summary: The purpose of this study is to evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell mediator release, unresponsive to optimal symptomatic treatment.

ReferenceCitation: Paul C, Sans B, Suarez F, Casassus P, Barete S, Lanternier F, Grandpeix-Guyodo C, Dubreuil P, Palmerini F, Mansfield CD, Gineste P, Moussy A, Hermine O, Lortholary O. Masitinib for the treatment of systemic and cutaneous mastocytosis with handicap: a phase 2a study. Am J Hematol. 2010 Dec;85(12):921-5. doi: 10.1002/ajh.21894.

ReferenceCitation: Lortholary O, Chandesris MO, Bulai Livideanu C, Paul C, Guillet G, Jassem E, Niedoszytko M, Barete S, Verstovsek S, Grattan C, Damaj G, Canioni D, Fraitag S, Lhermitte L, Georgin Lavialle S, Frenzel L, Afrin LB, Hanssens K, Agopian J, Gaillard R, Kinet JP, Auclair C, Mansfield C, Moussy A, Dubreuil P, Hermine O. Masitinib for treatment of severely symptomatic indolent systemic mastocytosis: a randomised, placebo-controlled, phase 3 study. Lancet. 2017 Feb 11;389(10069):612-620. doi: 10.1016/S0140-6736(16)31403-9. Epub 2017 Jan 7.

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

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

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

repository_institution: OSF Preprints - OSF Preprints

repositories:
HAL
PubMed Central
share.osf.io

repositories_concat: HAL;PubMed Central;share.osf.io

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

ReferenceCitation: Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.

location_facility: Almazov National Medical Research Centre

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: Dnipropetrovsk Clinical Association of Emergency Medical Care of Dnipropetrovsk Regional

location_facility: The University Hospital in Krakow (Szpital Uniwersytecki w Krakowie)

location_facility: Centre de référence de Mastocytose (CEREMAST)

location_facility: University Hospital in Bucharest (Spitalul Universitar de Urgență București)

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire d'Amiens

title: Phase 3 Study to Compare Oral Masitinib to Placebo in Treatment of Patients With Smouldering or Indolent Severe Systemic Mastocytosis, Unresponsive to Optimal Symptomatic Treatment

location_country:
Germany
Poland
United Kingdom
Romania
Netherlands
Ukraine
Russian Federation
France


title: A Prospective,Multicenter, Phase II Study to Evaluate the Contribution of the Imaging TEP to the Expression of intégrines αvβ3 for the Characterization of the Residual Masses of Non-seminoma Tumors at the End of Chemotherapy

acronym: TERMATEP

summary:
The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy.

The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU
Institut Claudius Regaud
CHU Rouen
Centre François Baclesse
Centre Henri Becquerel

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed

appel_a_projets: PHRCI

region: Normandie

nom_etablissement: CRLCC FRANCOIS BACLESSE - CAEN

type_etablissement: CLCC

acronyme: TERMATEP

titre: Apport de l'imagerie de l'expression des intégrines alpha-v beta-3 pour la caractérisation des masses résiduelles de tumeurs non séminomateuses en fin de chimiothérapie

discipline_principale: autre

nom_porteur: AIDE

prenom_porteur: Nicolas


type: EudraCT Number

title: Bivalirudin Infusion for Ventricular Infarction Limitation

acronym: BIVAL

summary: The purpose of this study is to evaluate whether the use of bivalirudin will reduce extent of the damage done to the heart muscle in participants who suffered a heart attack, compared to the comparator treatment (heparin).

study_start_date_type: Actual

status: Terminated

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Alderman EL, Stadius M. The angiographic definitions of the Bypass Angioplasty Revascularization Investigation. Coronary Artery Disease 1992;3: 1189-1207

ReferenceCitation: Graham MM, Faris PD, Ghali WA, Galbraith PD, Norris CM, Badry JT, Mitchell LB, Curtis MJ, Knudtson ML; APPROACH Investigators (Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease. Validation of three myocardial jeopardy scores in a population-based cardiac catheterization cohort. Am Heart J. 2001 Aug;142(2):254-61. doi: 10.1067/mhj.2001.116481.

ReferenceCitation: Kim RJ, Fieno DS, Parrish TB, Harris K, Chen EL, Simonetti O, Bundy J, Finn JP, Klocke FJ, Judd RM. Relationship of MRI delayed contrast enhancement to irreversible injury, infarct age, and contractile function. Circulation. 1999 Nov 9;100(19):1992-2002. doi: 10.1161/01.cir.100.19.1992.

ReferenceCitation: Lowe JE, Reimer KA, Jennings RB. Experimental infarct size as a function of the amount of myocardium at risk. Am J Pathol. 1978 Feb;90(2):363-79.

ReferenceCitation: Ortiz-Perez JT, Meyers SN, Lee DC, Kansal P, Klocke FJ, Holly TA, Davidson CJ, Bonow RO, Wu E. Angiographic estimates of myocardium at risk during acute myocardial infarction: validation study using cardiac magnetic resonance imaging. Eur Heart J. 2007 Jul;28(14):1750-8. doi: 10.1093/eurheartj/ehm212. Epub 2007 Jun 22.

ReferenceCitation: Reimer KA, Ideker RE, Jennings RB. Effect of coronary occlusion site on ischaemic bed size and collateral blood flow in dogs. Cardiovasc Res. 1981 Nov;15(11):668-74. doi: 10.1093/cvr/15.11.668.

ReferenceCitation: Seiler C, Kirkeeide RL, Gould KL. Basic structure-function relations of the epicardial coronary vascular tree. Basis of quantitative coronary arteriography for diffuse coronary artery disease. Circulation. 1992 Jun;85(6):1987-2003. doi: 10.1161/01.cir.85.6.1987.

ReferenceCitation: Seiler C, Kirkeeide RL, Gould KL. Measurement from arteriograms of regional myocardial bed size distal to any point in the coronary vascular tree for assessing anatomic area at risk. J Am Coll Cardiol. 1993 Mar 1;21(3):783-97. doi: 10.1016/0735-1097(93)90113-f.

ReferenceCitation: Wu E, Judd RM, Vargas JD, Klocke FJ, Bonow RO, Kim RJ. Visualisation of presence, location, and transmural extent of healed Q-wave and non-Q-wave myocardial infarction. Lancet. 2001 Jan 6;357(9249):21-8. doi: 10.1016/S0140-6736(00)03567-4.

lead_sponsor: The Medicines Company

location_country: Netherlands France

location_facility:
Hospital Lariboisière
VUMC Amsterdam
Hopital Ambroise Paré
Erasmus Medical Center

intervention_type: Procedure

status_simplified: Unknown


type: Other Identifier

title: Randomized Controlled Study Evaluating the Effect of a Biotherapy Treatment (Anti-RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease

acronym: HDENO

summary:
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:

on bone mineral density (femoral T-score) at 24 months
on bone mineral density evolution (femoral T-score) after 24 months of follow-up
on bone mineral density evolution (lumbar T-score) after 24 months of follow-up
on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up
on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of follow-up
on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
the tolerance after 24 months of follow-up

ReferenceType: derived

ReferenceCitation: Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

ipd_sharing: No

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Montpellier, Nephrology department
CH Perpignan, Nephrology department
Clinique Médipole Cabestany
CHU Lyon Sud, Nephrology department
AP-HM, Nephrology department
CHU Nimes, Nephrology department
CHL Castelnau Le Lez
AIDER
CHU Nice, Nephrology department

intervention_type: Drug

lead_sponsor_type: academique

region: Occitanie

nom_etablissement: CHU MONTPELLIER

type_etablissement: CH

acronyme: HDENO

titre: Etude contrôlée randomisée, évaluant l'effet d'un traitement par biothérapie (anticorps anti-RANK ligand: Denosumab) sur le métabolisme osseux et vasculaire chez des patientes insuffisantes rénales chroniques (stade 5D) ostéoporotiques

nom_porteur: CRISTOL

prenom_porteur: Jean-Paul


title: New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis

summary: To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 7 year follow-up.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Supportive Care

enrollment_type: Anticipated

location_facility: CHU Montpellier, Endocrinology department

location_facility: CHU Montpellier, Internal medicine department

status_simplified: Ongoing


title: Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

summary: The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Phenox GmbH

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Romania
Belgium
Bulgaria
Russian Federation
France

location_facility: Ospedale Bellaria Carlo Alberto Pizzardi

location_facility: Uniwersytecki Szpital Kliniczny we Wroclawiu

location_facility: Federal Almazov North-West Medical Research Centre

location_facility: Hôpital Gui de Chauliac (CHU Montpellier)


title: Multi-center, National, Randomized, Exploratory Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare Pathways (ETAPES Program) Compared to Standard of Care in Patients With Chronic Respiratory Failure Receiving Non-invasive Home Ventilation (e-VENT)

acronym: e-VENT

summary:
The ETAPES Program, a French national Experimentation in Telemedicine for the Improvement of Healthcare Pathways, was launched in 2018 for 4 years. Its objectives were to provide a temporary public reimbursement for medical telemonitoring in order to determine the benefits for the patient and the impact on medical organization and healthcare costs. In particular, this program applies to patients suffering from hypercapnic chronic respiratory failure and requiring home non invasive ventilation (NIV). For these patients, the ETAPES program combines NIV telemonitoring and therapeutic education.

e-VENT study aims at evaluating the ETAPES program, implemented using the Chronic Care Connect™ telemonitoring solution, versus Standard of Care, on the effectiveness of home NIV, measured by average PtCO2, reflecting the level of nocturnal alveolar hypoventilation.

primary_purpose: Health Services Research

lead_sponsor: Air Liquide Santé International

location_facility: Groupe Médical de Pneumologie, Polyclinique Saint Laurent

location_facility: Groupe Hospitalier Pitié Salpêtrière-Charles Foix

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey

location_facility: Hôpital Forcilles - Fondation Cognacq-Jay

location_facility: Centre Hospitalier Universitaire de Tours - Hôpital Bretonneau

location_facility: François BUGHIN, MD - Clinique du Millénaire

intervention_type: Device


title: Essai thérapeutique randomisé Multicentrique en Double Insu, Comparant l'énoxaparine 40mg Versus Placebo, en Une Injection Sous-cutanée Quotidienne, Dans Les Fausses Couches spontanées récurrentes inexpliquées

acronym: PREFIX

summary: Standard investigations fail to reveal any apparent cause in 50% of the cases of recurrent spontaneous abortion. Prothrombotic mechanisms were initially evoked. Factor V Leiden, Prothrombin G20210A mutation and protein S deficiency are implicated in the meta-analysis of Rey (Lancet).However, they do not account for a large number of miscarriages.Gris JC and coworkers (Blood 2004)carried out an open trial, low-molecular-weight heparin versus low-dose aspirin, in women with one fetal loss and with a constitutional thrombophilic disorder. They conclude for a benefit action of Low-molecular-weight heparin. There is actually no trials concerning women with unexplained recurrent abortions and without known thrombophilia. Nevertheless,aspirin or enoxaparin are often prescribed. It is time to assess these practices. We therefore initiate a multisite, double blind randomized study, enoxaparine versus placebo, in women without known thrombophilia, which experienced unexplained recurrent abortions.

ReferenceCitation: Pasquier E, de Saint Martin L, Bohec C, Chauleur C, Bretelle F, Marhic G, Le Gal G, Debarge V, Lecomte F, Denoual-Ziad C, Lejeune-Saada V, Douvier S, Heisert M, Mottier D. Enoxaparin for prevention of unexplained recurrent miscarriage: a multicenter randomized double-blind placebo-controlled trial. Blood. 2015 Apr 2;125(14):2200-5. doi: 10.1182/blood-2014-11-610857. Epub 2015 Jan 30.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

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

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

lead_sponsor: University Hospital, Brest

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de St Etienne

location_facility: Centre Hospitalier Régional Universitaire de Caen


title: Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters

summary: The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.

ReferenceCitation: Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

lead_sponsor: Coloplast A/S

location_country: Germany France Norway Denmark Sweden

location_facility: Hôpital Tenon, Neuro-Urology and perineal explorations department,

location_facility: Hôpital Henry Gabrielle, Urology clinic,

location_facility: PrivatHospitalet Danmark, privat hospital,

location_facility: University Heidelberg, Neuro-Urology clinic,

location_facility: Hôpital Raymond Poincaré, Urology clinic

location_facility: Hôpital Léon Berard, Rehabilitation clinic,

location_facility: St. Olavs Hospital HF, Neurologi clinic,


title: A Randomized Controlled Study of Velcade (Bortezomib) Plus Thalidomide Plus Dexamethasone Compared to Thalidomide Plus Dexamethasone for the Treatment of Myeloma Patients Progressing or Relapsing After Autologous Transplantation

summary:
This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed, or relapsed, at least one year after transplantation.

Eligible patients will be randomly assigned to one of two treatments: either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone.

Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression (measure of time after the disease is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.

lead_sponsor: European Society for Blood and Marrow Transplantation

collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Germany
Italy
Hungary
Israel
United Kingdom
Switzerland
Austria
Belgium
Czechia
France

location_facility: Ospedale SS. Antonio e Biagio e Cesare Arrigo


title: A Prospective, Multicenter, Double-randomized, Double-blind, 2-parallel Groups, Phase 3 Study to Compare as First Line Therapy Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Gemcitabine in Combination With Placebo, in the Treatment of Patients With Non Resectable Locally Advanced or Metastatic Pancreatic Cancer

summary: The objective is to compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with locally advanced or metastatic pancreatic cancer and who have pain related to the disease.

ipd_sharing: Undecided

lead_sponsor: AB Science

location_country:
India
Slovakia
Tunisia
Belgium
Greece
Ukraine
Russian Federation
France

location_facility:
General University Hospital of Patras
Polyclinique de Limoges site CHENIEUX
Centre Hospitalier de Longjumeau
Center of Surgical Innovations
Hospital AZ Sint-Jan
National Oncology Institute
Institut Salah Azaiez de Cancerologie
Sanjeevani CBCC USA Cancer Hospital
Omsk Clinical oncology dispensary Omsk


title: Prospective Multicentric Randomized Trial of Efficiency and Safety of Laparoscopic Omega Loop Bypass Versus Roux-en-Y Gastric Bypass

acronym: YOMEGA

summary:
Several prospective trials and metaanalysis have demonstrated the superiority of bariatric surgery on the medical treatment of obesity. The Roux-en-Y Gastric ByPass (RYGBP) procedure has been practiced for more than 30 years, and is the procedure of choice for morbidly obese with metabolic disorders in most of the reference centers. Nevertheless, the RYGBP is a technically demanding procedure with a learning curve of more than 75 cases. The complication rate is around 10% in expert centers.

More recently another procedure has been described which seems as efficient on weight loss and co-morbidities as the RYGBP, with the advantage of being less technically difficult and less morbid, especially for multi-complicated obese and/or the super obese. It consists of a unique gastro-jejunal anastomosis between a long gastric pouch and a jejunal Omega loop. However, this procedure could be at risk of biliary reflux and anastomotic ulcers with dysplastic changes of the gastric and esophageal mucosa. As a result, the Omega loop bypass (OLB) has only been developed by a few teams and remains a controversial subject, particularly as only one monocentric randomized trial has compared it to the RYGBP, which is remains the gold standard. The first litterature results show similar or even better weight loss efficiency than RYGBP with a better feasibility. The early complication rate seems lower, but there are still insufficient data on long term morbidity and biliary reflux consequences.

By performing a randomized and prospective comparison of OLB to RYGBP, the aim of the investigators study is to analyze the weight loss efficiency, the morbidity and mortality, the feasibility, and the quality of life of both techniques, in order to validate the Omega loop bypass as a procedure of choice in bariatric surgery

Hypothesis :

The OLB, while being as efficient as RYGBP on weight loss and metabolic complications, could be less morbid.

ReferenceCitation: Robert M, Espalieu P, Pelascini E, Caiazzo R, Sterkers A, Khamphommala L, Poghosyan T, Chevallier JM, Malherbe V, Chouillard E, Reche F, Torcivia A, Maucort-Boulch D, Bin-Dorel S, Langlois-Jacques C, Delaunay D, Pattou F, Disse E. Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial. Lancet. 2019 Mar 30;393(10178):1299-1309. doi: 10.1016/S0140-6736(19)30475-1. Epub 2019 Mar 6. Erratum In: Lancet. 2019 Mar 30;393(10178):1298.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

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

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Chirurgie Générale - Hôpital Privé de la Loire

location_facility: Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche

location_facility: Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière

location_facility: Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP

location_facility: Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye

location_facility: Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille

location_facility: Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire

location_facility: Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: YOMEGA

titre: Etude prospective, multicentrique, randomisée, contrôlée de l'efficacité et de la sécurité du bypass gastrique laparoscopique en Oméga versus le bypass gastrique avec anse en Y.

discipline_principale: chirurgie viscérale et digestive

nom_porteur: ROBERT

prenom_porteur: Maud


title: An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)

acronym: SOLSTICE

summary: The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

status: Active, not recruiting

ipd_sharing: Yes

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

sponsor_collaborators: Institut de Recherches Internationales Servier

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Czechia
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
Latvia
Ukraine
Romania
Estonia
Italy
United Kingdom
Netherlands
Austria
Spain
Bulgaria
Russian Federation
Sweden

location_facility: Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly

location_facility: Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia

location_facility: Thomayerova nemocnice Onkologicka klinika 1. LF UK a TN

location_facility: Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre

location_facility: Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale

location_facility: Tartu University Hospital, Hematology - Oncology clinic, Radiotherapy and oncological therapy

location_facility: Semmelweis University Radiology and Oncotherapy Clinic

location_facility: Centro de Oncología e Investigación de Buenos Aires COIBA

location_facility: Leicester Royal Infirmary The HOPE Clinical Trials Unit

location_facility: INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica

location_facility: Spitalul Clinic "Coltea" Sectia Oncologie Medicala

location_facility: "Complex Ongology Center - Vratsa" EOOD Department of Medical oncology

location_facility: S.C ONCOMED S.R.L Departament Oncologie Medicala

location_facility: Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu Sectia Oncologie Medicala

location_facility: "Complex oncology center - Burgas" EOOD Department of medical oncology

location_facility: Lviv Regional Oncology Center Chemotherapy department

location_facility: Pecsi Tudomanyegyetem, Klinikai Kozpont Onkoterapias Intezet

location_facility: Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica

location_facility: "UMHAT Sv. Ivan Rilski" EAD Clinic of clinical hematology, Dpt. of medical oncology

location_facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

location_facility: Sirio Libanes DF - Centro de Oncologia de Braslia do Sirio- Centro Intergrado de Pesquisa

location_facility: Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", proctology department

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

location_facility: Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei

location_facility: Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy

location_facility: Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V

location_facility: Centro Hospitalar Lisboa Norte, Hospital de Santa Maria Serviço de Oncologia Médica

location_facility: Hospital A C Camargo Unidade de Pesquisa Clinica

location_facility: Podillia Regional Oncology Centre Chemotherapy Department

location_facility: Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)

location_facility: CHU Morvan Institut de Cancérologie et d'Hématologie

location_facility: Hospital Unviersitario Gregorio Marañon Servicio de Oncología Médica

location_facility: University Hospitals Bristol Bristol Haematology & Oncology Centre

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa

location_facility: Centro de Pesquisa Hospital de Caridade de Ijuí Unidade de Pesquisa Clínica

location_facility: Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii

location_facility: CHU Jean Minjoz Service d'oncologie médicale

location_facility: Masarykuv onkologicky ustav Klinika komplexni onkologicke pece

location_facility: Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III

location_facility: Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale

location_facility: P. Stradins Clinical University Hospital

location_facility: Scientific Centre for Specialized Medical Care (oncological) Chemotherapy

location_facility: Albert Schweitzer Ziekenhuis Interne Geneeskunde

location_facility: Pyatigorsk Interdistrict Oncology Dispensary Chemotherapy department

location_facility: Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Oddzial Kliniczny Onkologii i Immunoonkologii

location_facility: Hospital Quirónsalud Valencia Servicio de Oncología Médica

location_facility: Hospital Beatriz Ângelo Serviço de oncologia medic

location_facility: NU-MED Centrum Diagnostyki i Terapii Onkologicznej Tomaszów Mazowiecki II Sp. z o.o., Pododdzial Chemioterapi

location_facility: Spec. hospital for active treatment of oncology dis. EOOD Department of medical oncology and palliative care

location_facility: Centre Antoine Lacassagne Dpt d'Oncologie Médicale

location_facility: H. Universitario La Paz Oncología Médica

location_facility: Fakultni nemocnice Olomouc Onkologicka klinika

location_facility: North Estonia Medical Centre Foundation Oncology and Haematology clinic

location_facility: S.C Oncolab S.R.L Sectia Oncologie Medicala

location_facility: Kyiv City Clinical Oncology Centre Chemotherapy Department #2

location_facility: Med. Universität Graz Klinische Abteilung für Onkologie

location_facility: Uzsoki Utcai Korhaz Onkoradiologiai Osztaly

location_facility: Hospital de la Santa Creu I Sant Pau Oncología Medica

location_facility: University Headache Clinic Outpatient oncology clinic

location_facility: Norrlands Universitetssjukhus Cancercentrum Umea

location_facility: Christie Hospital NHS Foundation Trust GI & Endocrine

location_facility: "Complex oncology center - Plovdiv" EOOD, IInd base Dpt. of Med. oncology and onc. diseases in gastroenterology

location_facility: MHAT Serdika EOOD Department of Medical Oncology

location_facility: Hospital General Universitario Alicante Servicio de Oncología

location_facility: MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" Department of Oncology

location_facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

location_facility: A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2

location_facility: Odense Universitetshospital Onkologisk Afdeling R

location_facility: Fakultni nemocnice Ostrava Klinika onkologicka

location_facility: Vseobecna fakultni nemocnice Onkologicka klinika VFN a 1. LF UK

location_facility: Hospital Garcia de Orta Serviço de Oncologia Médica

location_facility: Clinical Oncology Dispensary No.1 Chemotherapy Department

location_facility: Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie

location_facility: Policlinico Universitario Campus Biomedico UOC di Oncologia Medica

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.

location_facility: Ordensklinikum Linz Barmherzige Schwestern Interne I

location_facility: Cork University Hospital Department of Medical Oncology

location_facility: Oncology Hospital, Branch of Hospital of Lithuanian Uni. of Health Sciences Kauno klinikos

location_facility: Hospital Universitario Miguel Servet Servicio de Oncología

location_facility: Arkhangelsk Clinical Oncology Dispensary chemotherapy department

location_facility: Hospital Universitario Ramón y Cajal, Servicio de Oncologia Médica

location_facility: Frankston Private Peninsula and Southeast Oncology Group

location_facility: Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica

location_facility: Karolinska University Hospital, Solna Studiebehandlingsenheten, B8:09

location_facility: SBIH of YR "Clinical oncology hospital" chemotherapy department

location_facility: Institute of Medical Radiology of S.P. Grygoryev of AMS UKR

location_facility: Istituto Nazionale Tumori I.R.C.C.S "Fondazione G. Pascale" Struttura Complessa di Oncologia Medica Addominale

location_facility: Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1

location_facility: Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej

location_facility: JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: Hospital de Base Centro Integrado de Pesquisa

location_facility: Catharina Ziekenhuis Interne Gesneeskunde/Oncologie

location_facility: Hopital Haut-Leveque Hepato-gastroenterologie et oncologie digestive

location_facility: Adventist HealthCare Integrated Cancer Centre

location_facility: Hospital Universitario Marqués de Valdecilla Oncología médica

location_facility: Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin I

location_facility: Hospital of Lithuania Univ of Health Sciences Kauno klinikos Oncology Institute

location_facility: H. Clínico San Carlos Servicio de Oncología Médica

location_facility: Centrul de Oncologie Sf Nectarie Oncology Department

location_facility: National Medical Research Center of Oncology N.N. Petrova

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak Onkoradiologiai Osztaly

location_facility: Lanssjukhuset Ryhov Onkologiska kliniken

location_facility: Arcispedale Santa Maria Nuova Unità di Oncologia

location_facility: Blacktown Hospital Cancer and Haematology Centre

location_facility: Ospedale San Carlo U.O. Oncologia Medica

location_facility: Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling

location_facility: Azienda Socio Sanitaria Territoriale di Cremona ONCOLOGIA

location_facility: Riga East Univerity Hospital Oncology Centre of Latvia

location_facility: Hospital Germans Trias i Pujol Unidad de Investigación clínica (UIC) ICO-Oncología medica

location_facility: National Institute of Cancer Abdominal Oncology Department

location_facility: St George Hospital St George Hospital Cancer Care Centre

location_facility: State Research Institution of Oncology of Tomsk Chemotherapy

location_facility: "Medical Center Nadezhda Clinical" EOOD Medical Oncology Department

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncol Centro Intergrado de Pesquisa

location_facility: Instituto Português de Oncologia do Porto FG, EPE -IPO Porto Medical Oncology Dept.

location_facility: Hospital São Rafael Centro Intergrado de Pesquisa

location_facility: SHAT of oncology diseases Dr. Marko Antonov Markov" EOOD Department of medical oncology and palliative therapy

location_facility: Markusovsky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly

location_facility: M. Kopernika Provincial Hospital Oddzial Chemioterapii Nowotworow

location_facility: H. Valle de Hebrón Servicio de Oncología - (VHIR)

location_facility: IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia

location_facility: Ospedale S. Bortolo -ULSS8 Berica Distretto Est U.O. ONCOLOGIA

location_facility: Aalborg Universitetshospital, Syd Onkologisk Afdelin

location_facility: Narodny onkologicky ustav Oddelenie klinickej onkologie

location_facility: HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica

location_facility: "Multiprofile hosp. for active treatmen Dr. Tota Venkova" AD Department of medical oncology

location_facility: CHU Toulouse Rangueil Oncologie médicale digestive

location_facility: Regional Clinical Oncological Dispensary Department of Oncology

location_facility: Kursk Regional Clinical Oncology Dispensary Oncology Department

location_facility: Institutul Oncologic "Prof Alexandru Trestioreanu" Busuresti Sectia Oncologie Medicala I

location_facility: Odesa Regional Oncology Dispensary Day patient Department

location_facility: Sarah Cannon Research Institute UK Clinical Trials

location_facility: Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales

location_facility: Hôpital Saint-Antoine Service d'Oncologie Médicale

location_facility: Aberdeen Royal Infirmary Oncology Department

location_facility: Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit

location_facility: Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica

location_facility: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj Napoca Oncologie Medicala

location_facility: Del-Pesti Centrumkh-Orsz. Hematologiai es Infektologiai Int. Szent Laszlo Telephely

location_facility: Centro Hospitalar e Universitário de Coimbra - CHUC Unidade de Inovação e Desenvolvimento (UID)

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika

location_facility: Fundación COIR Centro Oncológico de Interación Regional

location_facility: Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive

location_facility: Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

location_facility: Szent Imre Egyetem Oktatokorhaz Klinikai Onkologia

location_facility: Moscow City Oncology Hospital # 62 chemotherapy department

location_facility: Glan Clwyd Hospital North Wales Cancer Treatment Centre

location_facility: East Tallinn Central Hospital Center of Oncology

location_facility: Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie

location_facility: Rostov Research Institute of Oncology Chemotherapy department

location_facility: Omsk Clinical Oncologic Dispensary Chemotherapy

location_facility: Royal Marsden Hospital Department of Medicine


title: Evaluation of Tele-expertise for Inmates With a Dermatological Lesion

acronym: TLM-Inmates

summary: The purpose of this study is to determine whether Tele-expertise would be effective and cost-effective by reducing the number of secure transportations for inmates in need of a dermatological consultation

time_perspective: Retrospective

ReferenceCitation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

ReferenceCitation: Zarca K, Charrier N, Mahe E, Guibal F, Carton B, Moreau F, Durand-Zaleski I. Tele-expertise for diagnosis of skin lesions is cost-effective in a prison setting: A retrospective cohort study of 450 patients. PLoS One. 2018 Sep 24;13(9):e0204545. doi: 10.1371/journal.pone.0204545. eCollection 2018.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

publisher_dissemination: Springer-Nature

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Agence Regionale de Sante d'Ile de France

location_facility:
UCSA Nanterre
UCSA Meaux
UCSA Réau
UCSA Osny
UCSA Villepinte


title: Assessment of Teleconsulting in Nursing Homes to Avoid Transportations to the Emergency Units

summary: The purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents.

sponsor_collaborators: Agence Regionale de Sante d'Ile de France

location_facility:
Résidence Les Tisserins
Résidence Notre Dame d'Espérance
Résidence La Gentilhommière
Le Centenaire
Résidence de l'Orge


title: Effect of Lipidic Nutrients on Memory and Well Being in Healthy Aging Adults

acronym: NUTRIMEMO

summary: Nutrimemo aims to study the effect of a daily consumption of a mix of vitamin A and long chain n-3 Polyunsaturated Fatty Acids (PUFA) on the evolution of cognitive functions in healthy elderly subjects. The study is a randomized, double bind, parallel-groups (2 arms) placebo-controlled design.

status: Unknown status

primary_purpose: Prevention

lead_sponsor: Nutrimemo Consortium

collaborators: Laboratory of Nutrition And Integrative Neurbiology INRA - Bordeaux University

location_facility: Universitary Hospital Center - USR 3413 SANPSY


title: Improve the Survival Without Morbidity of Extremely Preterm Infants: A Stepped-wedge Cluster-randomized Trial

acronym: PREMEX

summary:
The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of women hospitalized for a risk of extremely preterm birth and their children. It will take place in each perinatal network for all pregnant women hospitalized between 22 and 26 weeks with a risk of preterm delivery.

Setting up the protocol requires taking into account the parents' time and timing issues, and its potential for change, to plan the implementation of the protocol, especially the degree of emergency of the situation and the probability of imminent delivery.

The follow-up collected for this study will take place:

At D4 post-delivery: A questionnaire about the parents' experience of the information delivered and the decisions made will be given to and collected from the parents

At the child's discharge from the hospital, or if he or she dies in the hospital:

Collection of clinical data (principal endpoint) from data in the medical file.
Data to measure practices and adherence to the intervention will be collected

When the child reaches the corrected age of 2 years:

a short questionnaire will be completed by the physician caring for the child at the corrected age of 2 years. The data collected will concern motor and sensory development, in particular, cerebral palsy, blindness, and deafness..
Information about the child's development will also be collected with a questionnaire including a standardized assessment scale, the ASQ (Ages and Stages Questionnaire), which the parents will complete.

ReferenceCitation: Lamau MC, Ruiz E, Merrer J, Sibiude J, Huon C, Lepercq J, Goffinet F, Jarreau PH. A new individualized prognostic approach to the management of women at risk of extreme preterm birth in France: Effect on neonatal outcome. Arch Pediatr. 2021 Jul;28(5):366-373. doi: 10.1016/j.arcped.2021.04.005. Epub 2021 May 28.


title: Evaluation of the Efficacy of 6% Hydroxyethyl Starch (HES, 130/0.4) in Normal Saline Compared to Ringer's Lactate Solution for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section

acronym: CAESAR

summary: The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section

ReferenceCitation: Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.

ReferenceCitation: Mercier FJ, Diemunsch P, Ducloy-Bouthors AS, Mignon A, Fischler M, Malinovsky JM, Bolandard F, Aya AG, Raucoules-Aime M, Chassard D, Keita H, Rigouzzo A, Le Gouez A; CAESAR Working Group. 6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial. Br J Anaesth. 2014 Sep;113(3):459-67. doi: 10.1093/bja/aeu103. Epub 2014 Jun 26.

oa_host_type: publisher

evidence: open (via crossref license)

repositories_concat: closed

lead_sponsor: Fresenius Kabi

location_facility: Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale

location_facility: Hopital Caremeau, CHU, Service Anesthesie

location_facility: Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre

location_facility: CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation

location_facility: Hopital Robert Debre, CHU, Service Anesthesie

location_facility: Höpital Louis-Mourier - Service d'Anesthesie

location_facility: Unité d'anesthésie - Maternité Paule de Viguier

location_facility: Hopital de l'Archet, Service Anesthesie-Reanimation

location_facility: Hôpital Armand-Trousseau, Service d'anesthésie-réanimation

location_facility: Hopital Hautepierre, CHU, Service Reanimation Chirurgicale

location_facility: Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation


title: Flow Cytometric Analysis of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes: A Pilot Diagnostic Accuracy Study

acronym: MPO-MDS-PILOT

summary:
Myelodysplastic syndromes (MDS) constitute a heterogeneous group of clonal bone marrow neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years. MDS are characterized by peripheral blood cytopenia and morphologic dysplasia for one or more hematopoietic cell lineage, reflecting ineffective hematopoiesis.

The diagnostic work-up of MDS includes a bone marrow aspirate and biopsy, which is an invasive procedure, for cytomorphologic and cytogenetic evaluations. Because the prevalence of disease is lower than 20% in subjects referred for suspected MDS, many patients are exposed to unnecessary bone marrow aspiration-related discomfort and harms.

An objective assay is highly desirable for accurately ruling out MDS based on peripheral blood samples, which may obviate the need for invasive bone marrow aspiration and biopsy in patients with negative results.

Few studies have investigated the value of peripheral blood flow cytometric analysis for the diagnosis of MDS and/or chronic myelomonocytic leukemia (CMML). Although promising, these studies lacked replication of their results, used a case-control design, which was prone to spectrum bias, or yielded imprecise diagnostic accuracy estimates due to relatively limited sample sizes.

Anecdotal evidence supports the potential of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the diagnosis of MDS and CMML. Myeloperoxidase is an enzyme synthetized during myeloid differentiation that constitutes the major component of neutrophil azurophilic granules. Myeloperoxidase expression may reflect neutrophil hypogranulation, which is a classical although subjective dysplastic feature of MDS. Flow cytometric analysis of myeloperoxidase expression in bone marrow neutrophil granulocytes has been used for discriminating low versus high grade MDS. Yet a study reporting on the accuracy of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the diagnosis of MDS is still lacking, to our knowledge.

In this study, the investigators hypothesize that flow cytometric analysis of neutrophil myeloperoxidase expression in peripheral blood may accurately rule out MDS and obviate the need for bone marrow aspiration and biopsy, with sensitivity approaching 100%, in routine practice.

In this observational diagnostic accuracy study, burden will be null for recruited patients. No specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. Flow cytometry analysis of peripheral blood neutrophil myeloperoxidase expression will not require additional blood sample. A test result will have no impact on patient management. No follow-up visits are planned in this cross-sectional study.

time_perspective: Cross-Sectional

ReferenceCitation: Raskovalova T, Scheffen L, Jacob MC, Vettier C, Bulabois B, Szymanski G, Chevalier S, Gonnet N, Park S, Labarere J. Comparative diagnostic accuracy between simplified and original flow cytometric gating strategies for peripheral blood neutrophil myeloperoxidase expression in ruling out myelodysplastic syndromes. PLoS One. 2022 Nov 18;17(11):e0276095. doi: 10.1371/journal.pone.0276095. eCollection 2022.

ReferenceCitation: Raskovalova T, Jacob MC, Bulabois CE, Mariette C, Scheffen L, Park S, Labarere J. Flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for ruling out myelodysplastic syndromes: a prospective validation study. Ann Hematol. 2021 May;100(5):1149-1158. doi: 10.1007/s00277-021-04446-7. Epub 2021 Feb 10.

oa_host_type: closed

ipd_sharing_description: The principal investigators will respond directly to data requests by providing a de-identified data set. Individual participant data that underlie the results reported in the published articles (i.e., main text, tables, figures, and appendices) will be supplied.

lead_sponsor: University Hospital, Grenoble

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

intervention_type: Diagnostic Test


title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ReCap/Magnum in Total Hip Replacement and Resurfacing

summary: Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.

lead_sponsor: Zimmer Biomet

sponsor_collaborators:
Zimmer Biomet
Biomet France SARL

location_facility:
Polyclinique de Hénin Beaumont
Clinique Saint Andre
CHU Hôpital Sud
CHU Pellegrin Tripode
Polyclinique de Riaumont
CHU Amiens


title: Exploration of Sensory-motor Representations in Children of Typical Development Aged 5 to 8

acronym: IMOT

summary: Evaluate the quality of sensorimotor representations in typically developing children aged 5 to 8 years.

primary_purpose: Other

lead_sponsor: Centre Hospitalier de Lens

collaborators: Centre National de la Recherche Scientifique, France

location_facility:
Hôpital Saint Vincent
Hospital Sambre Avesnois
Psychomotor therapist' offices
Hospital Dr Schaffner

intervention_type: Behavioral


title: Identification and Treatments of Basal Like Bladder Cancer (Study on Human Tumor Samples and Animal Models)

acronym: DIATRIBBE

summary: Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and no target therapies for this pathology are currently validated. By 40 gene expression signature realized on frozen samples, we have previously identified an aggressive sub-class of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim is to establish a standard diagnostic tool to differentiate the basal subtype of bladder cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR associated chemotherapy.

collaborators: Institut National de la Santé Et de la Recherche Médicale, France


title: A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.

summary:
Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a polyclonal antibody response.

This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE disease.

ReferenceCitation: Ducreux J, Houssiau FA, Vandepapeliere P, Jorgensen C, Lazaro E, Spertini F, Colaone F, Roucairol C, Laborie M, Croughs T, Grouard-Vogel G, Lauwerys BR. Interferon alpha kinoid induces neutralizing anti-interferon alpha antibodies that decrease the expression of interferon-induced and B cell activation associated transcripts: analysis of extended follow-up data from the interferon alpha kinoid phase I/II study. Rheumatology (Oxford). 2016 Oct;55(10):1901-5. doi: 10.1093/rheumatology/kew262. Epub 2016 Jun 28.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: Université de Lausanne - SERVAL

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

publisher_dissemination: Oxford University Press

ReferenceCitation: Lauwerys BR, Hachulla E, Spertini F, Lazaro E, Jorgensen C, Mariette X, Haelterman E, Grouard-Vogel G, Fanget B, Dhellin O, Vandepapeliere P, Houssiau FA. Down-regulation of interferon signature in systemic lupus erythematosus patients by active immunization with interferon alpha-kinoid. Arthritis Rheum. 2013 Feb;65(2):447-56. doi: 10.1002/art.37785.

lead_sponsor: Neovacs

location_country: Germany Switzerland Belgium Croatia Bulgaria France

location_facility: Centre Hospitalier Universitaire Vaudois

intervention_type: Biological


title: A Prospective Study on Markers of Disease Progression and Gait Within the Parkinsonian Population

acronym: Gait'N'Park

summary:
The aim of the project is to evaluate disease progression of patients with Parkinsonian syndrome of various severity through regular home-based gait parameters analysis.

We identified several steps in this project:

Acquisition of gait data in 120 patients with Parkinsonism at different stages in hospital and ecological condition (during 10 days at home), in a repetitive manner:

30 Early PD patients, before 3 years of disease duration (MDS criteria, 2018)
30 PD patients with motor fluctuations (5 to 8 years of disease duration) (MDS criteria, 2018)
30 PD patients with FoG (10 years of disease duration) (MDS criteria, 2018)
30 patients with MSA (less than 5 years after the first symptom)
Control groups will be composed by 30 healthy volunteers Correlation analysis with clinical measurements and biomarkers, namely blood biomarkers for neurodegeneration (4HN, NFLT …) and multimodal MRI repeated assessments (Iron overload, inflammation and degeneration) and genetic panel for common haplotypes involved in Parkinsonism.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
H. Lundbeck A/S
France Parkinson Association
Vaincre Parkinson
FeetMe


title: French Multicentre Observational Study of a Prospective Cohort of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)

acronym: OPALE

summary:
Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year.

Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-transplantation).

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma S.A.S.


title: A Cohort Study in Liver Transplant Patients Converted From a Tacrolimus Twice a Day (Prograf®) to Tacrolimus Once a Day (Advagraf®). French, Multisite, Observational Study

acronym: COBALT

summary: A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.


title: Study of Efficacy of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy

acronym: Béfinohl

summary: Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations

ipd_sharing_description: Undecided

lead_sponsor: Hôpital Necker-Enfants Malades

sponsor_collaborators:
Hôpital Necker-Enfants Malades
European Georges Pompidou Hospital
CLAIROP


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multi-Center Study Evaluating the Efficacy and Safety of Four Doses of SR147778 in Obese Patients

summary: The purpose of this study is to assess the effect of SR147778 on weight loss over a period of 24 weeks when prescribed with a hypocaloric diet in obese patients. The secondary objective is to assess the safety and tolerability of SR147778 and to assess the effect of SR147778 on several secondary parameters (such as waist, metabolic parameters) over a period of 24 weeks when prescribed with a hypocaloric diet in obese patients.

lead_sponsor: Sanofi

location_country: Finland Argentina Australia Spain France

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: Randomised, Multicentre, Double-blind, Placebo-controlled Study to Assess the Safety, Efficacy and Pharmacodynamics After the Intravenous Administration of CAL02 in Severe Community-acquired Pneumonia Due to Streptococcus Pneumoniae

summary: The objectives of this study are to assess the safety, tolerability, clinical and microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of standard of care antibiotic treatment.

ReferenceCitation: Laterre PF, Colin G, Dequin PF, Dugernier T, Boulain T, Azeredo da Silveira S, Lajaunias F, Perez A, Francois B. CAL02, a novel antitoxin liposomal agent, in severe pneumococcal pneumonia: a first-in-human, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis. 2019 Jun;19(6):620-630. doi: 10.1016/S1473-3099(18)30805-3. Epub 2019 May 2.

lead_sponsor: Combioxin SA

location_country: Belgium France

location_facility:
CHD Les Oudairies
CHU Dupuytren
St Luc University Hospital
Clinique St Pierre
CH Yves Le Foll
CHRU de Tours
University Hospital Brussels
Hôpital Mignot
CHU Jean Minjoz
Centre Hospitalier Régional d'ORLEANS


title: Evaluation of the Efficacy of Sildenafil on Time to Healing in Patients With Scleroderma and Ischaemic Digital Ulcers: a Prospective, Longitudinal, Randomized, Comparative, Double-blind, 2-parallel-arm, Placebo-controlled Study

acronym: SEDUCE

summary: Digital ulcers (DUs) are an expression of the microangiopathy in patients with scleroderma (SSc). DUs lead to pain and impaired hand use. DUs remain a severe complication for many patients and effective therapy remains elusive. In the present study, the investigators propose to evaluate the efficacy of Sildenafil in DUs healing in a randomized double blind control study in SSc patients.

ReferenceCitation: Hachulla E, Hatron PY, Carpentier P, Agard C, Chatelus E, Jego P, Mouthon L, Queyrel V, Fauchais AL, Michon-Pasturel U, Jaussaud R, Mathian A, Granel B, Diot E, Farge-Bancel D, Mekinian A, Avouac J, Desmurs-Clavel H, Clerson P; SEDUCE study group. Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study. Ann Rheum Dis. 2016 Jun;75(6):1009-15. doi: 10.1136/annrheumdis-2014-207001. Epub 2015 May 20.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

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

repositories:
HAL
PubMed Central
open-archive.highwire.org

publisher_dissemination: British Medical Journal

location_facility:
Jean Verdier Hospital
Groupe Hospitalier Paris Saint Joseph
University Hospital, Grenoble
La Pitié - Salpétriêre Hospital
Hôpital Edouard Herriot
CHU Dupuytren / dermatology
CHU de Rennes
CHU Dupuytren / Médecine Interne
University Hospital, Tours
CHU Dijon
Nord Hospital
University Hospital, Amiens
Cochin Hospital / Médecine Interne
Hautepierre Hospital
CHU de Reims
Saint Antoine Hospital
University Hospital, Nantes
Cochin Hospital
University Hospital, Rouen
University Hospital, Lille
St Louis Hospital
University Hospital, Nice
CHU de Caen
University Hospital, Fort de France


title: A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY)

acronym: AFFINITY

summary: This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.

ReferenceCitation: Saad F, Hotte S, North S, Eigl B, Chi K, Czaykowski P, Wood L, Pollak M, Berry S, Lattouf JB, Mukherjee SD, Gleave M, Winquist E; Canadian Uro-Oncology Group. Randomized phase II trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as second-line therapy in patients with metastatic castrate-resistant prostate cancer progressing after first-line docetaxel: CUOG trial P-06c. Clin Cancer Res. 2011 Sep 1;17(17):5765-73. doi: 10.1158/1078-0432.CCR-11-0859. Epub 2011 Jul 25.

ReferenceCitation: Chi KN, Hotte SJ, Yu EY, Tu D, Eigl BJ, Tannock I, Saad F, North S, Powers J, Gleave ME, Eisenhauer EA. Randomized phase II study of docetaxel and prednisone with or without OGX-011 in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Sep 20;28(27):4247-54. doi: 10.1200/JCO.2009.26.8771. Epub 2010 Aug 23.

ReferenceCitation: Beer TM, Hotte SJ, Saad F, Alekseev B, Matveev V, Flechon A, Gravis G, Joly F, Chi KN, Malik Z, Blumenstein B, Stewart PS, Jacobs CA, Fizazi K. Custirsen (OGX-011) combined with cabazitaxel and prednisone versus cabazitaxel and prednisone alone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (AFFINITY): a randomised, open-label, international, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1532-1542. doi: 10.1016/S1470-2045(17)30605-8. Epub 2017 Oct 9.

lead_sponsor: Achieve Life Sciences

location_country:
Hungary
United Kingdom
Australia
United States
Canada
Czech Republic
Russian Federation
France

location_facility: Haematology and Oncology Clinics of Australia

location_facility: R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa

location_facility: Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Smilow Cancer Hospital at Yale New Haven Hospital

location_facility: Semmelweis Egyetem Általános Orvostudományi Kar

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

location_facility: Urology Cancer Center and GU Research Network

location_facility: Saint Petersburg City Oncological Dispensary

location_facility: Chattanooga Oncology and Hematology Associates

location_facility: University of California Davis Medical Center

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie

location_facility: Volgograd Regional Oncological Dispensary

location_facility: Washington University School of Medicine

location_facility: Szegedi Tudományegyetem, Onkoterápiás Klinika

location_facility: California Pacific Medical Center Research Institute

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: The Ottawa Hospital Regional Cancer Centre


title: Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak

acronym: CLIECO

summary: In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders. These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.).

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Centre Hospitalier Esquirol
University hospital of Toulouse
Hôpital Robert-Debré (AP-HP)
Centre Hospitalier de Versailles
Maison de Solenn (Hôpital Cochin AP-HP)


title: Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock

acronym: APROCCHS

summary: This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock

ReferenceCitation: Annane D, Buisson CB, Cariou A, Martin C, Misset B, Renault A, Lehmann B, Millul V, Maxime V, Bellissant E; APROCCHSS Investigators for the TRIGGERSEP Network. Design and conduct of the activated protein C and corticosteroids for human septic shock (APROCCHSS) trial. Ann Intensive Care. 2016 Dec;6(1):43. doi: 10.1186/s13613-016-0147-3. Epub 2016 May 6. Erratum In: Ann Intensive Care. 2016 Dec;6(1):79.

ReferenceType: result

ReferenceCitation: Annane D, Timsit JF, Megarbane B, Martin C, Misset B, Mourvillier B, Siami S, Chagnon JL, Constantin JM, Petitpas F, Souweine B, Amathieu R, Forceville X, Charpentier C, Tesniere A, Chastre J, Bohe J, Colin G, Cariou A, Renault A, Brun-Buisson C, Bellissant E; APROCCHSS Trial Investigators. Recombinant human activated protein C for adults with septic shock: a randomized controlled trial. Am J Respir Crit Care Med. 2013 May 15;187(10):1091-7. doi: 10.1164/rccm.201211-2020OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: University of Versailles

sponsor_collaborators:
University of Versailles
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France

location_facility:
Henri Mondor Hospital
Saint Josef Hospital
Raymond Poincaré Hospital
Pitié Salpêtrière Hospital


title: Efficacy and Safety of Clobetasol Propionate Shampoo 0.05% Used in Association With an Antifungal Shampoo in the Treatment of Moderate to Severe Scalp Seborrheic Dermatitis

acronym: Escape

summary: The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.

ReferenceCitation: Ortonne JP, Nikkels AF, Reich K, Ponce Olivera RM, Lee JH, Kerrouche N, Sidou F, Faergemann J. Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0.05% combined with ketoconazole shampoo 2%: a randomized, controlled study. Br J Dermatol. 2011 Jul;165(1):171-6. doi: 10.1111/j.1365-2133.2011.10269.x.

lead_sponsor: Galderma R&D

location_country:
Germany
Mexico
Belgium
Korea, Republic of
France


title: Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness

summary: This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.

lead_sponsor: Theranexus

location_country:
Germany
Hungary
United States
Czechia
France

location_facility: Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály

location_facility: Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin

location_facility: Neurologická klinika Fakultní nemocnice Ostrava

location_facility: I. neurologická klinika Fakultní nemocnice u sv. Anny

location_facility: Neurologická klinika Fakultní nemocnice Hradec Králové

location_facility: Technische Universität München, Klinikum rechts der Isar, Neurologische Klinik und Poliklinik, Neuro-Kopf-Zentrum

location_facility: CHU de la Timone Service de Neuro et pathologie du mouvement

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály

location_facility: Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West, *ausgelagerte Praxisräume:

location_facility: Neurologické oddělení Nemocnice Na Homolce

location_facility: Praxis Dr. Safavi, Neuroakademie Alzenau

location_facility: Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika

location_facility: Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály

location_facility: Neurologická klinika 1.LF UK a VFN v Praze

location_facility: Neurologische Praxis Dipl. med. Christian Oehlwein

location_facility: ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière

location_facility: MGH Neurological Clinical Research Institute


title: Study on Vascular Function, Sarcopenia and Pain in Treated Postmenopausal Osteoporosis

acronym: VASCO

summary: This study aims to follow a cohort of osteoporotic patients treated with anti-osteoporotic drugs and to evaluate the impact of these treatments on the osteoporosis-cardiovascular-sarcopenia triad and on pain.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Clermont-Ferrand


title: Molecular Targets for the Treatment of Histiocytosis

acronym: TARGET-HISTIO

summary:
The primary objective: to develop technical and operating procedures for detection mutations of histiocytosis during clinical practice of no-specialized molecular platforms, for diagnosis and follow-up of the disease.

The secondary objectives: to describe therapeutic target mutations in histiocytosis patients, and to develop the cellular tests to evaluate in vitro the sensibility of these mutations drive to inhibitors.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Direction de l'Hospitalisation et de l'Organisation des Soins

collaborators: Versailles Saint-Quentin-en-Yvelines University, Paris-Saclay University

location_facility: Biological research center, Ambroise Paré hospital, APHP

location_facility: Department of internal Medicine, Pitié-Salpétrière hospital, APHP

location_facility: Department of Pediatrics, Trousseau hospital, APHP

appel_a_projets: PRTK

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

titre: Cibles moléculaires pour le traitement des histiocytoses.

discipline_principale: cancer

nom_porteur: DONADIEU

prenom_porteur: Jean


title: Definition for the Assessment of Time-to-event Endpoints in CANcer Trials (DATECAN-1) : Formal Consensus Method for the Development of Guidelines for Standardized Time-to-event Endpoints' Definitions in Cancer Clinical Trials

summary:
In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial's results by affecting estimation of treatments' effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials.

We will use a formal consensus methodology based on experts' opinions which will be obtained in a systematic manner.

Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs).

The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials' results.

time_perspective: Other

ReferenceCitation: Puijk RS, Ahmed M, Adam A, Arai Y, Arellano R, de Baere T, Bale R, Bellera C, Binkert CA, Brace CL, Breen DJ, Brountzos E, Callstrom MR, Carrafiello G, Chapiro J, de Cobelli F, Coupe VMH, Crocetti L, Denys A, Dupuy DE, Erinjeri JP, Filippiadis D, Gangi A, Gervais DA, Gillams AR, Greene T, Guiu B, Helmberger T, Iezzi R, Kang TW, Kelekis A, Kim HS, Kroncke T, Kwan S, Lee MW, Lee FT, Lee EW Jr, Liang P, Lissenberg-Witte BI, Lu DS, Madoff DC, Mauri G, Meloni MF, Morgan R, Nadolski G, Narayanan G, Newton I, Nikolic B, Orsi F, Pereira PL, Pua U, Rhim H, Ricke J, Rilling W, Salem R, Scheffer HJ, Sofocleous CT, Solbiati LA, Solomon SB, Soulen MC, Sze D, Uberoi R, Vogl TJ, Wang DS, Wood BJ, Goldberg SN, Meijerink MR. Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative. Radiology. 2021 Dec;301(3):533-540. doi: 10.1148/radiol.2021203715. Epub 2021 Sep 28.

ReferenceCitation: Bellera CA, Penel N, Ouali M, Bonvalot S, Casali PG, Nielsen OS, Delannes M, Litiere S, Bonnetain F, Dabakuyo TS, Benjamin RS, Blay JY, Bui BN, Collin F, Delaney TF, Duffaud F, Filleron T, Fiore M, Gelderblom H, George S, Grimer R, Grosclaude P, Gronchi A, Haas R, Hohenberger P, Issels R, Italiano A, Jooste V, Krarup-Hansen A, Le Pechoux C, Mussi C, Oberlin O, Patel S, Piperno-Neumann S, Raut C, Ray-Coquard I, Rutkowski P, Schuetze S, Sleijfer S, Stoeckle E, Van Glabbeke M, Woll P, Gourgou-Bourgade S, Mathoulin-Pelissier S. Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)dagger. Ann Oncol. 2015 May;26(5):865-872. doi: 10.1093/annonc/mdu360. Epub 2014 Jul 28.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: Bonnetain F, Bonsing B, Conroy T, Dousseau A, Glimelius B, Haustermans K, Lacaine F, Van Laethem JL, Aparicio T, Aust D, Bassi C, Berger V, Chamorey E, Chibaudel B, Dahan L, De Gramont A, Delpero JR, Dervenis C, Ducreux M, Gal J, Gerber E, Ghaneh P, Hammel P, Hendlisz A, Jooste V, Labianca R, Latouche A, Lutz M, Macarulla T, Malka D, Mauer M, Mitry E, Neoptolemos J, Pessaux P, Sauvanet A, Tabernero J, Taieb J, van Tienhoven G, Gourgou-Bourgade S, Bellera C, Mathoulin-Pelissier S, Collette L. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials). Eur J Cancer. 2014 Nov;50(17):2983-93. doi: 10.1016/j.ejca.2014.07.011. Epub 2014 Sep 22.

ReferenceCitation: Bellera CA, Pulido M, Gourgou S, Collette L, Doussau A, Kramar A, Dabakuyo TS, Ouali M, Auperin A, Filleron T, Fortpied C, Le Tourneau C, Paoletti X, Mauer M, Mathoulin-Pelissier S, Bonnetain F. Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: formal consensus method for the development of guidelines for standardised time-to-event endpoints' definitions in cancer clinical trials. Eur J Cancer. 2013 Mar;49(4):769-81. doi: 10.1016/j.ejca.2012.09.035. Epub 2012 Nov 2.

ReferenceCitation: Gourgou-Bourgade S, Cameron D, Poortmans P, Asselain B, Azria D, Cardoso F, A'Hern R, Bliss J, Bogaerts J, Bonnefoi H, Brain E, Cardoso MJ, Chibaudel B, Coleman R, Cufer T, Dal Lago L, Dalenc F, De Azambuja E, Debled M, Delaloge S, Filleron T, Gligorov J, Gutowski M, Jacot W, Kirkove C, MacGrogan G, Michiels S, Negreiros I, Offersen BV, Penault Llorca F, Pruneri G, Roche H, Russell NS, Schmitt F, Servent V, Thurlimann B, Untch M, van der Hage JA, van Tienhoven G, Wildiers H, Yarnold J, Bonnetain F, Mathoulin-Pelissier S, Bellera C, Dabakuyo-Yonli TS. Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials). Ann Oncol. 2015 Dec;26(12):2505-6. doi: 10.1093/annonc/mdv478. Epub 2015 Oct 13. No abstract available.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Kramar A, Negrier S, Sylvester R, Joniau S, Mulders P, Powles T, Bex A, Bonnetain F, Bossi A, Bracarda S, Bukowski R, Catto J, Choueiri TK, Crabb S, Eisen T, El Demery M, Fitzpatrick J, Flamand V, Goebell PJ, Gravis G, Houede N, Jacqmin D, Kaplan R, Malavaud B, Massard C, Melichar B, Mourey L, Nathan P, Pasquier D, Porta C, Pouessel D, Quinn D, Ravaud A, Rolland F, Schmidinger M, Tombal B, Tosi D, Vauleon E, Volpe A, Wolter P, Escudier B, Filleron T; DATECAN Renal Cancer group. Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN projectdagger. Ann Oncol. 2015 Dec;26(12):2392-8. doi: 10.1093/annonc/mdv380. Epub 2015 Sep 14.

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

ReferenceCitation: Cohen R, Vernerey D, Bellera C, Meurisse A, Henriques J, Paoletti X, Rousseau B, Alberts S, Aparicio T, Boukovinas I, Gill S, Goldberg RM, Grothey A, Hamaguchi T, Iveson T, Kerr R, Labianca R, Lonardi S, Meyerhardt J, Paul J, Punt CJA, Saltz L, Saunders MP, Schmoll HJ, Shah M, Sobrero A, Souglakos I, Taieb J, Takashima A, Wagner AD, Ychou M, Bonnetain F, Gourgou S, Yoshino T, Yothers G, de Gramont A, Shi Q, Andre T; ACCENT Group. Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative. Eur J Cancer. 2020 May;130:63-71. doi: 10.1016/j.ejca.2020.02.009. Epub 2020 Mar 12.

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

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

location_facility:
Institut Bergonié
Centre Georges François Leclerc
Institut du Cancer de Montpellier


title: Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise

acronym: CARDIBOX

summary: The high prevalence of childhood obesity is a major public health issue, worldwide. Childhood obesity is associated with a high risk of cardiovascular events in adulthood, but recent studies also point out the development of cardiovascular complications in childhood or adolescence justifying the need for early detection and appropriate therapeutic management to prevent the development of more severe abnormalities. This project proposes to evaluate the myocardial function in a fine and comprehensive way (longitudinal, circumferential and radial linear deformations, and rotation / torsion mechanics) from the deformation imaging (MRI and high-resolution echocardiography), in obese adolescents following a lifestyle intervention combining diet and physical activity.

study_start_date_type: Anticipated

collaborators: LaPSCo laboratory, Physiological and Psychosocial Stress, UMR CNRS 6024, Clermont-Ferrand, France

collaborators: LaPEC laboratory (EA 4278), University of Avignon, Avignon, France

collaborators: Child Medical Center, 3 Rue de la Prugne, 63540 Romagnat, France

collaborators: Tza-Nou Center, 230 Rue Vercingétorix, 63150 La Bourboule, France


title: BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology

summary:
Diffuse large B-cell lymphomas (DLBCLs) represent 25 to 30% of adult non-Hodgkin lymphomas in western countries. DLBCLs are aggressive cancer but potentially curable with multi-agent chemotherapy. Whereas R-CHOP regimen has led to a marked improvement in survival, this disease remains a biologically heterogeneous entity. New therapeutic strategies are required including identification of patients' subgroups with different prognostic.

This project is based on BMS_LyTrans and Goelams 075 clinical trial. A study of whole blood transcriptome in 75 DLBCL patients and in 87 controls showed that PD-L1 (CD274) gene was overexpressed in DLBCL patients. Preliminary results demonstrated that PD-L1 is detected in plasma of DLBCL patients with a significantly higher concentration than in controls. This protein was selected as a potential biomarker because of its established role in anti-tumoral immunity. Interaction between PD-L1 and its receptor PD-1 is known to inhibit activation of immune responses by inducing T-lymphocytes anergy and/or apoptosis. Moreover, a direct involvement of PD-L1 in the protection of cancer cells from lysis by activated T lymphocytes has been demonstrated. PD-L1 expression has been described in several solid tumours, including ovary cancer, breast cancer, colon cancer, renal cell carcinoma, non-small cell lung carcinoma and in hematological malignancies such as T-NHL, MM and Hodgkin's lymphoma. Furthermore the expression of PD-L1 by tumour cells is associated with poor prognosis. The blockade of PD-L1/PD-1 axis may represent a novel therapeutic approach in aggressive cancers. These first results incite to identify the cells releasing soluble PD-L1 and to investigate its role in the anti-tumoral immunity in DLBCL patients.

The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at diagnosis in comparison to others tumours known to express PD-L1 (metastatic breast cancer, Hodgkin's lymphoma, non-small cell lung cancer).

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
Roche Pharma AG
National Research Agency, France

location_facility:
Rennes EFS
Montpellier University Hospital
Rennes University Hospital
Institut Paoli Calmette


lead_sponsor: Eisai Inc.

summary: This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic drugs.

ReferenceCitation: Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

ReferenceCitation: Auvin S, Williams B, McMurray R, Kumar D, Perdomo C, Malhotra M. Novel seizure outcomes in patients with Lennox-Gastaut syndrome: Post hoc analysis of seizure-free days in rufinamide Study 303. Epilepsia Open. 2019 Mar 13;4(2):275-280. doi: 10.1002/epi4.12314. eCollection 2019 Jun.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Arzimanoglou A, Ferreira J, Satlin A, Olhaye O, Kumar D, Dhadda S, Bibbiani F. Evaluation of long-term safety, tolerability, and behavioral outcomes with adjunctive rufinamide in pediatric patients (>/=1 to <4 years old) with Lennox-Gastaut syndrome: Final results from randomized study 303. Eur J Paediatr Neurol. 2019 Jan;23(1):126-135. doi: 10.1016/j.ejpn.2018.09.010. Epub 2018 Sep 27.

ReferenceCitation: Arzimanoglou A, Ferreira JA, Satlin A, Mendes S, Williams B, Critchley D, Schuck E, Hussein Z, Kumar D, Dhadda S, Bibbiani F. Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study. Eur J Paediatr Neurol. 2016 May;20(3):393-402. doi: 10.1016/j.ejpn.2015.12.015. Epub 2016 Jan 11.

title: A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome

source: euctr

location_country:
Italy
Poland
United States
Greece
South Africa
Canada
France


title: Study of STIM1 Membrane Expression During Autoimmune Diseases

acronym: STIMEX

summary:
The aim of this study is to determine the expression of STIM1 in the plasma membrane of lymphocytes from patients suffering from different autoimmune diseases in order to identify new pathologies of interest presenting an over-expression of STIM1PM.

This would allow to initiate, following this study, research and development programs on the use of anti-STIM1 antibodies in these identified autoimmune diseases of interest.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHU de Martinique
Centre Hospitalier de Quimper
CHRU de Brest - Service de rhumatologie
Centre Hospitalier des Pays de Morlaix


title: Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care: a Retrospective Study in 6 Centers

acronym: PNOrate

summary:
The number of lung biopsies has increased steadily in recent years. Pneumothorax is the most common complication of a lung biopsy and can occur during the procedure, immediately after the procedure or within a few hours (delayed pneumothorax). The incidence of pneumothorax in the literature is very different from one study to another: it has been reported to be from 9 to 54% in patients undergoing percutaneous transthoracic needle biopsy. This difference of incidence could be explained by the absence of consensus for the definition of an iatrogenic pneumothorax.

The characteristics of pneumothorax and the management of patients with iatrogenic pneumothorax will be evaluated in different centres in a retrospective manner. This study will contribute to refining the criteria for defining pneumothorax occurring during lung biopsy and will provide a better understanding of the condition and its management.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_country: Ireland France

location_facility:
Institut Bergonié
Saint James Hospital
CHU de Tours
CHU de Besançon
Institut Gustave Roussy


title: A Phase II Study Evaluating the Interest to Combine UCPVax a CD4 TH1-inducer Cancer Vaccine and Atezolizumab for the Treatment of Human PapillomaVirus Positive Cancers

acronym: VolATIL

summary:
70% all cases of cervical cancer, 95% of anal cancers and about 70% of oropharyngeal cancers are linked to Human Papillomavirus (HPV) infection. HPV oncogenic proteins are trans-activators of telomerase. Indeed, E6 oncoprotein transactivates the human telomerase (hTert). Our group has conducted a clinical trial (NCT02402842) in advanced squamous cell anal cancer (SCCA) and investigators have shown a correlation between the presence of anti-HPV immunity and anti-telomerase T helpher 1 (TH1) CD4 T cell responses, establishing telomerase as an appropriate antigen in HPV-related cancers.

Tumor-reactive CD4+ T cells have been found to ensure efficient effector Cytotoxic T Lymphocytes (CTL) recruitment at the tumor site. Promoting tumor specific TH1 CD4 activation might be an attractive therapeutic option to enhance anti-PD-1/PD-L1 (Programmed cell Death-1/Programmed cell Death-Ligand1) efficacy. However, no option is currently available to expand tumor specific TH1 lymphocytes in most patients. Then, investigators have identified four novel MHC (Major Histocompatibility Complex) class II-restricted peptides derived from human telomerase reverse transcriptase (TERT) referred as "Universal Cancer Peptides" (UCP). UCPVax is a therapeutic cancer vaccine developed by our team and composed of two separate peptides called UCP2 and UCP4 derived from telomerase. This UCPVax vaccine is currently evaluated in a multicenter phase I/II study in Non Small Lung Cancer (NSCLC) (NCT2818426) and seems to show to be safe and immunogenic.

PD-1/PD-L1 immune checkpoint is a relevant candidate target for immunotherapy in HPV+ cancers, based on the prominent role of PD-1 and its ligand PD-L1 in HPV-driven immune-evasion. There is a strong rational of using PD-1 therapy in HPV+ cancers, however anti-PD-1/PD-L1 treatment induces a limited number of long term responses in HPV disease. Combining anti-PD-1/PD-L1 therapy with an antitumor vaccine gains serious consideration in HPV+ cancers. Indeed, anti-cancer vaccines can induce tumor-specific T cells expansion and activation and therefore restore the cancer-immunity cycle in patients lacking pre-existing anti-tumor responses.

So investigators propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer vaccine (UCPVax) with atezolizumab in patients with HPV+ cancers by evaluation of the objective response rate at 4 months according to iRecist criteria.

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

ReferenceCitation: Godet Y, Fabre E, Dosset M, Lamuraglia M, Levionnois E, Ravel P, Benhamouda N, Cazes A, Le Pimpec-Barthes F, Gaugler B, Langlade-Demoyen P, Pivot X, Saas P, Maillere B, Tartour E, Borg C, Adotevi O. Analysis of spontaneous tumor-specific CD4 T-cell immunity in lung cancer using promiscuous HLA-DR telomerase-derived epitopes: potential synergistic effect with chemotherapy response. Clin Cancer Res. 2012 May 15;18(10):2943-53. doi: 10.1158/1078-0432.CCR-11-3185. Epub 2012 Mar 8.

ReferenceCitation: Dosset M, Godet Y, Vauchy C, Beziaud L, Lone YC, Sedlik C, Liard C, Levionnois E, Clerc B, Sandoval F, Daguindau E, Wain-Hobson S, Tartour E, Langlade-Demoyen P, Borg C, Adotevi O. Universal cancer peptide-based therapeutic vaccine breaks tolerance against telomerase and eradicates established tumor. Clin Cancer Res. 2012 Nov 15;18(22):6284-95. doi: 10.1158/1078-0432.CCR-12-0896. Epub 2012 Oct 2.

ReferenceCitation: Dosset M, Vauchy C, Beziaud L, Adotevi O, Godet Y. Universal tumor-reactive helper peptides from telomerase as new tools for anticancer vaccination. Oncoimmunology. 2013 Mar 1;2(3):e23430. doi: 10.4161/onci.23430.

ReferenceCitation: Rebucci-Peixoto M, Vienot A, Adotevi O, Jacquin M, Ghiringhelli F, de la Fouchardiere C, You B, Maurina T, Kalbacher E, Bazan F, Meynard G, Clairet AL, Fagnoni-Legat C, Spehner L, Bouard A, Vernerey D, Meurisse A, Kim S, Borg C, Mansi L. A Phase II Study Evaluating the Interest to Combine UCPVax, a Telomerase CD4 TH1-Inducer Cancer Vaccine, and Atezolizumab for the Treatment of HPV Positive Cancers: VolATIL Study. Front Oncol. 2022 Jul 19;12:957580. doi: 10.3389/fonc.2022.957580. eCollection 2022.

publisher_dissemination: Frontiers

collaborators:
Roche Pharma AG
National Cancer Institute, France

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

location_facility:
Hospices Civils de Lyon
CHU de Besançon
Centre Léon Bérard
Centre Georges François Leclerc