Rééducation Fonctionnelle, rue Angély Cavlié

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, CHU de Toulouse, TSA 50032


title: Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients

summary: Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .

lead_sponsor: Nestlé

location_facility: Hopital Saint Antoine- Service des Brules

intervention_type: Dietary Supplement


title: Prediction of the Response to Chemotherapy by Tomoscintigraphie the MIBI in the Balance Sheet Pre Hodgkin's Disease and Lymphoma Malins High Grade

acronym: MIBI

summary:
Predicting response to chemotherapy in patients with Hodgkin's disease or lymphoma high-grade malignant de novo or recurrence.

The non-Hodgkin's lymphoma and high-grade Hodgkin's disease may show resistance to chemotherapy, regardless of their initial extension. The failure of treatment is most often correlated with an incomplete answer or lack of response to chemotherapy as a result chemoresistance. This drug, which may involve the gene MDR1 (multidrug resistance) encoding the protein PGP, can be studied in vivo by MIBI scan. The MIBI is behind a tracer perfusionnel used routinely to explore myocardial perfusion, but it has other characteristics of fixing, which can be used in oncological imaging (fixation by glial tumors of high grade).Prospective Study, which includes conducting a tomoscintigraphie 30 minutes after injection of 20 mCi of 99mTc-MIBI in initial stock or relapse of high-grade lymphoma and Hodgkin's disease any stage (I-IV). Fixing the MIBI is compared with morphological abnormalities detected by CT and the setting of lesions by 18FDG. Patients will be treated in a traditional way, without changes in treatment protocols used in routine. Patients with a negative MIBI scan, will be watched with particular attention in order to detect insufficient response to chemotherapy. The only change, the care of patients, only for the achievement of an initial consideration of non-invasive imaging, further, which is the tomoscintigraphie the MIBI. Of the tumor samples, will be evaluated by immunohistochemistry, the expression of PGP and the MRP1 (two proteins associated with the drug). On blood, may be carried out genotyping of MDR1, MRP1 and MRP2 to the patient.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Limoges

location_facility:
Anatomo-pathology
Nuclear Medicine
Hematology
Radiology
Pharmacology


title: Phase I Study Evaluating the Combination of Lapatinib + Vinorelbine in Patients With Locally Advanced or Metastatic Breast Cancer Overexpressing HER2

summary:
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast cancer.

lead_sponsor: UNICANCER

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc


title: Efficacy Study of Oral Glutamine Supplementation in Duchenne Muscular Dystrophy

acronym: MDB-GLN

summary: The purpose of this study is to determine whether long-term oral glutamine supplementation is effective in improving muscle mass and function in children with Duchenne muscular dystrophy (DMD).

ReferenceCitation: Mok E, Eléouet-Da Violante C, Daubrosse C, Gottrand F, Rigal O, Fontan JE, Cuisset JM, Guilhot J, Hankard R. Oral glutamine and amino acid supplementation inhibit whole-body protein degradation in children with Duchenne muscular dystrophy. Am J Clin Nutr. 2006 Apr;83(4):823-8.

ReferenceCitation: Hankard R, Mauras N, Hammond D, Haymond M, Darmaun D. Is glutamine a 'conditionally essential' amino acid in Duchenne muscular dystrophy? Clin Nutr. 1999 Dec;18(6):365-9.

ReferenceCitation: Hankard RG, Hammond D, Haymond MW, Darmaun D. Oral glutamine slows down whole body protein breakdown in Duchenne muscular dystrophy. Pediatr Res. 1998 Feb;43(2):222-6.

ReferenceCitation: Hankard RG, Haymond MW, Darmaun D. Effect of glutamine on leucine metabolism in humans. Am J Physiol. 1996 Oct;271(4 Pt 1):E748-54.

ReferenceCitation: Hankard RG, Darmaun D, Sager BK, D'Amore D, Parsons WR, Haymond M. Response of glutamine metabolism to exogenous glutamine in humans. Am J Physiol. 1995 Oct;269(4 Pt 1):E663-70.

ReferenceCitation: Mok E, Béghin L, Gachon P, Daubrosse C, Fontan JE, Cuisset JM, Gottrand F, Hankard R. Estimating body composition in children with Duchenne muscular dystrophy: comparison of bioelectrical impedance analysis and skinfold-thickness measurement. Am J Clin Nutr. 2006 Jan;83(1):65-9.

ReferenceCitation: Mok E, Letellier G, Cuisset JM, Denjean A, Gottrand F, Alberti C, Hankard R. Lack of functional benefit with glutamine versus placebo in Duchenne muscular dystrophy: a randomized crossover trial. PLoS One. 2009;4(5):e5448. doi: 10.1371/journal.pone.0005448. Epub 2009 May 6.

family: Mok

full_name: Elise Mok

given: Elise

family: Letellier

full_name: Guy Letellier

given: Guy

family: Cuisset

full_name: Jean-Marie Cuisset

given: Jean-Marie

family: Denjean

full_name: André Denjean

given: André

family: Gottrand

full_name: Frédéric Gottrand

given: Frédéric

family: Alberti

full_name: Corinne Alberti

given: Corinne

family: Hankard

full_name: Régis Hankard

given: Régis

title: Lack of Functional Benefit with Glutamine versus Placebo in Duchenne Muscular Dystrophy: A Randomized Crossover Trial

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'Investigation Clinique (CIC9202), Hôpital Robert Debré, Assistance Publique-Hôpitaux de Paris

location_facility: Centre d'Investigation Clinique, Hôpital Cardiologique, CHR&U de Lille

location_facility: Service de Neuropédiatrie, Hôpital Roger Salengro, CHR&U de Lille

location_facility: Pédiatrie Multidisciplinaire et Nutrition de l'Enfant, Centre Hospitalier Universitaire de Poitiers

location_facility: Service d'Hépato Gastro Entérologie, Hôpital Jeanne de Flandre, CHR&U de Lille


title: Multicenter Phase 2 Study of Efficacy and Safety of Pegylated Interferon-alfa 2a in Polycythemia Vera Patients

summary: Interferon alfa is an effective treatment of polycythemia vera (PV), but about 20% of patients discontinue their treatment because of side effects and treatment schedule (three times per week administration). The pegylated form of interferon alfa-2a has shown a better tolerance in hepatitis patients and is administered only once a week. The purpose of this study is to determine efficacy and safety of pegylated interferon alfa-2a in the treatment of PV patients.

ReferenceCitation: Berk PD, Goldberg JD, Donovan PB, Fruchtman SM, Berlin NI, Wasserman LR. Therapeutic recommendations in polycythemia vera based on Polycythemia Vera Study Group protocols. Semin Hematol. 1986 Apr;23(2):132-43.

ReferenceCitation: Fruchtman SM, Mack K, Kaplan ME, Peterson P, Berk PD, Wasserman LR. From efficacy to safety: a Polycythemia Vera Study group report on hydroxyurea in patients with polycythemia vera. Semin Hematol. 1997 Jan;34(1):17-23. Review.

ReferenceCitation: Kiladjian JJ, Bernard JF, Fenaux P. Is life expectancy of polycythemia vera patients clearly different from that of the general population? Am J Med. 2005 May;118(5):565; author reply 565-6.

ReferenceCitation: Lengfelder E, Berger U, Hehlmann R. Interferon alpha in the treatment of polycythemia vera. Ann Hematol. 2000 Mar;79(3):103-9. Review.

ReferenceCitation: Streiff MB, Smith B, Spivak JL. The diagnosis and management of polycythemia vera in the era since the Polycythemia Vera Study Group: a survey of American Society of Hematology members' practice patterns. Blood. 2002 Feb 15;99(4):1144-9.

ReferenceCitation: Kiladjian JJ, Cassinat B, Chevret S, Turlure P, Cambier N, Roussel M, Bellucci S, Grandchamp B, Chomienne C, Fenaux P. Pegylated interferon-alfa-2a induces complete hematologic and molecular responses with low toxicity in polycythemia vera. Blood. 2008 Oct 15;112(8):3065-72. doi: 10.1182/blood-2008-03-143537. Epub 2008 Jul 23.

name: Assistance Publique-Hôpitaux de Paris, Hôpital Avicenne, Service d'Hématologie Clinique and Paris 13 University, Bobigny;

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

name: Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, Unité de Biologie Cellulaire, Paris;

family: Cassinat

full_name: Bruno Cassinat

given: Bruno

name: Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, DBIM, Paris;

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

name: CHU Dupuytren, Service d'Hematologie, Limoges;

family: Turlure

full_name: Pascal Turlure

given: Pascal

name: CHRU de Lille, Hopital Huriez, Service des Maladies du Sang, Lille;

family: Cambier

full_name: Nathalie Cambier

given: Nathalie

name: Service d'Hématologie, CHU Purpan, Toulouse;

family: Roussel

full_name: Murielle Roussel

given: Murielle

name: Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisiere, Service d'Hématologie, Paris; and

family: Bellucci

full_name: Sylvia Bellucci

given: Sylvia

name: Inserm U656 and Assistance Publique-Hôpitaux de Paris, Service de Biochimie Hormonale et Génétique, Hôpital Bichat and Paris 7 University, Paris, France

family: Grandchamp

full_name: Bernard Grandchamp

given: Bernard

family: Chomienne

full_name: Christine Chomienne

given: Christine

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Kiladjian JJ, Cassinat B, Turlure P, Cambier N, Roussel M, Bellucci S, Menot ML, Massonnet G, Dutel JL, Ghomari K, Rousselot P, Grange MJ, Chait Y, Vainchenker W, Parquet N, Abdelkader-Aljassem L, Bernard JF, Rain JD, Chevret S, Chomienne C, Fenaux P. High molecular response rate of polycythemia vera patients treated with pegylated interferon alpha-2a. Blood. 2006 Sep 15;108(6):2037-40. Epub 2006 May 18.

lead_sponsor: PV-Nord

location_facility:
Hopital Huriez
Hopital Avicenne
Hopital Lariboisiere
Hopital Saint-Louis
Hopital Dupuytren


summary: Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma

ReferenceCitation: Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42.

ReferenceCitation: Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Français du Myélome. N Engl J Med. 1996 Jul 11;335(2):91-7.

location_facility:
Service d'hématologie, CHU Purpan
Rhumatologie, CHU Rangueil
Médecine Interne, Hôpital Rangueil
Médecine Interne, CHU Purpan
Rhumatologie, CHU Purpan