lead_sponsor: LEO Pharma

location_country:
Germany
United Kingdom
France

acronym: Not applicable

location_facility: HOPITAL DE L ARCHET II - Service de Dermatologie-Vénérologie

location_facility: Hôpital d'instruction des Armées Bégin - Clinique Dermatologique

location_facility: CHRU de Brest - Hôpital Morvan - Service de Dermatologie

location_facility: Dermatologisches Zentrum, Am Krankenhaus 1

location_facility: HOPITAL COCHIN TARNIER - Service de Dermatologie

location_facility: Hôpital Saint Louis - Service de Dermatologie

location_facility: CHU de Nantes - Hôtel Dieu - Unité Fonctionnelle de Dermatologie Cancérologie

location_facility: Universitätsklinikum Leipzig Klinik für Dermatologie, Venerologie und Allergologie

location_facility: HOPITAL AVICENNE - Service de Dermatologie

location_facility: Hôpital de la Timone - Service de Dermatologie Vénérologie

location_facility: Klinik für Dermatologie und Allergologie, Klinikum Vest, Behandlungszentrum, Knappschaftskrankenhaus Recklinghausen,

location_facility: CHU Albert Michallon - Service de Dermatologie, Pôle Pluridisciplinaire de Médecine

location_facility: Hauttumorzentrum Bochum Universitätsklinikum der Ruhr-Universität-Bochum

location_facility: Hôpital Claude Huriez - CHRU de Lille - Clinique de Dermatologie

title: A Phase 4 Trial Comparing the Cumulative Incidence of SCC After Treatment With Ingenol Mebutate and Imiquimod for Multiple Actinic Keratoses on Face and Scalp. A Multi-centre, Randomised, Two-arm, Open Label, Active-controlled, Parallel Group, 36-month Trial

summary: The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream. Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive a second treatment cycle with the same treatment if the first treatment does not clear all AKs. Subjects will be followed over a period of three year (36 months) after first treatment


acronym: APNEE REA

summary: Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each center will use the method of apnea test which it uses usually.

status: Completed

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Poitiers University Hospital

location_facility:
Saintes Hospital
Brest University Hospital
Orléans Hospital
Nantes University Hospital
La Roche sur Yon Hospital
La Rochelle Hospital
Angoulême Hospital
Nice University Hospital
Limoges University Hospital
Tours University Hospital
Cochin University Hospital
Rennes University hospital
Toulon University Hospital
Angers University Hospital
Poitiers University Hospital
Sud Francilien Hospital
Bordeaux University Hospital

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Gatault P, Kamar N, Büchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Le Meur Y, Essig M, Bouvier N, Legendre C, Moulin B, Heng AE, Weestel PF, Sayegh J, Charpentier B, Rostaing L, Thervet E, Lebranchu Y. Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study. Am J Transplant. 2017 May;17(5):1370-1379. doi: 10.1111/ajt.14109. Epub 2017 Jan 3.

name: EA4245 Dendritic Cells; Immunomodulation and Grafts; François-Rabelais University; Tours France

name: Department of Nephrology and Clinical Immunology; CHRU Tours; Tours France

family: Gatault

full_name: P. Gatault

given: P.

sequence: first

name: Department of Nephrology and Organ Transplantation; CHU Rangueil; Toulouse France

name: INSERM U1043; IFR-BMT; CHU Purpan; Toulouse France

name: Université Paul Sabatier; Toulouse France

family: Kamar

full_name: N. Kamar

given: N.

sequence: additional

family: Büchler

full_name: M. Büchler

given: M.

name: Department of Kidney Transplantation; CHU Reims; Reims France

family: Colosio

full_name: C. Colosio

given: C.

name: Department of Kidney Transplantation; CHU Rouen; Rouen France

family: Bertrand

full_name: D. Bertrand

given: D.

name: Department of Kidney Transplantation; Kremlin-Bicêtre Hospital; Villejuif France

family: Durrbach

full_name: A. Durrbach

given: A.

name: Department of Kidney Transplantation; CHU Nice; Nice France

family: Albano

full_name: L. Albano

given: L.

name: Department of Kidney Transplantation; CHU Rennes; Rennes France

family: Rivalan

full_name: J. Rivalan

given: J.

name: Department of Kidney Transplantation; CHU Brest; Brest France

family: Le Meur

full_name: Y. Le Meur

given: Y.

name: Department of Kidney Transplantation; CHU Limoges; Limoges France

family: Essig

full_name: M. Essig

name: Department of Kidney Transplantation; CHU Caen; Caen France

family: Bouvier

full_name: N. Bouvier

name: Department of Kidney Transplantation; Necker Hospital; Paris France

family: Legendre

full_name: C. Legendre

name: Department of Kidney Transplantation; CHRU Strasbourg; Strasbourg France

family: Moulin

full_name: B. Moulin

given: B.

name: Department of Kidney Transplantation; CHU Clermont-Ferrand; Clermont-Ferrand France

family: Heng

full_name: A.-E. Heng

name: Department of Kidney Transplantation; CHU Amiens; Amiens France

family: Weestel

full_name: P.-F. Weestel

name: Department of Kidney Transplantation; CHU Angers; Angers France

family: Sayegh

full_name: J. Sayegh

family: Charpentier

full_name: B. Charpentier

family: Rostaing

full_name: L. Rostaing

name: Department of Kidney Transplantation; Georges-Pompidou Hospital; Paris France

family: Thervet

full_name: E. Thervet

given: E.

family: Lebranchu

full_name: Y. Lebranchu

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Transplantation

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

design_allocation: Randomized

intervention_type: Drug

status: Unknown status

study_type: Interventional

lead_sponsor: University Hospital, Tours

primary_purpose: Treatment

location_facility:
CHU de Caen
Hôpital Archet II
Hôpital Necker
Hôpital Bois-Guillaume
CHU de Angers
Hôpital Sud
Hôpital Dupuytren
Hôpital Pontchaillou
Hôpital Gabriel Montpied
Hôpital Civil
HEGP
CHRU de Tours
Hôpital Maison Blanche
Hôpital Bicêtre
Hôpital Cavale Blanche
CHU de Toulouse

title: Efficacy and Safety Outcome of Two Different Targets of Advagraf® Trough Levels Between 4 Months and 12 Months After Transplantation Among de Novo Renal Transplant Recipients.

summary: This prospective, interventional, open label, randomized, multicenter study was designed to determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after transplantation. Randomized patients are to be stable with their tacrolimus daily dose required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual dose. The benefit/risk ratio will include the assessment of renal function, histological lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and infectious diseases).


title: Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.

summary: The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.

study_completion_date_type: Anticipated

ReferenceCitation: Bidard FC, Jacot W, Kiavue N, Dureau S, Kadi A, Brain E, Bachelot T, Bourgeois H, Gonçalves A, Ladoire S, Naman H, Dalenc F, Gligorov J, Espié M, Emile G, Ferrero JM, Loirat D, Frank S, Cabel L, Diéras V, Cayrefourcq L, Simondi C, Berger F, Alix-Panabières C, Pierga JY. Efficacy of Circulating Tumor Cell Count-Driven vs Clinician-Driven First-line Therapy Choice in Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: The STIC CTC Randomized Clinical Trial. JAMA Oncol. 2021 Jan 1;7(1):34-41. doi: 10.1001/jamaoncol.2020.5660.

name: Department of Medical Oncology, Institut Curie, UVSQ and Paris-Saclay University, Saint-Cloud, France

name: INSERM Center of Clinical Investigations in Biotherapies of Cancer (CIC-BT) 1428, Paris, France

family: Bidard

full_name: François-Clément Bidard

given: François-Clément

name: Department of Medical Oncology, Institut du Cancer de Montpellier (ICM), Institut de Recherche en Cancérologie de Montpellier, INSERM U1194, Montpellier University, Montpellier, France

family: Jacot

full_name: William Jacot

given: William

family: Kiavue

full_name: Nicolas Kiavue

given: Nicolas

name: Biometry Unit, Institut Curie, PSL Research University, Paris, France

family: Dureau

full_name: Sylvain Dureau

given: Sylvain

family: Kadi

full_name: Amir Kadi

given: Amir

family: Brain

full_name: Etienne Brain

given: Etienne

name: Department of Medical Oncology, Centre Léon Bérard, Lyon, France

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

name: Department of Medical Oncology, Victor Hugo Clinic, Le Mans, France

family: Bourgeois

full_name: Hugues Bourgeois

given: Hugues

name: Department of Medical Oncology, Institut Paoli-Calmettes, CRCM, Aix-Marseille University, Marseille, France

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

name: Department of Medical Oncology, Centre Georges François Leclerc, Dijon, France

family: Ladoire

full_name: Sylvain Ladoire

name: Department of Medical Oncology, Centre Azuréen de Cancérologie, Mougins, France

family: Naman

full_name: Hervé Naman

given: Hervé

name: Department of Medical Oncology, Institut Claudius Regaud, Toulouse, France

family: Dalenc

full_name: Florence Dalenc

given: Florence

name: Department of Medical Oncology, Hôpital Tenon, Sorbonne Université, Paris, France

family: Gligorov

full_name: Joseph Gligorov

given: Joseph

name: Department of Medical Oncology, Hôpital Saint-Louis, Paris, France

family: Espié

full_name: Marc Espié

given: Marc

name: Department of Medical Oncology, Centre François Baclesse, Caen, France

family: Emile

full_name: George Emile

given: George

name: Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

name: Department of Medical Oncology, Institut Curie, Université de Paris, Paris, France

family: Loirat

full_name: Delphine Loirat

given: Delphine

family: Frank

full_name: Sophie Frank

given: Sophie

family: Cabel

full_name: Luc Cabel

given: Luc

name: Formerly with Department of Medical Oncology, Institut Curie, Paris, France

name: Now with Department of Medical Oncology, Centre Eugène Marquis, Rennes, France

family: Diéras

full_name: Véronique Diéras

given: Véronique

name: Laboratory of Rare Human Circulating Cells, University Medical Center of Montpellier, EA 2415, Montpellier University, Montpellier, France

family: Cayrefourcq

full_name: Laure Cayrefourcq

given: Laure

name: Clinical Research Department, Institut Curie, PSL Research University, Paris, France

family: Simondi

full_name: Cécile Simondi

given: Cécile

family: Berger

full_name: Frédérique Berger

given: Frédérique

family: Alix-Panabières

title: Efficacy of Circulating Tumor Cell Count–Driven vs Clinician-Driven First-line Therapy Choice in Hormone Receptor–Positive, ERBB2-Negative Metastatic Breast Cancer

location_facility: Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: Institut régional du Cancer de Montpellier


type: Other Identifier

title: Evaluation of the VQ11 Auto-questionnaire of Quality of Life in Pneumology Investigation, During the Implementation of a Long-acting Bronchodilator Treatment of Patients With COPD.

acronym: EPIC

summary:
The purpose of this study is to estimate the capacity of the auto-questionnaire of quality of life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days) during the implementation of a LABD (Long-acting bronchodilator) treatment.

The main objective is to compare the total Score of the VQ11 auto-questionnaire before and after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD.

study_completion_date_type: Actual

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Résidence Saint Michel
CHU Amiens Nord
Centre Médical
CH Creil
Clinique de l'Europe
Hopital Jacques MONOD
CHRU de Lille
Centre hospitalier de St Quentin
CHU Amiens Sud
CH de DOUAI
Zac Gouraud
Hopital Maison Blanche
CHU de Rouen
Centre Hospitalier de Compiègne
Centre Hospitalier de Chauny

intervention_type: Other


title: Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess

acronym: APA

summary:
Analyze in children and adults, risk factors in the onset of the APA. The main hypothesis focuses on the use of anti-inflammatory in the context of pharyngitis or sore throat before the symptoms of ABS. Secondary objectives:

- Analyze the implementation of a rapid diagnostic test and its result on the occurrence of an ABS
- Measure the frequency of prescription and describe the reasons for not prescribing an antibiotic for patients who consulted for a sore throat and having developed a PLA
- Describe the microbial flora could puncture of patients hospitalized for APA

status: Terminated

enrollment_type: Anticipated

lead_sponsor: Nantes University Hospital

location_facility:
Angers university Hospital
Paris-Lariboisière Hospital
Ambroise Paré Hospital
Tours University Hosipital
Lille University Hospital
Caen universty Hospital
Grenoble University Hospital
Paris-Bichat-Hospital
Paris-Cochin Hospital
Rennes University hospital
Toulouse University Hospital
Poitiers University Hospital
Nantes University Hospital
Paris-Tenon-Hospital
Clermont Ferrand University Hospital

status_simplified: Unknown


lead_sponsor: Pierre Fabre Medicament

primary_purpose: Basic Science

location_country: Italy Spain France Portugal

acronym: PERMIN

type: EudraCT Number

source: euctr

title: Exploratory Study of L.S.E.S.r. (PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in the Treatment of Urinary Symptoms Related to BPH; a Multinational, Multicentric, Randomised, Double Blind Parallel-group Prospective Study

summary:
Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent published works pointed out that urine and serum markers could be used for detection of prostatic inflammation.

The aim of the study is to assess the activity on inflammation biomarkers (serum and urine inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the treatment of urinary symptoms related to BPH.

The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.

lead_sponsor_type: industriel


title: Prospective Construction and Validation of a Prognostic Score to Identify Among Patients With Metastatic Breast Cancer Those Who Benefit From a Third Line Chemotherapy in Terms of Overall Survival

summary:
This is a biomedical study of interventional type. The trial will include 270 patients (180 patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2 years of follow up.

This prospective study will be conduct in patients who will receive a third line chemotherapy for metastatic breast cancer.

The main objective of the study (first cohort) is to identify patients who benefit from a third line treatment in terms of overall survival with a score established from clinical, histological, but also biological "classic" and "innovative" (account of circulating tumor cells) criteria, all of these criteria must be measurable before the introduction of the 3rd line.

This score will then be validated on the 2nd cohort.

There will be no interruption of inclusions between first and second cohort of patients

study_start_date_type: Actual

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: Institut Claudius Regaud

location_facility: Centre d'Oncologie et de Radiothérapie du Parc

location_facility: Centre Hospitalier Intercommunal de Castres-Mazamet

location_facility: Institut de Cancérologie de l'Ouest Paul Papin

status_simplified: Ongoing


title: Single-blind Randomised Pragmatic Trial Comparing the Effectiveness of Two Hyaluronic Acid Viscosupplements, DUROLANE® (Single Injection) Versus HYALGAN® (Three Injections) for Symptomatic Tibiofemoral Osteoarthritis of the Knee.

summary: The purpose of this study is to assess whether a single injection hyaluronic acid (HA) product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of effectiveness in reducing pain when walking in patients suffering from symptomatic tibiofemoral osteoarthritis of the knee.

ipd_sharing: Undecided

lead_sponsor: Bioventus LLC

location_country: Monaco France

location_facility: Centre Hospitalier de Belfort-Montbeliard

location_facility: Institut de l'Appareil Locomoteur - Nollet

intervention_type: Device


title: Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer : a Multicenter Non-randomized Prospective Cohort Study

acronym: StoRM

summary:
This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer.

1500 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study.

Patients will be treated and followed according to the standards of their treating center.

They will be followed during at least 5 years every 6 months for 3 years then every year.

ReferenceType: background

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ReferenceCitation: Udler M, Pharoah PD. Germline genetic variation and breast cancer survival: prognostic and therapeutic implications. Future Oncol. 2007 Oct;3(5):491-5.

ReferenceCitation: Hemminki K, Ji J, Försti A, Sundquist J, Lenner P. Survival in breast cancer is familial. Breast Cancer Res Treat. 2008 Jul;110(1):177-82. Epub 2007 Aug 3.

ReferenceCitation: Cox A, Dunning AM, Garcia-Closas M, Balasubramanian S, Reed MW, Pooley KA, Scollen S, Baynes C, Ponder BA, Chanock S, Lissowska J, Brinton L, Peplonska B, Southey MC, Hopper JL, McCredie MR, Giles GG, Fletcher O, Johnson N, dos Santos Silva I, Gibson L, Bojesen SE, Nordestgaard BG, Axelsson CK, Torres D, Hamann U, Justenhoven C, Brauch H, Chang-Claude J, Kropp S, Risch A, Wang-Gohrke S, Schürmann P, Bogdanova N, Dörk T, Fagerholm R, Aaltonen K, Blomqvist C, Nevanlinna H, Seal S, Renwick A, Stratton MR, Rahman N, Sangrajrang S, Hughes D, Odefrey F, Brennan P, Spurdle AB, Chenevix-Trench G; Kathleen Cunningham Foundation Consortium for Research into Familial Breast Cancer, Beesley J, Mannermaa A, Hartikainen J, Kataja V, Kosma VM, Couch FJ, Olson JE, Goode EL, Broeks A, Schmidt MK, Hogervorst FB, Van't Veer LJ, Kang D, Yoo KY, Noh DY, Ahn SH, Wedrén S, Hall P, Low YL, Liu J, Milne RL, Ribas G, Gonzalez-Neira A, Benitez J, Sigurdson AJ, Stredrick DL, Alexander BH, Struewing JP, Pharoah PD, Easton DF; Breast Cancer Association Consortium. A common coding variant in CASP8 is associated with breast cancer risk. Nat Genet. 2007 Mar;39(3):352-8. Epub 2007 Feb 11. Erratum in: Nat Genet. 2007 May;39(5):688.

ReferenceCitation: Thomas G, Jacobs KB, Kraft P, Yeager M, Wacholder S, Cox DG, Hankinson SE, Hutchinson A, Wang Z, Yu K, Chatterjee N, Garcia-Closas M, Gonzalez-Bosquet J, Prokunina-Olsson L, Orr N, Willett WC, Colditz GA, Ziegler RG, Berg CD, Buys SS, McCarty CA, Feigelson HS, Calle EE, Thun MJ, Diver R, Prentice R, Jackson R, Kooperberg C, Chlebowski R, Lissowska J, Peplonska B, Brinton LA, Sigurdson A, Doody M, Bhatti P, Alexander BH, Buring J, Lee IM, Vatten LJ, Hveem K, Kumle M, Hayes RB, Tucker M, Gerhard DS, Fraumeni JF Jr, Hoover RN, Chanock SJ, Hunter DJ. A multistage genome-wide association study in breast cancer identifies two new risk alleles at 1p11.2 and 14q24.1 (RAD51L1). Nat Genet. 2009 May;41(5):579-84. doi: 10.1038/ng.353. Epub 2009 Mar 29.

ReferenceCitation: Lander ES, Linton LM, Birren B, Nusbaum C, Zody MC, Baldwin J, Devon K, Dewar K, Doyle M, FitzHugh W, Funke R, Gage D, Harris K, Heaford A, Howland J, Kann L, Lehoczky J, LeVine R, McEwan P, McKernan K, Meldrim J, Mesirov JP, Miranda C, Morris W, Naylor J, Raymond C, Rosetti M, Santos R, Sheridan A, Sougnez C, Stange-Thomann Y, Stojanovic N, Subramanian A, Wyman D, Rogers J, Sulston J, Ainscough R, Beck S, Bentley D, Burton J, Clee C, Carter N, Coulson A, Deadman R, Deloukas P, Dunham A, Dunham I, Durbin R, French L, Grafham D, Gregory S, Hubbard T, Humphray S, Hunt A, Jones M, Lloyd C, McMurray A, Matthews L, Mercer S, Milne S, Mullikin JC, Mungall A, Plumb R, Ross M, Shownkeen R, Sims S, Waterston RH, Wilson RK, Hillier LW, McPherson JD, Marra MA, Mardis ER, Fulton LA, Chinwalla AT, Pepin KH, Gish WR, Chissoe SL, Wendl MC, Delehaunty KD, Miner TL, Delehaunty A, Kramer JB, Cook LL, Fulton RS, Johnson DL, Minx PJ, Clifton SW, Hawkins T, Branscomb E, Predki P, Richardson P, Wenning S, Slezak T, Doggett N, Cheng JF, Olsen A, Lucas S, Elkin C, Uberbacher E, Frazier M, Gibbs RA, Muzny DM, Scherer SE, Bouck JB, Sodergren EJ, Worley KC, Rives CM, Gorrell JH, Metzker ML, Naylor SL, Kucherlapati RS, Nelson DL, Weinstock GM, Sakaki Y, Fujiyama A, Hattori M, Yada T, Toyoda A, Itoh T, Kawagoe C, Watanabe H, Totoki Y, Taylor T, Weissenbach J, Heilig R, Saurin W, Artiguenave F, Brottier P, Bruls T, Pelletier E, Robert C, Wincker P, Smith DR, Doucette-Stamm L, Rubenfield M, Weinstock K, Lee HM, Dubois J, Rosenthal A, Platzer M, Nyakatura G, Taudien S, Rump A, Yang H, Yu J, Wang J, Huang G, Gu J, Hood L, Rowen L, Madan A, Qin S, Davis RW, Federspiel NA, Abola AP, Proctor MJ, Myers RM, Schmutz J, Dickson M, Grimwood J, Cox DR, Olson MV, Kaul R, Raymond C, Shimizu N, Kawasaki K, Minoshima S, Evans GA, Athanasiou M, Schultz R, Roe BA, Chen F, Pan H, Ramser J, Lehrach H, Reinhardt R, McCombie WR, de la Bastide M, Dedhia N, Blöcker H, Hornischer K, Nordsiek G, Agarwala R, Aravind L, Bailey JA, Bateman A, Batzoglou S, Birney E, Bork P, Brown DG, Burge CB, Cerutti L, Chen HC, Church D, Clamp M, Copley RR, Doerks T, Eddy SR, Eichler EE, Furey TS, Galagan J, Gilbert JG, Harmon C, Hayashizaki Y, Haussler D, Hermjakob H, Hokamp K, Jang W, Johnson LS, Jones TA, Kasif S, Kaspryzk A, Kennedy S, Kent WJ, Kitts P, Koonin EV, Korf I, Kulp D, Lancet D, Lowe TM, McLysaght A, Mikkelsen T, Moran JV, Mulder N, Pollara VJ, Ponting CP, Schuler G, Schultz J, Slater G, Smit AF, Stupka E, Szustakowki J, Thierry-Mieg D, Thierry-Mieg J, Wagner L, Wallis J, Wheeler R, Williams A, Wolf YI, Wolfe KH, Yang SP, Yeh RF, Collins F, Guyer MS, Peterson J, Felsenfeld A, Wetterstrand KA, Patrinos A, Morgan MJ, de Jong P, Catanese JJ, Osoegawa K, Shizuya H, Choi S, Chen YJ, Szustakowki J; International Human Genome Sequencing Consortium. Initial sequencing and analysis of the human genome. Nature. 2001 Feb 15;409(6822):860-921. Erratum in: Nature 2001 Aug 2;412(6846):565. Nature 2001 Jun 7;411(6838):720. Szustakowki, J [corrected to Szustakowski, J].

ReferenceCitation: Olivier M, Aggarwal A, Allen J, Almendras AA, Bajorek ES, Beasley EM, Brady SD, Bushard JM, Bustos VI, Chu A, Chung TR, De Witte A, Denys ME, Dominguez R, Fang NY, Foster BD, Freudenberg RW, Hadley D, Hamilton LR, Jeffrey TJ, Kelly L, Lazzeroni L, Levy MR, Lewis SC, Liu X, Lopez FJ, Louie B, Marquis JP, Martinez RA, Matsuura MK, Misherghi NS, Norton JA, Olshen A, Perkins SM, Perou AJ, Piercy C, Piercy M, Qin F, Reif T, Sheppard K, Shokoohi V, Smick GA, Sun WL, Stewart EA, Fernando J, Tejeda, Tran NM, Trejo T, Vo NT, Yan SC, Zierten DL, Zhao S, Sachidanandam R, Trask BJ, Myers RM, Cox DR. A high-resolution radiation hybrid map of the human genome draft sequence. Science. 2001 Feb 16;291(5507):1298-302.

ReferenceCitation: Azzato EM, Pharoah PD, Harrington P, Easton DF, Greenberg D, Caporaso NE, Chanock SJ, Hoover RN, Thomas G, Hunter DJ, Kraft P. A genome-wide association study of prognosis in breast cancer. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1140-3. doi: 10.1158/1055-9965.EPI-10-0085. Epub 2010 Mar 23.

ReferenceCitation: Purcell S, Neale B, Todd-Brown K, Thomas L, Ferreira MA, Bender D, Maller J, Sklar P, de Bakker PI, Daly MJ, Sham PC. PLINK: a tool set for whole-genome association and population-based linkage analyses. Am J Hum Genet. 2007 Sep;81(3):559-75. Epub 2007 Jul 25.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Antoine Lacassagne
Centre Léon Bérard
Centre François Baclesse
Centre Alexis Vautrin
Hôpital Dupuytren
Hôpital Jean Minjoz - CHU Besançon
Centre Georges François Leclerc
Institut Jean Godinot
Centre Paul Strauss
Institut Claudius Regaud
Institut Paoli Calmettes
Val d'Aurelle
Institut Curie
Centre René Gauducheau
Institut Bergonié
Institut Daniel Hollard
Institut Gustave Roussy


title: An Exploratory Study of Brain Imaging Biomarkers in Patients With Alzheimer's Pathology Receiving Standard of Care

summary: This study will investigate the volume, function and composition of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning technology in participants with memory complaints or early signs of Alzheimer's pathology.

lead_sponsor: Eli Lilly and Company

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


ReferenceCitation: Pautier P, Penel N, Ray-Coquard I, Italiano A, Bompas E, Delcambre C, Bay JO, Bertucci F, Delaye J, Chevreau C, Cupissol D, Bozec L, Eymard JC, Saada E, Isambert N, Guillemet C, Rios M, Piperno-Neumann S, Chenuc G, Duffaud F. A phase II of gemcitabine combined with pazopanib followed by pazopanib maintenance, as second-line treatment in patients with advanced leiomyosarcomas: A unicancer French Sarcoma Group study (LMS03 study). Eur J Cancer. 2020 Jan;125:31-37. doi: 10.1016/j.ejca.2019.10.028. Epub 2019 Dec 10.

family: Pautier

full_name: P. Pautier

given: P.

family: Penel

full_name: N. Penel

given: N.

family: Ray-Coquard

full_name: I. Ray-Coquard

given: I.

family: Italiano

full_name: A. Italiano

given: A.

family: Bompas

full_name: E. Bompas

given: E.

family: Delcambre

full_name: C. Delcambre

given: C.

family: Bay

full_name: J.-O. Bay

family: Bertucci

full_name: F. Bertucci

given: F.

family: Delaye

full_name: J. Delaye

given: J.

family: Chevreau

full_name: C. Chevreau

family: Cupissol

full_name: D. Cupissol

given: D.

family: Bozec

full_name: L. Bozec

given: L.

family: Eymard

full_name: J.-C. Eymard

family: Saada

full_name: E. Saada

family: Isambert

full_name: N. Isambert

family: Guillemet

full_name: C. Guillemet

family: Rios

full_name: M. Rios

given: M.

family: Piperno-Neumann

full_name: S. Piperno-Neumann

given: S.

family: Chenuc

full_name: G. Chenuc

given: G.

family: Duffaud

full_name: F. Duffaud

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing_description: PD will not be shared at an individual level, they will be part of the study database including all enrolled patients

lead_sponsor: UNICANCER

location_facility: Institut Curie - Hôpital Claudius Regaud

location_facility: Institut de Cancérologie de l'Ouest/Centre René Gauducheau

ipd_sharing: No

title: Phase II Multicenter Study to Determine the Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas

summary: The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine.


title: An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma

summary: This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in treatment-naive patients with non-bulky follicular non-Hodgkin's lymphoma. The anticipated time on study treatment is 3 months.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche


title: Endovascular Versus Open Repair of the Common Femoral Artery: a Randomized Trial (TECCO)

acronym: TECCO

summary: Even though the indication for endovascular therapy has been enlarged, open repair of common femoral artery is still considered as the treatment of choice. A recent pilot study showed that endovascular repair of the CFA seems to be a safe technique of revascularization with acceptable initial results at 12 months (Azema et al, Eur J Vasc Endovasc Surg, 2011, in press). TECCO, a French randomized and controlled trial, has been set up to compare open and endovascular procedures for the treatment of CFA atherosclerotic lesions.

ReferenceCitation: Gouëffic Y, Della Schiava N, Thaveau F, Rosset E, Favre JP, Salomon du Mont L, Alsac JM, Hassen-Khodja R, Reix T, Allaire E, Ducasse E, Soler R, Guyomarc'h B, Nasr B. Stenting or Surgery for De Novo Common Femoral Artery Stenosis. JACC Cardiovasc Interv. 2017 Jul 10;10(13):1344-1354. doi: 10.1016/j.jcin.2017.03.046.

family: Gouëffic

full_name: Yann Gouëffic

given: Yann

family: Della Schiava

full_name: Nellie Della Schiava

given: Nellie

family: Thaveau

full_name: Fabien Thaveau

given: Fabien

family: Rosset

full_name: Eugenio Rosset

given: Eugenio

family: Favre

full_name: Jean-Pierre Favre

given: Jean-Pierre

family: Salomon du Mont

full_name: Lucie Salomon du Mont

given: Lucie

family: Alsac

full_name: Jean-Marc Alsac

given: Jean-Marc

family: Hassen-Khodja

full_name: Réda Hassen-Khodja

given: Réda

family: Reix

full_name: Thierry Reix

given: Thierry

family: Allaire

full_name: Eric Allaire

given: Eric

family: Ducasse

full_name: Eric Ducasse

family: Soler

full_name: Raphael Soler

given: Raphael

family: Guyomarc’h

full_name: Béatrice Guyomarc’h

given: Béatrice

family: Nasr

full_name: Bahaa Nasr

given: Bahaa

journal_name: JACC: Cardiovascular Interventions

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_facility:
Tonkin Clinic
University Hospital, HEGP
NCN Clinic
University Hospital, Henri Mondor
St Augustin Clinic
University Hospital


title: Evaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale Prospective

acronym: ZOMAJET

summary:
The purpose of this strictly observational, prospective, longitudinal study is to evaluate with sufficient precision the rate of overall treatment compliance from one year to 3 years of follow-up of the patients.

Somatotropin is indicated in the long-term treatment of children with growth retardation related to a deficiency in secretion of growth hormone and in the long-term treatment of growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are the two indications of Zomacton® 4 mg and 10 mg injection solution.

The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous transjection (needle-free) and can be used by the child directly or by the family after an initial training.

In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the compliance and duration of use of the device.

The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90 patients will be treated. In the cohort studied the patients will be followed-up for 1 year at least and for 3 years at the maximum.

The rate of treatment compliance will be evaluated according to the ratio of the actual duration of administration over the total duration recommended by the physician during the observation period.

lead_sponsor: Ferring Pharmaceuticals


title: Phase II Randomized Trial to Evaluate Two Strategies: Continuing Versus Intermittent (Drug-holiday) Trabectedin-regimen in Patients With Advanced Soft Tissue Sarcoma Experiencing Response or Stable Disease After the Sixth Cycle

acronym: T-DIS

summary:
This randomization discontinuation trial will allow for concomitant evaluation of the following:

Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle
Side effects and benefits of a drug holiday

ReferenceCitation: Le Cesne A, Blay JY, Domont J, Tresch-Bruneel E, Chevreau C, Bertucci F, Delcambre C, Saada-Bouzid E, Piperno-Neumann S, Bay JO, Mir O, Ray-Coquard I, Ryckewaert T, Valentin T, Isambert N, Italiano A, Clisant S, Penel N. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol. 2015 Mar;16(3):312-9. doi: 10.1016/S1470-2045(15)70031-8. Epub 2015 Feb 11.

family: Cesne

full_name: Axel Le Cesne

given: Axel Le

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Domont

full_name: Julien Domont

given: Julien

family: Tresch-Bruneel

full_name: Emmanuelle Tresch-Bruneel

given: Emmanuelle

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Bertucci

full_name: François Bertucci

given: François

family: Delcambre

full_name: Corinne Delcambre

given: Corinne

family: Saada-Bouzid

full_name: Esma Saada-Bouzid

given: Esma

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

given: Sophie

family: Bay

full_name: Jacques-Olivier Bay

given: Jacques-Olivier

family: Mir

full_name: Olivier Mir

given: Olivier

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Ryckewaert

full_name: Thomas Ryckewaert

given: Thomas

family: Valentin

full_name: Thibaud Valentin

given: Thibaud

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Clisant

full_name: Stéphanie Clisant

given: Stéphanie

family: Penel

full_name: Nicolas Penel

journal_name: The Lancet Oncology

lead_sponsor: Centre Oscar Lambret

location_facility:
Paoli Calmette Institute
CHU Timone Adultes
Centre Antoine Lacassagne
Centre Léon Bérard
Centre François Baclesse
Centre Oscar Lambret
Centre Georges François Leclerc
Saint-Jacques Hospital
Centre Jean Perrin
Léon Bérard Center
Centre René Huguenin
Institut Claudius Regaud
Institut Curie
Institut Bergonié
Centre Henri Becquerel
Institut Gustave Roussy


title: An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer

summary: This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.


title: A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer

summary: Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).

lead_sponsor: ARCAGY/ GINECO GROUP

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


title: Study of Psychological and Addictive Profile of Patients With Buerger's Disease

acronym: ADDICTAO

summary:
Background: Buerger's disease (thromboangiitis obliterans or TAO) is a rare disease (1/ 10 000) characterized by the development of segmental thrombotic occlusions of the medium and small arteries of the extremities. Afflicted patients are mostly young, male, inveterate tobacco (or cannabis) smokers who present with distal extremity ischemia, ischemic ulcers, of the toes or fingers. Large arteries are typically spared, as are the coronary, cerebral, and visceral circulations. Patients with TAO often suffer from severe ischemic pain and tissue loss culminating in minor and major limb amputation. Clinical diagnostic criteria generally include history of tobacco abuse; age of onset less than 50 years; infrapopliteal, segmental arterial occlusions with sparing of the proximal vasculature; frequent distal upper extremity arterial involvement (Raynaud's syndrome or digital ulceration); superficial phlebitis; and exclusion of arteriosclerosis, diabetes, true arteritis, proximal embolic source, and hypercoagulable states.

While the cause of Buerger's disease remains unknown, the disease onset and clinical course are inextricably linked to tobacco (or cannabis) abuse. Tobacco abstinence generally results in disease quiescence and remains the mainstay of treatment. For some unknown reason, clinicians observed that TAO patients rarely discontinue smoking even though amputation is usually the inevitable consequence and the only method available of controlling pain and ulceration. Few studies were realized and Hofer-Mayer and coll. found remarkable personality features comparing to coronary patients: TAO patients significantly changed their place of work more often, had more absenteeism from work, smoked more before the illness and continued to smoke more frequently during their illness, were more often single or divorced and had more conflicts in their relationships. Those facts led us to explore their psychopathology and their addictive profile.

Purpose: Search the prevalence of personality disorders in Buerger's patients who present with tobacco or cannabis smoking.

Hypothesis: Patients with Buerger's disease show remarkable personality features (psychological and addictive profile) which are vulnerability factors to stop smoking (tobacco or cannabis) compared to patients with atheromatous arteritis.

lead_sponsor: University Hospital, Lille

location_facility: Georges Pompidou European Hospital, Paris


title: Oligogenic Determinism of Colorectal Cancer

acronym: DOCC

summary:
The majority of the clinical situations suggestive of an increased genetic risk for colorectal cancer (CRC) are not explained by a simple monogenic model. Our working hypothesis is that a fraction of clinical conditions suggestive of an increased genetic risk for CRC (familial aggregation, early age of tumour onset, development of multiple primary CRC) is due to the combination of a limited number of genetic variations, each conferring a moderate risk for CRC, but whose combination results into high risk.

This study, which will be both retrospective and prospective, is an association study that will compare frequencies of selected genetic variations, alone or in combination, between patients (cases) whose clinical presentation is suggestive of an increased genetic risk but who do not present a known Mendelian form of CRC, and controls, in order to assess associations of these variations with non-Mendelian genetic forms of CRC. The inclusion criteria will be: CRC in two first degree relatives, one being diagnosed before 61 years of age; or CRC diagnosed before 51 years of age or advanced colorectal adenoma before 41 years of age; or multiple primary CRCs in the same individual, the first being diagnosed before 61 years of age The exclusion criteria will be: Lynch syndrome, adenomatous polyposis and hamartomatous polyposis. The genetic variations which will be analyzed will include (i) SNPs detected by GWAS and associated to CRC. (ii) Risk factors corresponding to functional polymorphisms within candidate genes. (iii) Imbalance of the TGFbR1 allelic expression. Sample sizes were calculated to obtain 80% power for an odds ratio of 2.5 since the aim of this study is to determine genetic variations conferring a moderate risk. In order to cover all these possibilities and to have reasonable even for the genetic variations with low frequency below 0.03 or high frequency above 0.90, the target sample size was set at 700 cases and 350 controls. The recruitment of patients will be performed at the national level by the cancer genetics departments ensuring a correct evaluation of the personal and familial history and the French molecular diagnosis laboratories network ensuring in routine the analysis of the main genes involved in CRC. The control population will be composed of healthy subjects of Caucasian origin between 45 and 60 years of age, without personal or familial history among their first-degree relatives of colorectal tumours.

Demonstration that the combination of a limited number of genetic variations, each conferring a moderate risk for CRC, results into high risk would allow to base, in selected families, the evaluation of risk in relatives and indication of colonoscopy on the analysis of gene variants the combination of which would confer a high risk. This study will confirm or invalidate the contribution of aTGFbR1 allelic expression imbalance in the determinism of early-onset CRC and familial aggregation of CRC. The demonstration of the involvement in CRC genetic variations with strong effect of specific combinations should be of interest for our general understanding of the molecular basis of CRC.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Rouen

location_facility:
Centre Eugène Marquis
CLCC Val d'Aurelle
UHRouen
Centre François Baclesse
Hôpital Européen Georges Pompidou
CHU de Dijon
CHU de Saint-Etienne
CHRU de Lille
CHU de Montpellier
Institut Claudius Regaud
CHU de Grenoble
Institut Curie
CH de Niort
CHU de Toulouse
Institut Gustave Roussy
CHU de Rennes

intervention_type: Genetic


title: XERAD: Open-Label, Phase II, Randomized, Comparative, Multicentre Trial of Concurrent Whole Brain Radiation Therapy (WBRT) and Capecitabine (Xeloda®) Followed by Maintenance Capecitabine Compared With Standard WBRT in Breast Cancer Patients With Newly Diagnosed Brain Metastasis

acronym: XERAD

summary: This open-label, randomized, parallel arm study will evaluate the effect of capecitabine administered concurrently with WBRT and as maintenance therapy in participants with breast cancer and newly diagnosed brain metastases. Participants will be randomized to receive either capecitabine with 10 days standard WBRT, or WBRT alone. Maintenance therapy will follow with capecitabine or another systemic therapy in the WBRT only group.

intervention_type: Radiation


ReferenceCitation: Schwarz T et al. Co-administration of AS04-adjuvanted HPV-16/18 cervical cancer vaccine with DTPA-IPV in 10-18 year old girls: Month 7 results from a randomized trial. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

ReferenceCitation: Garcia-Sicilia J, Schwarz TF, Carmona A, Peters K, Malkin JE, Tran PM, Behre U, Iturbe EB, Catteau G, Thomas F, Dobbelaere K, Descamps D, Dubin G; HPV Vaccine Adolescent Study Investigators Network. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine coadministered with combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine to girls and young women. J Adolesc Health. 2010 Feb;46(2):142-51. doi: 10.1016/j.jadohealth.2009.11.205.

family: Garcia-Sicilia

full_name: José Garcia-Sicilia

given: José

family: Schwarz

full_name: Tino F. Schwarz

given: Tino F.

family: Carmona

full_name: Alfonso Carmona

given: Alfonso

family: Peters

full_name: Klaus Peters

given: Klaus

family: Malkin

full_name: Jean-Elie Malkin

given: Jean-Elie

family: Tran

full_name: Phu M. Tran

given: Phu M.

family: Behre

full_name: Ulrich Behre

given: Ulrich

family: Iturbe

full_name: Enrique B. Iturbe

given: Enrique B.

family: Catteau

full_name: Gregory Catteau

given: Gregory

family: Thomas

full_name: Florence Thomas

given: Florence

family: Dobbelaere

full_name: Kurt Dobbelaere

given: Kurt

family: Descamps

full_name: Dominique Descamps

given: Dominique

family: Dubin

full_name: Gary Dubin

given: Gary

bso_classification: Social sciences

journal_name: Journal of Adolescent Health

title: Immunogenicity and Safety of Human Papillomavirus-16/18 AS04-Adjuvanted Cervical Cancer Vaccine Coadministered With Combined Diphtheria-Tetanus-Acellular Pertussis–inactivated Poliovirus Vaccine to Girls and Young Women

intervention_type: Biological

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

lead_sponsor: GlaxoSmithKline

primary_purpose: Prevention

location_country: Germany France Spain

ipd_sharing: Yes

title: A Multicentre Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) Co-administered With Boostrix Polio (dTpa-IPV) in Healthy Female Subjects Aged 10-18 Years

summary:
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals' (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either vaccine alone.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


type: Registry Identifier

title: Phase II Randomized Study of First-Line Therapy Comprising Bevacizumab and Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil (FOLFIRI) Versus Bevacizumab and Irinotecan Hydrochloride and Capecitabine (XELIRI) in Patients With Unresectable Metastatic Colorectal Cancer [ACCORD]

summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with bevacizumab in treating patients with colorectal cancer.

PURPOSE: This randomized phase II trial is studying bevacizumab to compare how well it works when given together with two different combination chemotherapy regimens as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

ReferenceType: result

ReferenceCitation: Malka D, Boige V, Jacques N, Vimond N, Adenis A, Boucher E, Pierga JY, Conroy T, Chauffert B, François E, Guichard P, Galais MP, Cvitkovic F, Ducreux M, Farace F. Clinical value of circulating endothelial cell levels in metastatic colorectal cancer patients treated with first-line chemotherapy and bevacizumab. Ann Oncol. 2012 Apr;23(4):919-27. doi: 10.1093/annonc/mdr365. Epub 2011 Aug 8.

family: Malka

full_name: D. Malka

given: D.

family: Boige

full_name: V. Boige

given: V.

family: Jacques

full_name: N. Jacques

given: N.

family: Vimond

full_name: N. Vimond

family: Adenis

full_name: A. Adenis

given: A.

family: Boucher

full_name: E. Boucher

given: E.

family: Pierga

full_name: J.Y. Pierga

family: Conroy

full_name: T. Conroy

given: T.

family: Chauffert

full_name: B. Chauffert

given: B.

family: François

full_name: E. François

family: Guichard

full_name: P. Guichard

given: P.

family: Galais

full_name: M.P. Galais

family: Cvitkovic

full_name: F. Cvitkovic

given: F.

family: Ducreux

full_name: M. Ducreux

given: M.

family: Farace

full_name: F. Farace

journal_name: Annals of Oncology

ReferenceCitation: Antoun S, Bayar MA, Dyevre V, Lanoy E, Smolenschi C, Ducreux M. No evidence for changes in skeletal muscle mass or weight during first-line chemotherapy for metastatic colorectal cancer. BMC Cancer. 2019 Aug 28;19(1):847. doi: 10.1186/s12885-019-6086-2.

family: Antoun

full_name: Sami Antoun

given: Sami

family: Bayar

full_name: Mohamed Amine Bayar

given: Mohamed Amine

family: Dyevre

full_name: Valérie Dyevre

given: Valérie

family: Lanoy

full_name: Emilie Lanoy

given: Emilie

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

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

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

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

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


title: Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes

summary: We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Centre Hospitalier Universitaire de STRASBOURG


title: BRD 06/2-D (Quidam) "Evaluation of the Interest of Oral Hydroquinidine Administration to Treat Patients With Brugada Syndrome, High Cardiac Arrhythmic Risk and Implanted With an Implantable Cardioverter Defibrillator"

acronym: Quidam

summary: The specific aim of this study is to determine whether hydroquinidine administration can prevent heart from appearance of ventricular arrhythmia detected by the automatic implantable defibrillator (ICD).

location_facility:
CHU Angers
CHRU Lille
CHU Rennes
CHU Strasbourg
CHU Toulouse
AP-HM Marseille
CHU Poitiers
AP-HP Paris Lariboisière
CHU Lyon
CHU Bordeaux
CHU Montpellier
CHU Tours
CHU Grenoble
CHU Nantes
CHU Nancy
CHU Brest
CHU Amiens


title: Phase II Randomized Study Evaluting the Effect of Celecoxib as Maintenance Treatment of Stage IIIb Non-Small Cell Lung Cancer That Reponded or is Stable After Radiochemotherapy

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving celecoxib after radiation therapy and chemotherapy may kill any tumor cells that remain after radiation therapy and chemotherapy. Sometimes, after radiation therapy and chemotherapy, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to observation in treating patients who have undergone radiation therapy and chemotherapy for stage II or stage III non-small cell lung cancer.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Medical de Forcilles Hopital Prive

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron


title: Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.

PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.

location_facility:
Polyclinique des Quatre Pavillons
Polyclinique De Courlancy
Hopital Louis Pasteur - Le Coudray
Centre Hospitalier de Dreux
C.H. Senlis
Hopital Saint Antoine
Hopital Drevon
Centre Hospitalier Lyon Sud
Centre Hospitalier Departemental
C.H.G. Beauvais
Hopital Tenon
Hopital Duffaut
Clinique Saint Jean
Hopital Saint - Louis
Clinique Victor Hugo


title: Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life.

acronym: QUALICIS

summary: The aim of this study is to evaluate the role of cognitive disorders and quality of life in patients with CIS, considered as high risk to develop an MS, treated with interferon Beta. This prospective observational study will include 120 patients, all treated and evaluated annually with neurological extensive examination, ophthalmologic screening (OCT, OF, VEP, VF), auto questionnaire about fatigue (musicol, ELIF), quality of life (SEP-59), and conventional MRI.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Montpellier-Nîmes - Hôpital Caremeau


title: A Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant

summary: This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


title: Genetic Linkage in Amyotrophic Lateral Sclerosis and Frontotemporal Dementia

summary:
Amyotrophic lateral sclerosis (ALS) with frontotemporal dementia (FTD) is a rare clinical entity, in which both disorders are variably associated in the same patient or within the family. This adult-onset disorder, which is rapidly fatal, occurs in some families with autosomal dominant (AD) transmission and age-dependant penetrance. Two studies have provided evidence for linkage of this condition to chromosomes 15 (in a single family) and 9 (in five families). However, none of these loci have been yet confirmed. Through a national network of 10 centres with specialists for FTD and/or ALS, we have identified 35 probands with ALS-FTD, including 13 with a family history consistent with AD inheritance.

Mutations in the SOD1 and tau genes, respectively responsible for autosomal dominant forms of ALS and FTD, will be excluded by direct sequencing. We will then extend the pedigree of the 13 autosomal dominant families to all consenting first, second and eventually third degree relatives, using well defined criteria for FTD and ALS. The same strategy will be applied to newly identified families during the course of the project (at least, seven families with AD inheritance expected). Linkage studies will be performed in the 20 families using markers from the two candidate regions on chromosomes 9 and 15. Then, refinement of the candidate region will be obtained by analyzing the linked families with a high density of microsatellite markers. This should lead to the refinement of the candidate regions, allowing to search for mutations in candidate genes. Genes located within the critical regions will be prioritized for their analysis by sequencing, according to their expression in the nervous system and to their function.

Once the responsible gene(s) will be identified, it will then possible to define its spectrum of mutations and to establish genotype/phenotype correlations. Alternatively, if none of the candidate regions is confirmed, a genome wide search will be performed, allowing to identify one or more loci for ALS-FTD. The same strategy would then be applied to identify the corresponding gene(s). This project should contribute for identifying the molecular basis of this devastating disorder with practical consequences for genetic counselling in ALS-FTD families, and with the perspective of elucidating the pathophysiology of this disorder.

time_perspective: Retrospective

ReferenceCitation: Le Ber I, Guedj E, Gabelle A, Verpillat P, Volteau M, Thomas-Anterion C, Decousus M, Hannequin D, Véra P, Lacomblez L, Camuzat A, Didic M, Puel M, Lotterie JA, Golfier V, Bernard AM, Vercelletto M, Magne C, Sellal F, Namer I, Michel BF, Pasquier J, Salachas F, Bochet J; French research network on FTD/FTD-MND, Brice A, Habert MO, Dubois B. Demographic, neurological and behavioural characteristics and brain perfusion SPECT in frontal variant of frontotemporal dementia. Brain. 2006 Nov;129(Pt 11):3051-65.

ReferenceCitation: van der Zee J, Le Ber I, Maurer-Stroh S, Engelborghs S, Gijselinck I, Camuzat A, Brouwers N, Vandenberghe R, Sleegers K, Hannequin D, Dermaut B, Schymkowitz J, Campion D, Santens P, Martin JJ, Lacomblez L, De Pooter T, Peeters K, Mattheijssens M, Vercelletto M, Van den Broeck M, Cruts M, De Deyn PP, Rousseau F, Brice A, Van Broeckhoven C. Mutations other than null mutations producing a pathogenic loss of progranulin in frontotemporal dementia. Hum Mutat. 2007 Apr;28(4):416.

ReferenceCitation: Le Ber I, van der Zee J, Hannequin D, Gijselinck I, Campion D, Puel M, Laquerrière A, De Pooter T, Camuzat A, Van den Broeck M, Dubois B, Sellal F, Lacomblez L, Vercelletto M, Thomas-Antérion C, Michel BF, Golfier V, Didic M, Salachas F, Duyckaerts C, Cruts M, Verpillat P, Van Broeckhoven C, Brice A; French Research Network on FTD/FTD-MND. Progranulin null mutations in both sporadic and familial frontotemporal dementia. Hum Mutat. 2007 Sep;28(9):846-55.

ReferenceCitation: Guedj E, Le Ber I, Lacomblez L, Dubois B, Verpillat P, Didic M, Salachas F, Vera P, Hannequin D, Lotterie JA, Puel M, Decousus M, Thomas-Antérion C, Magne C, Vercelletto M, Bernard AM, Golfier V, Pasquier J, Michel BF, Namer I, Sellal F, Bochet J, Volteau M, Brice A, Meininger V; French Research Network on FTD/FTD-MND, Habert MO. Brain spect perfusion of frontotemporal dementia associated with motor neuron disease. Neurology. 2007 Jul 31;69(5):488-90.

ReferenceCitation: Le Ber I, Camuzat A, Hannequin D, Pasquier F, Guedj E, Rovelet-Lecrux A, Hahn-Barma V, van der Zee J, Clot F, Bakchine S, Puel M, Ghanim M, Lacomblez L, Mikol J, Deramecourt V, Lejeune P, de la Sayette V, Belliard S, Vercelletto M, Meyrignac C, Van Broeckhoven C, Lambert JC, Verpillat P, Campion D, Habert MO, Dubois B, Brice A; French research network on FTD/FTD-MND. Phenotype variability in progranulin mutation carriers: a clinical, neuropsychological, imaging and genetic study. Brain. 2008 Mar;131(Pt 3):732-46. doi: 10.1093/brain/awn012. Epub 2008 Feb 1.

family: Le Ber

full_name: Isabelle Le Ber

given: Isabelle

family: Camuzat

full_name: Agnès Camuzat

given: Agnès

family: Hannequin

full_name: Didier Hannequin

given: Didier

family: Pasquier

full_name: Florence Pasquier

given: Florence

family: Guedj

full_name: Eric Guedj

given: Eric

family: Rovelet-Lecrux

full_name: Anne Rovelet-Lecrux

given: Anne

family: Hahn-Barma

full_name: Valérie Hahn-Barma

family: van der Zee

full_name: Julie van der Zee

given: Julie

family: Clot

full_name: Fabienne Clot

given: Fabienne

family: Bakchine

full_name: Serge Bakchine

given: Serge

family: Puel

full_name: Michèle Puel

given: Michèle

family: Ghanim

full_name: Mustapha Ghanim

given: Mustapha

family: Lacomblez

full_name: Lucette Lacomblez

given: Lucette

family: Mikol

full_name: Jacqueline Mikol

given: Jacqueline

family: Deramecourt

full_name: Vincent Deramecourt

given: Vincent

family: Lejeune

full_name: Pascal Lejeune

given: Pascal

family: de la Sayette

full_name: Vincent de la Sayette

family: Belliard

full_name: Serge Belliard

family: Vercelletto

full_name: Martine Vercelletto

given: Martine

family: Meyrignac

full_name: Christian Meyrignac

given: Christian

family: Van Broeckhoven

full_name: Christine Van Broeckhoven

given: Christine

family: Lambert

full_name: Jean-Charles Lambert

given: Jean-Charles

family: Verpillat

full_name: Patrice Verpillat

location_facility: Hôpital Pitié-Salpêtrière - Fédération de Neurologie

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Hôpital Pitié-Salpêtrière - Centre du Langage-Neuropsychologie


title: Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock.

acronym: CATS

summary: Catecholamines infusion is a major component of septic shock management. International guidelines recommend that norepinephrine should be preferred to epinephrine, though phase III trials are lacking. The present study aimed at comparing the efficacy and safety of norepinephrine plus dobutamine to that of epinephrine in adults with septic shock.

ReferenceCitation: Annane D, Vignon P, Renault A, Bollaert PE, Charpentier C, Martin C, Troché G, Ricard JD, Nitenberg G, Papazian L, Azoulay E, Bellissant E; CATS Study Group. Norepinephrine plus dobutamine versus epinephrine alone for management of septic shock: a randomised trial. Lancet. 2007 Aug 25;370(9588):676-84. Erratum in: Lancet. 2007 Sep 22;370(9592):1034.

lead_sponsor: University of Versailles

location_facility: Réanimation Polyvalente - Hôpital Saint Joseph

location_facility: Réanimation Médicale - Hôpital André Mignot

location_facility: Réanimation Polyvalente - Institut Gustave Roussy

location_facility: Réanimation Médicale - Hôpital Saint Louis

location_facility: Réanimation Médicale - Hôpital Georges Pompidou

location_facility: Réanimation Polyvalente - Hôpital Dupuytren

location_facility: Service de Réanimation Médicale - Hôpital Central

location_facility: Réanimation Chirurgicale - Hôpital Central

location_facility: Service de Réanimation Médicale - Hôpital Poincaré

location_facility: Réanimation Polyvalente - Hôpital de Corbeil

location_facility: Service d'anesthésiologie - HIA Val de Grâce

location_facility: Réanimation Médicale - Hôpital Louis Mourier


title: Determination of Carboplatin's Optimal Plasmatic Exposure

summary: To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.

location_facility:
CHU de Nîmes
Centre Antoine Lacassagne
CHRU Bretonneau
Centre Paul Papin
Centre Val d'Aurelle
CHU de Toulouse Rangueil
Clinique Mathilde
CHU de la Timone
Hopital Européen Georges Pompidou
Institut Claudius Regaud
Clinique Pasteur
CHU A. Michallon
Centre René Gauducheau
Centre Oscar Lambert
Institut Bergonié


title: Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal cancer.

location_facility: Centre Hospital Universitaire Hop Huriez


title: Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.


title: Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to make cancer cells stop dividing so they stop growing or die. Combining chemotherapy with corticosteroids may be an effective treatment for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without doxorubicin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

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

location_facility: Centre Hospitalier General de Saint Nazaire


title: Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases

summary: Numerous studies have shown the diagnostic interest of cerebrospinal fluid kappa free light chains and kappa index in multiple sclerosis. However, large cohort studies are lacking and little is known about the correlation between kappa and lambda indexes and multiple sclerosis evidence disease activity. Therefore, this study plan to validate the kappa and lambda free light chains and indexes as diagnostic biomarker in multiple sclerosis and to correlate the concentration of kappa and lambda free light chains with clinical and radiological activity in a large cohort of patients.

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Assistance Publique des Hôpitaux de Paris

location_facility: Centre Hospitalier Régional et Universaitaire de Tours

location_facility: Assistance Publique des Hôpitaux de Marseille

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Grenoble


title: A Randomized, Open Label Study Comparing the Effect of CellCept With Therapeutic Drug Monitoring, Tacrolimus and a Corticosteroid-sparing Regimen Versus Fixed Dose CellCept, Tacrolimus and Corticosteroids Maintained up to 6 Months, on Acute Rejection and Safety in Liver Transplant Patients.

summary: This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


title: Real Life Prospective Multicentric Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG

acronym: REAL-MOOV-LUNG

summary: Evaluation of patient's proportion, whose management care has been modified at least once and specially by Moovcare® Lung application at 12 and 24 months.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Institut Curie

location_facility: Polyclinique de Limoges - Site de François CHENIEUX


title: Multicenter Pilot Clinical Study of Adjuvant Chemotherapy for Subjects Over 70 Years: Impact on the Independence and Quality of Life of the Administration of Anthracycline-Based Chemotherapy in Adjuvant Setting for Patients Presenting With Immediately Operable Breast Cancer, Hormone Receptor Negative (RH-), and Lymph Node Positive (pN+) or pN0 But of Scarff-Bloom-Richardson* Grade III and ≥ 2cm [GERICO]

summary:
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery.

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


title: Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous Labour. A Double-blind, Randomised, Controlled Trial

acronym: PROXYMA

summary:
The rate of caesarean section is higher among obese pregnant women, leading to increased morbidity in this already vulnerable population. Oxytocin is the main drug used in obstetrics to optimize progress of labour, but observational studies have suggested that its efficiency may be insufficient in obese women with usual doses.

The research is a randomised controlled trial to test the effect of an increased oxytocin dose on the rate of caesarean section in obese primiparous women with spontaneous labour between two oxytocin dosage regimens.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CHU de Strasbourg (Hôpital de Hautepierre)


title: A Randomized, Placebo-controlled, Double-blinded, Phase II Study of Efficacy of Regorafenib as Maintenance Treatment in Patients With High Grade Bone Sarcomas at Diagnosis or Relapse and Without Complete Remission After Standard Treatment

acronym: REGOMAIN

summary:
This is a randomized, double-blinded, 2 arms study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or first relapse.

In the first arm, patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion, whereas in the second arm, patients will be treated with placebo + BSC (standard of care).

The comparison between this two arms will allow to determine whether or not regorafenib and BSC is efficient for disease control, in terms of Progression-Free Survival improvement.

status: Recruiting

location_facility: Institut de Cancerologie Lucien Neuwirth


title: 9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial

summary: The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.

ReferenceCitation: Barrellier MT, Lebel B, Parienti JJ, Mismetti P, Dutheil JJ, Vielpeau C; PROTHEGE study group; GETHCAM study group. Short versus extended thromboprophylaxis after total knee arthroplasty: a randomized comparison. Thromb Res. 2010 Oct;126(4):e298-304. doi: 10.1016/j.thromres.2010.07.018. Epub 2010 Aug 24.

family: Barrellier

full_name: Marie-Thérèse Barrellier

given: Marie-Thérèse

family: Lebel

full_name: Benoît Lebel

given: Benoît

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Mismetti

full_name: Patrick Mismetti

given: Patrick

family: Dutheil

full_name: Jean-Jacques Dutheil

family: Vielpeau

full_name: Claude Vielpeau

given: Claude

journal_name: Thrombosis Research

title: Short versus extended thromboprophylaxis after total knee arthroplasty: A randomized comparison

lead_sponsor: University Hospital, Caen

location_facility:
Hospital University Angers
Hospital Alençon
Polyclinique de Riaumont
Reims University Hospital
Caen University hospital
Clinique St Marie
Clinique du Cèdre
Mignot Hospital
Hospital Nord Mayenne
Clinique St André
Hospital Val D'ariège
Clinique St Jean Languedoc
Clinique St Jean
Poitiers University Hospital
Montluçon Hospital
Hospital La Roche sur Yon
Hospital University Lille


title: Follow-up of Respiratory Sequelae of Patients Hospitalized With SARS-CoV-2: a Prospective Multicenter Observational Study

acronym: SISCOVID

summary: The objective of this multicenter observational study is to describe respiratory sequelae of COVID-19 patients hospitalized for severe pneumonia requiring oxygen supply.

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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

location_facility: Centre Hospitalier Le Raincy Montfermeil

location_facility: Centre Hospitalier Régional Metz-Thioville

location_facility: Centre Hospitalier de la Côte Basque - Bayonne

location_facility: Centre Hospitalier Robert Boulin - Libourne

location_facility: Centre Hospitalier Départemental Vendée - La Roche sur Yon


title: French Prospective Multicentre Non-Interventional Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice

acronym: DELTA

summary: The aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world conditions.

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Centre hospitalier de Lille-Hopital de Flandre

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Institut de Médecine de la Reproduction (there may be other sites in this country)


title: Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy: a Prospective Randomized Comparative Phase II Trial

summary:
This is a phase II, multicenter, randomized open-label and comparative study designed to evaluate whether local consolidative radiotherapy plus standard of care improves overall survival as compared to standard of care in patients with limited metastatic urothelial bladder cancer and without progression following the initial phase of first-line systemic therapy.

Each patient will be followed during 4 years from the date of randomization.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


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

lead_sponsor: UNICANCER

acronym: PEVOsq

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

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

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

title: Phase II Basket Trial Evaluating the Efficacy of a Combination of Pembrolizumab and Vorinostat in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma

summary: Interventional study evaluating the efficacy of an immunotherapy (pembrolizumab) in combination with a targeted therapy (vorinostat) in patient with recurrent and/or metastatic squamous cell carcinoma (localisations : head and neck, lung, cervix, anus, vulva, and penis)


title: Phase II Study to Evaluate the Efficacy of 12-month Neoadjuvant Chemotherapy in Terms of Disease-free Survival in Patients With Localized Digestive Neuroendocrine Carcinomas

acronym: NEONEC

summary:
NEONEC is a single-phase, phase II study evaluating the efficacy of the 12-month neoadjuvant chemotherapy in patients with locally differentiated digestive NEC. The recommended chemotherapy is based on the current reference combination of platinum (cisplatin or carboplatin) and etoposide (VP16). For anorectal locations, radiochemotherapy is proposed to avoid the morbidity of conventional surgery.

The objective of the study is to improve relapse-free survival (RFS) in NEC patients treated with neoadjuvant chemotherapy followed by surgery or chemoradiotherapy.

In parallel, we will perform a prospective cohort study with patients whose diagnosis is made during surgery, who have not received neoadjuvant treatment, and who are offered an adjuvant treatment of the same type (combination of platinum and platinum salts and etoposide).

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon


title: Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure

acronym: APPLIMONCOEUR

summary: Heart failure is a chronic disease that requires careful monitoring and therapeutic education. Smartphones have made their appearance in patients lives and allow close contact with them. The possibility of using a digital application dedicated to patients with heart failure concerning the symptoms to be monitored, treatments, diet, appointments, physical activity could improve the monitoring and the prognosis of patients following their hospitalization.

primary_purpose: Supportive Care

lead_sponsor: French Cardiology Society

location_facility:
CHU Amiens - Picardie - Site Sud
Hospices Civils de Lyon
CHU Henri Mondor
Hôpital Européen Georges Pompidou
CHU de ROUEN - Hôpital Charles Nicolle
CHRU de Lille
CHU de Poitiers
Hôpital Sainte Musse de Toulon
CHU de Grenoble
CHRU de Strasbourg
Hôpital Universitaire Pitié Salpêtrière
Hôpital Bicêtre
CHU de Toulouse
Hôpital Lariboisière


title: Adjunctive DobutAmine in sePtic Cardiomyopathy With Tissue Hypoperfusion: a Randomized Controlled Multi-center Trial

acronym: ADAPT

summary:
Sepsis induces both a systolic and diastolic cardiac dysfunction. The prevalence of this septic cardiomyopathy ranges between 30 and 60% according to the timing of assessment and definition used. Although the prognostic role of septic cardiomyopathy remains debated, sepsis-induced left ventricular (LV) systolic dysfunction may be severe and associated with tissue hypoperfusion, while it appears to fully recover in survivors. Accordingly, optimization of therapeutic management of septic cardiomyopathy may contribute to improve tissue hypoperfusion in increasing oxygen delivery, and to reduce related organ dysfunctions in septic shock patients.

Echocardiography is currently the recommended first-line modality to assess patients with acute circulatory failure.

Current Surviving Sepsis Campaign strongly recommends Norepinephrine as the first-choice vasopressor in fluid-filled patients with septic shock. In contrast, the use of Dobutamine is only suggested (weak recommendation, low quality of evidence) in patients with persistent tissue hypoperfusion despite adequate fluid resuscitation and vasopressor support. Levosimendan, an alternative inodilator, has failed preventing acute organ dysfunction in septic patients and has induced more supraventricular tachyarrhythmias than in the control group. Data supporting Dobutamine in this setting are scarce and primarily physiologic and based on monitored effects of this drug on hemodynamics and indices of tissue perfusion.

No randomized controlled trials have yet compared the effects of Dobutamine versus placebo on clinical outcomes. In open-labelled, small sample trials, the ability of septic patients to increase their oxygen delivery during Dobutamine administration appears to be associated with lower mortality.

The tested hypothesis in the ADAPT trial is that Dobutamine will reduce tissue hypoperfusion and associated organ dysfunctions in patients with septic shock and associated septic cardiomyopathy. In doing so, it may participate in improving clinical outcomes.

lead_sponsor: University Hospital, Limoges

location_facility:
CHU Orléans - service de Réanimation
Hôpital Cochin - service de Réanimation
CHU Tours - Service de Réanimation
Angouleme Hospital
Aphp - Henri Mondor
Argenteuil Hospital
CHU de Nancy
Dijon university hospital
University Hospital
Limoges University Hospital
Poitiers University Hospital
CHU Strasbourg - service de Réanimation
Aphp - Ambroise Paré


title: Phase III Trial to Assess Impact of Ultra-long Versus Long Down-regulation Protocol on IVF/ICSI Outcomes in Infertile Women Presenting With Adenomyosis.

acronym: ADENOFIV

summary:
Adenomyosis is a benign condition defined as the invasion of ectopic endometrium into the myometrium, resulting in smooth muscle hyperplasia and endometrial inflammation, commonly associated with endometriosis and uterine fibroids.

Heterogeneity among studies regarding diagnostic criteria and therapeutic management has fed the debate surrounding the impact of adenomyosis on assisted reproductive therapy outcomes. Nevertheless, recent data support that adenomyosis impairs reproductive outcomes associated with in vitro fertilization (IVF). According to several experimental data, prolonged exposure to gonadotropin releasing hormone (GnRH) agonists may overcome part of the detrimental impact of adenomyosis on fertility outcome. Overall, GnRH agonist treatment resulted in decreased local production of cytochrome P450 aromatase, decreased intrauterine concentration of free radicals and reduced inflammatory response and angiogenesis in endometrium, myometrium and adenomyosis lesions. At the same time, GnRH agonists affect neither endometrial capacity to support invasion nor invasive potential of the blastocyst in the early stages of implantation.

For IVF, 2 main protocols based on GnRH agonist pituitary down-regulation are available:

the long protocol involving a 15 days pituitary down-regulation;
the ultra-long protocol involving a 3 months pituitary down-regulation. Most studies using ultra-long protocol reported similar IVF outcomes in adenomyosis patients and control groups. Conversely, studies involving long or GnRH antagonist protocols demonstrated a significant reduction in clinical and ongoing pregnancy rates in adenomyosis patients compared to control subjects. Thus supporting that ultra-long protocol may be beneficial to improve IVF outcomes in the setting of adenomyosis.This is what investigators would like to demonstrate in this study

lead_sponsor: University Hospital, Toulouse

location_facility: Centre hospitalier intercommunal de Créteil


title: Efficacy of Non-instrumental Pleural Chest Physiotherapy (KRP-NI) in Initial Management of Infectious Pleural Effusion

acronym: KINEPANCH

summary: The main purpose of this study is to assess efficacy of non instrumental pleural chest physiotherapy on the recovery of respiratory function, at hospital discharge or 15 days after beginning the pleural chest physiotherapy, compared to physiotherapy with standard mobilization, in patients with infectious pleural effusion, who have received usual medical treatment.

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Centre Hospitalier Intercommunal - Créteil

location_facility: Centre Hospitalier Henri Duffaut - Avignon

location_facility: Centre Hospitalier Universitaire de Grenoble


acronym: BladderSpar

location_facility: INSTITUT de CANCEROLOGIE DE L'OUEST - site René Gauducheau

title: Phase II Study of Maintenance Anti-PD-L1 Treatment With Atezolizumab After Chemo-radiotherapy for Muscle-infiltrating Bladder Cancer Patients Not Eligible for Radical Cystectomy: Bladder Sparing

summary:
Patients older than ≥18 years, with muscle-invasive bladder cancer unfit for radical cystectomy because of age, comorbidities, and/or patient's refusal.

This study is designed as a multicentre, single-arm phase II study.


title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.

ReferenceCitation: Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11.

family: Barthel

full_name: H Richard Barthel

given: H Richard

family: Peniston

full_name: John H Peniston

given: John H

family: Clark

full_name: Michael B Clark

given: Michael B

family: Gold

full_name: Morris S Gold

given: Morris S

family: Altman

full_name: Roy D Altman

given: Roy D

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Novartis

location_country: Germany France


title: Prevalence and Vulnerability Factors of Active Cybersexuality Among Teenagers (15 - 17 Olds) in West Normandy.

summary: This study evaluates prevalence of active cybersexuality among teenagers (15-17 old) in West Normandy and find different factors of vulnerability that could induce this behaviour. Selection of teenagers in different schools (general, professional, agricultural, reintegration structure).

time_perspective: Other

ReferenceCitation: Braun-Courville DK, Rojas M. Exposure to sexually explicit Web sites and adolescent sexual attitudes and behaviors. J Adolesc Health. 2009 Aug;45(2):156-62. doi: 10.1016/j.jadohealth.2008.12.004. Epub 2009 Feb 20.

ReferenceCitation: Strassberg DS, McKinnon RK, Sustaíta MA, Rullo J. Sexting by high school students: an exploratory and descriptive study. Arch Sex Behav. 2013 Jan;42(1):15-21. doi: 10.1007/s10508-012-9969-8. Epub 2012 Jun 7.

ReferenceCitation: Temple JR, Paul JA, van den Berg P, Le VD, McElhany A, Temple BW. Teen sexting and its association with sexual behaviors. Arch Pediatr Adolesc Med. 2012 Sep;166(9):828-33. doi: 10.1001/archpediatrics.2012.835.

ReferenceCitation: Strassberg DS, Cann D, Velarde V. Sexting by High School Students. Arch Sex Behav. 2017 Aug;46(6):1667-1672. doi: 10.1007/s10508-016-0926-9. Epub 2017 Jan 3.

ReferenceCitation: Rice E, Gibbs J, Winetrobe H, Rhoades H, Plant A, Montoya J, Kordic T. Sexting and sexual behavior among middle school students. Pediatrics. 2014 Jul;134(1):e21-8. doi: 10.1542/peds.2013-2991.

location_facility:
ICEP CFA
MFR TRUN
Lycée Millet
La roquelle
CIFAC
Lycée jules verne
MFR
EPEI
Lycée marie curie
IME
Lycée Laplace
Cfai Uimm
Lycée de navarre
Lycée Allende


title: Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.

ReferenceCitation: Bécouarn Y, Senesse P, Thézenas S, Boucher E, Adenis A, Cany L, Jacob JH, Cvitkovic F, Montoto-Grillot C, Ychou M; Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer. A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer. Ann Oncol. 2007 Dec;18(12):2000-5. Epub 2007 Sep 4.

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

location_facility: Centre Hospitalier de L' Agglomeration Montargoise

location_facility: Centre Hospitalier General Lucien Hussel

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Pole Sante Sarthe et Loir Hopital Pierre Daguet


title: Alternation of FOLFOX6 (Oxaliplatin - Leucovorin - Fluorouracil) and FOLFIRI (Irinotecan - Leucovorin - Fluorouracil) as Second Line Treatment of Metastatic Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy.

location_facility: Centre Hospital Universitaire Hop Huriez


title: Phase 2, Multicenter, Prospective Cohort Study, Estimating the Efficacy of Focused HIFU Therapy in Patients With Localized Intermediate Risk Prostate Cancer

acronym: FOCALE

summary: The aim of the focal treatment HIFU is to destroy the cancer without causing side effects in contrast to radical treatments. Radical treatments (surgery or radiation therapy) are the standard therapies for patient with intermediate risk localized prostate cancer and good life expectancy (prostatectomy if life expectancy10 years) By destroying only the part of the gland that harbors cancer, it may indeed be possible to provide efficient cure of the disease while minimizing treatment-induced morbidity (incontinence and loss of potency). Around 20% of patients presented with a unilateral tumor: this patients are currently treated radically. No study published papers reported outcomes of a large population (>100) with intermediate risk cancers treated with Focal-HIFU (conducted with the Focal One® device). Focal therapy must be only offer within clinical trial setting (EAU (European Association of Urology) Guidelines ). The aim of this cohort will be to determine the success rate of Focal-HIFU in this intermediate risk population. The result the study will be used for calculation the arms of a future random study

lead_sponsor: Hospices Civils de Lyon

location_country: Sweden France

location_facility: Hôpital L. Pasteur, Hôpitaux Civils de Colmar

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

location_facility: Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,

location_facility: Département d'Urologie, Institut Montsouris

location_facility: Service d'Urologie, Clinique Tivoli Ducos

location_facility: Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord

location_facility: Service d'Urologie CHRU de Lille, Hôpital HURIEZ

location_facility: Service d'Urologie Générale de Santé - Hôpital Privé La Louvière

location_facility: Clinique Générale Beaulieu - Swiss International Prostate Center


title: Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use

acronym: PERSON-AL

summary:
The present project propose to study the effectiveness of a personalized care management of psycho-behavioral symptoms based on an evidence-based standardized assessment to identify and understand the underlying causes of psycho-behavioral symptoms followed by a personalized intervention based on targeted and prioritized actions. This personalized intervention is proposed both to Alzheimer disease (AD) patients living at home with agitation-type psycho-behavioral symptoms, and also to their caregivers with the support and coordination of a nurse working in collaboration with the specialist physician and the General Practitioner (GP). News technologies are used to enhance the follow-up, based on telehealth, and caregiver training.

The project hypothesize that, for a vulnerable population at risk (AD patient with agitation and their caregivers) living at home, a personalized intervention, carried out and coordinated by a nurse in close collaboration with the specialist and GP, would reduce hospitalizations and have a positive effect on the disease evolution and caregiver distress. Also this personalized intervention could reduce the cost of care, in particular by reducing the costs associated with hospitalizations and informal help.

location_facility: University Hospital Toulouse - Neurology department

location_facility: Toulouse University Hospital (CHU de Toulouse)

intervention_type: Behavioral