title: Nonfunctioning Small (≤2 cm) Neuroendocrine Pancreatic Incidentaloma: Clinical and Morphological Findings, and Therapeutic Options (IPANEMA)

summary: Neuroendocrine tumors (NETs) and carcinomas account for 10-15 % of all pancreatic incidentalomas. The management of pancreatic NETs depends on tumor stage and on presence or not of hormonal syndrome. The therapeutic approach for hormonally functional tumor, or large tumor (> 2 cm) with local, vascular or lymph nodes invasion, highly suggestive of malignancy, or in presence of metastasis, is well admitted: surgery is indicated or should be discussed. However, the attitude is less consensual for small (≤ 2 cm) non-functioning (NF) and non-metastatic lesions. In English, American or French recommendations, systematic surgical resection with lymphadenectomy is currently recommended in all medically fit patients. The follow-up (FU) is possible for tumors <2 cm (T1) located in the pancreatic head and for which enucleation is not feasible. Several recently published retrospective studies discuss the "non- surgical" management of the small NF incidentally detected pancreatic NETs (IPNETs) and highlight the necessity of developing guidelines for management of these patients. A strict correlation between tumor size and malignancy of these tumors was demonstrated in the single-center retrospective Italian study of Bettini and col., which included all patients with NF PNETs who underwent curative (R0) resection during 18 years. In the group of 51 patients with small size of T (2 cm or less), incidentally discovered, the majority of lesion was benign, and the authors concluded that follow-up can be proposed in patients with incidentally discovered NF PNETs ≤ 2 cm. However in despite of small size and asymptomatic character of the tumor, the rate of malignancy of NF IPNETs ≤ 2 cm was estimated to be 24 % (in 18% and 6% of cases, uncertain behaviour and carcinoma were present). Given the inherent morbidities associated with pancreatic surgery, a risk-benefit calculation may favour surveillance rather than surgery in highly selected patients. Thus, a better understanding of NF IPNETs and identification of their prognostic factors can be of help to select a subgroup of patients who could benefit from a long-term surveillance rather than a systematic surgical resection. Clearly, large prospective trials are needed to validate this approach.

lead_sponsor: Société Française d'Endoscopie Digestive

location_country: Belgium France

location_facility:
Hopital Saint Joseph
Hopital Beaujon
CHRU Jean Minjoz
Hopital Bocage central
Hopital Edouard Herriot
CHU Rangueil
Hopital Privé Européen
Clinique du Trocadero
Hopital du Haut Leveque
Hopital Privé Jean Mermoz
Hopital de la Timone
Hopital Sud
Hopital Cochin
Clinique Universitaire Saint Luc
CHU Angers
Hotel Dieu
Institut Paoli Calmette
Hopital Nord
Hopital de l'archet 2
Hopital Robert Debré
Centre Hospitalier Lyon Sud
Hopital Européen George Pompidou


study_start_date_type: Actual

acronym: DoubleITK

intervention_type: Drug

lead_sponsor: University Hospital, Lille

summary: Open label non-randomized multicenter phase 2 trial with direct individual benefice

sponsor_collaborators:
University Hospital, Lille
Novartis

location_facility: Diseases of Blood Service HURIEZ hospital CHRU de LILLE

status: Completed

title: Efficacy and Safety of Nilotinib in Patients With a Chronic Disease of the Graft Against the Host (Graft Versus Host, GVH) Did Not Respond to Imatinib Mesylate.

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

study_completion_date_type: Actual

study_type: Interventional

lead_sponsor_type: academique

status_simplified: Completed


title: Validation of the SEPSIS-3 Criterion for Sepsis and Septic Shock in the Emergency Department

acronym: SCREEN

summary:
Investigators aim to evaluate the SEPSIS 3 criterion for "sepsis" and "septic shock" in a prospective manner.

Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population of emergency patients with infection

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Freund Y, Lemachatti N, Krastinova E, Van Laer M, Claessens YE, Avondo A, Occelli C, Feral-Pierssens AL, Truchot J, Ortega M, Carneiro B, Pernet J, Claret PG, Dami F, Bloom B, Riou B, Beaune S; French Society of Emergency Medicine Collaborators Group. Prognostic Accuracy of Sepsis-3 Criteria for In-Hospital Mortality Among Patients With Suspected Infection Presenting to the Emergency Department. JAMA. 2017 Jan 17;317(3):301-308. doi: 10.1001/jama.2016.20329.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Université de Lausanne - SERVAL

version: publishedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repository_normalized: HAL

version: submittedVersion

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

unpaywall_oa_status: green

publisher_dissemination: American Medical Association

ipd_sharing: Undecided

lead_sponsor: Societe Française de Medecine d'urgence

location_country: Spain Switzerland Belgium France

location_facility:
HEGP
Cochin
St Louis
Tenon
CHUV
CHIPO
Longjumeau
Ambroise Paré
Vienne
Clinic hospital Barcelona
Lyon
Saint Camille
Avicenne
CHU Angers
Princess Grace
Bichat
Saint-Antoine
Toulouse
Nancy
Pitie-salpetriere
Lariboisière
Grenoble
Nice
Dijon
St Luc
Tours
Strasbourg

lead_sponsor_type: industriel


title: A EUROPEAN, MULTICENTRE, PHASE II/III RANDOMISED DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING LANREOTIDE AS MAINTENANCE THERAPY IN PATIENTS WITH NON-RESECTABLE DUODENO-PANCREATIC NEUROENDOCRINE TUMOURS AFTER FIRST-LINE TREATMENT

acronym: REMINET

summary: This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.

status: Terminated

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Lepage C, Dahan L, Bouarioua N, Toumpanakis C, Legoux JL, Le Malicot K, Guimbaud R, Smith D, Tougeron D, Lievre A, Cadiot G, Di Fiore F, Bouhier-Leporrier K, Hentic O, Faroux R, Pavel M, Borbath I, Valle JW, Rinke A, Scoazec JY, Ducreux M, Walter T. Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours. Dig Liver Dis. 2017 May;49(5):568-571. doi: 10.1016/j.dld.2017.02.004. Epub 2017 Mar 11.

ReferenceType: result

ReferenceCitation: Guiney DG Jr, Hasegawa P, Davis CE. Homology between clindamycin resistance plasmids in Bacteroides. Plasmid. 1984 May;11(3):268-71. doi: 10.1016/0147-619x(84)90035-0.

ReferenceCitation: Lepage C, Phelip JM, Lievre A, Le-Malicot K, Dahan L, Tougeron D, Toumpanakis C, Di-Fiore F, Lombard-Bohas C, Borbath I, Coriat R, Lecomte T, Guimbaud R, Petorin C, Legoux JL, Michel P, Scoazec JY, Smith D, Walter T. Lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours: An international double-blind, placebo-controlled randomised phase II trial - Prodige 31 REMINET: An FFCD study. Eur J Cancer. 2022 Nov;175:31-40. doi: 10.1016/j.ejca.2022.07.033. Epub 2022 Sep 7.

license: cc-by-nc

license_normalized: cc-by-nc

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

repositories_concat: HAL

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

publisher_dissemination: Elsevier

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country:
Germany
United Kingdom
Belgium
France

location_facility: Royal Free Hospital Neuroendocrine Tumour Unit

location_facility: Hôpital Haut Lévêque Bat Magellan, Service d'hépato-gastroentérologie

location_facility: Manchester Academic Health Sciences Centre (MAHSC)

status_simplified: Unknown


title: Factors Determining Quality of Life Related to Respiratory Status According to Gender of COPD Patients Followed by a Pneumologist

acronym: VITALITE

summary: The purpose of this study is to evaluate with sufficient precision and according to gender the determining independent factors of quality of life related to respiratory status of patient with moderate to severe COPD.

time_perspective: Cross-Sectional

lead_sponsor: AstraZeneca


title: Impact of the Use of a Computerized Protocol for Glucose Control Named CGAOtm on the Outcome of Critically Ill Patients

acronym: CGAO-REA

summary: The aim of the study is to determine whether the use of the CGAOtm software is associated with a decrease in 90-day mortality when compared with the use of standard care methods for glucose control with target blood glucose levels inferior to 180 mg/dl. The CGAOtm software is designed to assist physicians and nurses in achieving tight glucose control (defined by a target for blood glucose levels between 80 and 110 mg/dl) in critically ill patients.

ReferenceCitation: Carli P, Martin C. [Impact of Nice-Sugar: is there a need for another study on intensive glucose control in ICU?]. Ann Fr Anesth Reanim. 2009 Jun;28(6):519-21. doi: 10.1016/j.annfar.2009.05.002. Epub 2009 Jun 4. No abstract available. French.

ReferenceCitation: Guerrini A; Roudillon G; Gontier O; Rebaï L; Isorni MA; Mutinelli-Szymanski P; Sorine M; Kalfon P. High glycemic variability induced by inappropriate algorithms for intensive insulinotherapy: the example of the NICE-SUGAR study. Abstract award winners: The best pre-selected abstracts of the 22th Annual Congress of the European Society of Intensive Care Medicine, 11-14 October 2009, Vienna, Austria. Intensive Care Med. 2009 Sep;35 Suppl 1:S111.

ReferenceCitation: Gontier O; Hamrouni M; Lherm T; Monchamps G; Ouchenir A; Kalfon P. The CGAO software improves glycaemic control in intensive care patients without increasing the incidence of severe hypoglycaemia nor the nurse workload. Abstracts of the 21th Annual Congress of the European Society of Intensive Care Medicine, 21-24 September 2007, Lisbon, Portugal. Intensive Care Med. 2008 Sep;34 Suppl 2:S220.

ReferenceCitation: Abstracts of the 20th Annual Congress of the European Society of Intensive Care Medicine, 7-10 October 2007, Berlin, Germany. Intensive Care Med. 2007 Sep;33 Suppl 2:S5-271. No abstract available.

ReferenceCitation: Kalfon P, Le Manach Y, Ichai C, Brechot N, Cinotti R, Dequin PF, Riu-Poulenc B, Montravers P, Annane D, Dupont H, Sorine M, Riou B; CGAO-REA Study Group. Severe and multiple hypoglycemic episodes are associated with increased risk of death in ICU patients. Crit Care. 2015 Apr 8;19(1):153. doi: 10.1186/s13054-015-0851-7.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - TEL - Thèses en ligne

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Kalfon P, Giraudeau B, Ichai C, Guerrini A, Brechot N, Cinotti R, Dequin PF, Riu-Poulenc B, Montravers P, Annane D, Dupont H, Sorine M, Riou B; CGAO-REA Study Group. Tight computerized versus conventional glucose control in the ICU: a randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):171-181. doi: 10.1007/s00134-013-3189-0. Epub 2014 Jan 14.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Springer

lead_sponsor: Centre Hospitalier of Chartres

collaborators: Société Française d'Anesthésie et de Réanimation

location_facility: CHU de Bordeaux - Groupe Hospitalier Sud, Hôpital Haut Lévêque

location_facility: Centre Hospitalier Départemental Les Oudairies

intervention_type: Device


title: Validation of a Predictive Risk Equation for Type 2 Diabetes in Children With Diabetes to Achieve a Predictive Diagnostic Biochip for the Early Detection of Individuals at Risk in Families.

acronym: DESCENDANCE

summary:
Considering its epidemic-like development worldwide, associated with modifications in lifestyle, as well as its enormous social and economic weight, the prevention of type II diabetes is certain to be a central concern of health systems within the developed countries in the decades to come. However, while simple obesity concerns the entire population, type 2 diabetes affects only one sub-population at high genetic risk. To be effective and realistic in economic terms, efforts at prevention must be thus targeted towards these subjects at high risk. The key issue involves identifying such subjects early enough so that a strategy of effective prevention can be organized in good time.

Until now, efforts have been concentrated on individuals at risk for diabetes readily identifiable within the general population, typically subjects in the second half of adulthood, presenting abdominal obesity and mild abnormalities of blood sugar. Preventive lifestyle and dietary measures are proposed but are constrictive and difficult to maintain over time, and the results, although they may be significant, remain disappointing, with mere postponement of an outcome which at this stage appears inevitable. The reason is ascribable to excessively tardy intervention, when the pathogenic process has already been ongoing for some ten years and the endocrine function of the pancreas is probably already irreparably impaired.

The alternative thus is earlier intervention, in childhood, adolescence or early adulthood. The problem is to identify individuals at high risk of becoming diabetic at a time when they are presenting no simple clinical or laboratory abnormalities allowing easy diagnosis. The familial character of type 2 diabetes is now well established, and future diabetic subjects are themselves above all the children of diabetic subjects. However, the prevalence of the disease among the descendants of type 2 diabetic subjects is around 20-30% and predictive tools are needed to combat diabetes in these high-risk families.

We propose to create a risk equation using an algorithm to reliably predict children most likely to develop diabetes later in life.

The algorithm will include 3 classes of data:

The genotype stemming from the genetic characterization of individuals and those their parents;
Environmental data concerning childhood, especially eating habits and physical activity;
Data of the mother who was eventually diabetic during pregnancy.

From a methodological standpoint, it would be rather difficult to take blood samples from children and wait some 50 years to determine whether or not they develop diabetes. To circumvent this difficulty, we will recruit subjects in families with a history of type II diabetes:

Parents alive, including at least one type 2 diabetic subject
Adult children (aged over 35 years), some of whom are already presenting type II diabetes, and healthy brothers and sisters, who form the control population. Test will be done to determine whether healthy subjects are really safe from the risk of diabetes (HbA1c measurement and glucose load test).

The Descendence study will include 500 families at risk involving about 3000 subjects (1000 subjects with diabetes and 2000 healthy subjects). It is expected to answer the following question: for a child born in such families at risk, what is the probability of developing diabetes later in life, so that early preventive action may be taken

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
CHU de Bondy
CHU de Nancy
CHU de Caen
CH Sud Francilien
CHU Marseille Hôpitaux Sud
CHU Toulouse
University Hospital Grenoble
Centre Hospitalier Strasbourg
CHU Sart Tilman Liège
CHU Avicenne
CHU de BREST
CHRU Lille
CHU de Bicetre
CHU Bichat
CHU de REIMS
CHU de Nantes
CHU Jean Minjoz

intervention_type: Other


title: Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care

acronym: ACCESS

summary: This is a prospective, observational, non-drug interventional, non-randomized study to compare the rate of moderate-severe COPD exacerbations in patients of all Chronic Obstructive Pulmonary Disease (COPD) severities with and without cardiovascular diseases. A total study population of 3330 subjects will be recruited by general practitioners (GPs) and assessed over a 27 month time frame.

lead_sponsor: GlaxoSmithKline

location_country: Germany Poland Netherlands Belgium Spain France

intervention_type: Procedure


title: A Phase III Randomized Study Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer

acronym: CHIPOR

summary: CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Brigand C, Monneuse O, Mohamed F, Sayag-Beaujard AC, Isaac S, Gilly FN, Glehen O. Peritoneal mesothelioma treated by cytoreductive surgery and intraperitoneal hyperthermic chemotherapy: results of a prospective study. Ann Surg Oncol. 2006 Mar;13(3):405-12. doi: 10.1245/ASO.2006.05.041. Epub 2006 Jan 30.

ReferenceCitation: Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.

lead_sponsor: UNICANCER

location_country: Spain Belgium France

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Centre Hospitalier Universitaire Saint Etienne- Hopital Nord

location_facility: Centre Hospitalier Universitaire Dupuytren

status_simplified: Ongoing


acronym: NEPHRUTIX

lead_sponsor: University Hospital, Limoges

summary:
Background

Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine).

Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with failure or toxic side effects of other immunosuppressant treatments is a major matter of concern.

Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this treatment for years. At the same time, low doses of cyclosporine allow proteinuria to reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis. Some recent data lead to the conclusion that Rituximab may be effective in such a disease, with a cyclosporin sparing effect.

Purpose

The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome.

Abstract Patients will be included in the study in a period of remission of proteinuria. Two infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one week of interval. Other immunosuppressant treatments will be gradually tapered off with the same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding code will be broken. Rituximab will then be infused to patients having received placebo.

sponsor_collaborators:
University Hospital, Limoges
Hoffmann-La Roche

location_facility: Queen Fabiola Universitary Children's Hospital

title: A Prospective, Randomized, Double Blind, Placebo-controlled Phase II/III Study Evaluating the Efficacy of Rituximab in the Prevention of Relapse of Calcineurin Inhibitors Dependent Idiopathic Nephrotic Syndrome of Childhood


title: Open-label Study of Bevacizumab Maintenance Therapy (AVASTIN®) With or Without Pemetrexed After First-line Chemotherapy With Bevacizumab-cisplatin-pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)

summary: This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is <500 individuals.

ReferenceCitation: Barlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikstrom A, Wong EK, Perez-Moreno P, Mitchell L, Groen HJ. Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non-small-cell lung cancer: AVAPERL (MO22089). J Clin Oncol. 2013 Aug 20;31(24):3004-11. doi: 10.1200/JCO.2012.42.3749. Epub 2013 Jul 8.

oa_host_type: closed

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Sweden
Netherlands
Switzerland
United Arab Emirates
Korea, Republic of
Spain
Greece
Turkey
Russian Federation
France


summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, 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. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.

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

location_facility: Centre Hospital Regional Universitaire de Limoges

title: Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer

type: Other Identifier


title: Multicenter Phase III Randomized Study of FOLFIRI Plus Bevacizumab Following or Not by a Maintenance Therapy With Bevacizumab in Patients With Non-Pretreated Metastatic Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given with or without bevacizumab in treating patients with metastatic colorectal cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with or without bevacizumab to see how well it works in treating patients with metastatic colorectal cancer.

ReferenceCitation: Aparicio T, Linot B, Le Malicot K, Bouche O, Boige V, Francois E, Ghiringhelli F, Legoux JL, Ben Abdelghani M, Phelip JM, Faroux R, Dahan L, Taieb J, Bedenne L. FOLFIRI+bevacizumab induction chemotherapy followed by bevacizumab or observation in metastatic colorectal cancer, a phase III trial (PRODIGE 9--FFCD 0802). Dig Liver Dis. 2015 Apr;47(4):271-2. doi: 10.1016/j.dld.2015.01.146. Epub 2015 Jan 20. No abstract available.

ReferenceCitation: Aparicio T, Ghiringhelli F, Boige V, Le Malicot K, Taieb J, Bouche O, Phelip JM, Francois E, Borel C, Faroux R, Dahan L, Jacquot S, Genet D, Khemissa F, Suc E, Desseigne F, Texereau P, Lepage C, Bennouna J; PRODIGE 9 Investigators. Bevacizumab Maintenance Versus No Maintenance During Chemotherapy-Free Intervals in Metastatic Colorectal Cancer: A Randomized Phase III Trial (PRODIGE 9). J Clin Oncol. 2018 Mar 1;36(7):674-681. doi: 10.1200/JCO.2017.75.2931. Epub 2018 Jan 18.

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

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

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

ReferenceCitation: Aparicio T, Bennouna J, Le Malicot K, Boige V, Taieb J, Bouche O, Phelip JM, Francois E, Borel C, Faroux R, Dahan L, Bachet JB, Egreteau J, Kaminsky MC, Gornet JM, Cojocarasu O, Gasmi M, Guerin-Meyer V, Lepage C, Ghiringhelli F; for PRODIGE investigators/collaborators. Predictive factors for early progression during induction chemotherapy and chemotherapy-free interval: analysis from PRODIGE 9 trial. Br J Cancer. 2020 Mar;122(7):957-962. doi: 10.1038/s41416-020-0735-8. Epub 2020 Feb 4.

oa_colors: green hybrid

evidence: open (via crossref license)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

ReferenceCitation: Guilloteau A, Abrahamowicz M, Boussari O, Jooste V, Aparicio T, Quantin C, Le Malicot K, Binquet C. Impact of time-varying cumulative bevacizumab exposures on survival: re-analysis of data from randomized clinical trial in patients with metastatic colo-rectal cancer. BMC Med Res Methodol. 2021 Jan 9;21(1):14. doi: 10.1186/s12874-020-01202-9.

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

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

ReferenceCitation: Dohan A, Gallix B, Guiu B, Le Malicot K, Reinhold C, Soyer P, Bennouna J, Ghiringhelli F, Barbier E, Boige V, Taieb J, Bouche O, Francois E, Phelip JM, Borel C, Faroux R, Seitz JF, Jacquot S, Ben Abdelghani M, Khemissa-Akouz F, Genet D, Jouve JL, Rinaldi Y, Desseigne F, Texereau P, Suc E, Lepage C, Aparicio T, Hoeffel C; PRODIGE 9 Investigators and PRODIGE 20 Investigators. Early evaluation using a radiomic signature of unresectable hepatic metastases to predict outcome in patients with colorectal cancer treated with FOLFIRI and bevacizumab. Gut. 2020 Mar;69(3):531-539. doi: 10.1136/gutjnl-2018-316407. Epub 2019 May 17.

publisher_dissemination: British Medical Journal

sponsor_collaborators: Federation Francophone de Cancerologie Digestive

location_facility: Centre Radiothérapie et Oncologie de Moyenne Garonne

location_facility: Clinique Valdegour, Centre ONCOGARD - Institut de Cancérologie du Gard


title: Randomized Phase III Trial Comparing Early Treatment With Fludarabine/Cyclophosphamide + Rituximab Versus Deferred Treatment in Untreated Binet Stage A Patients With CLL and High Risk of Progression

summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving rituximab together with fludarabine and cyclophosphamide is more effective than observation alone in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying rituximab, fludarabine, and cyclophosphamide to see how well they work compared to observation alone in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.

ReferenceCitation: Sachanas S, Pangalis GA, Fink AM, Bahlo J, Fischer K, Levidou G, Kyrtsonis MC, Bartzi V, Vassilakopoulos TP, Kalpadakis C, Koulieris E, Moschogiannis M, Yiakoumis X, Tsirkinidis P, Angelopoulou MK, Eichhorst B, Hallek M. Small Lymphocytic Lymphoma: Analysis of Two Cohorts Including Patients in Clinical Trials of the German Chronic Lymphocytic Leukemia Study Group (GCLLSG) or in "Real-Life" Outside of Clinical Trials. Anticancer Res. 2019 May;39(5):2591-2598. doi: 10.21873/anticanres.13382.

ReferenceCitation: Herling CD, Cymbalista F, Gross-Ophoff-Muller C, Bahlo J, Robrecht S, Langerbeins P, Fink AM, Al-Sawaf O, Busch R, Porcher R, Cazin B, Dreyfus B, Ibach S, Lepretre S, Fischer K, Kaiser F, Eichhorst B, Wentner CM, Hoechstetter MA, Dohner H, Leblond V, Kneba M, Letestu R, Bottcher S, Stilgenbauer S, Hallek M, Levy V. Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial. Leukemia. 2020 Aug;34(8):2038-2050. doi: 10.1038/s41375-020-0747-7. Epub 2020 Feb 18.

repository_institution: Technische Universität München - mediaTUM Gesamtbestand

ipd_sharing: No

lead_sponsor: German CLL Study Group

location_country: Germany Austria France

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

location_facility: Internistische Gemeinschaftspraxis - Berlin

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

location_facility: Hamatologie/Onkologie Praxisgemeinschaft - Muenchen

location_facility: Klinikum Schwaebisch Gmuend Stauferklinik

location_facility: Schwerpunktpraxis fuer Haematologie und Onkologie

location_facility: Internistische Gemeinschaftspraxis - Friedberg

location_facility: Internistische Gemeinschaftspraxis - Kassel

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

location_facility: Praxis Fuer Haematologie Internistische Onkologie

location_facility: Internistische Gemeinschaftspraxis - Oldenburg

location_facility: Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin

location_facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

location_facility: Universitaetsklinik fuer Innere Medizin I

location_facility: Internistische Gemeinschaftspraxis - Offenbach

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Krankenhaus Siloah - Medizinische Klinik II

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Internistische Gemeinschaftspraxis - Forchheim

location_facility: Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Haematologische Praxis - Moenchengladbach

location_facility: Internistische Onkologische Praxis - Kronach

location_facility: Burkhard and Reimann Gemeinschaftspraxis

location_facility: Praxis fuer Innere Medizin Haematologie und Internistische Onkologie

location_facility: Internistische Gemeinschaftspraxis - Halle

location_facility: Staedtisches Klinikum Magdeburg - Altstadt

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Onkologische Gemeinschaftspraxis - Trier

location_facility: St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH


acronym: CPC

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

summary:
Despite the fact that a substantial response rate may be obtained in small-cell lung cancers (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More aggressive regimens remain controversial and recent attempts at increasing dose-intensity have been restricted to patients with a more favourable presentation.

Bevacizumab is a humanized monoclonal antibody which binds to VEGF (Vascular Endothelial Growth Factor). In association with double-drug standard chemotherapies, it has been proven that bevacizumab can improve survival of previously untreated advanced non-small-cell lung cancers (NSCLC), compared to chemotherapy without bevacizumab). Such promising effects on NSCLC deserve to be tested on small-cell lung cancers.

In this trial (IFCT-0802), standard chemotherapy (PCDE or PE) will be compared to experimental treatment (PCDE or PE + bevacizumab 7.5 mg/kg) for previously untreated SCLC patients.

ReferenceCitation: Pujol JL, Breton JL, Gervais R, Tanguy ML, Quoix E, David P, Janicot H, Westeel V, Gameroff S, Geneve J, Maraninchi D. Phase III double-blind, placebo-controlled study of thalidomide in extensive-disease small-cell lung cancer after response to chemotherapy: an intergroup study FNCLCC cleo04 IFCT 00-01. J Clin Oncol. 2007 Sep 1;25(25):3945-51. doi: 10.1200/JCO.2007.11.8109.

ReferenceCitation: Pujol JL, Daures JP, Riviere A, Quoix E, Westeel V, Quantin X, Breton JL, Lemarie E, Poudenx M, Milleron B, Moro D, Debieuvre D, Le Chevalier T. Etoposide plus cisplatin with or without the combination of 4'-epidoxorubicin plus cyclophosphamide in treatment of extensive small-cell lung cancer: a French Federation of Cancer Institutes multicenter phase III randomized study. J Natl Cancer Inst. 2001 Feb 21;93(4):300-8. doi: 10.1093/jnci/93.4.300.

ReferenceCitation: Horn L, Dahlberg SE, Sandler AB, Dowlati A, Moore DF, Murren JR, Schiller JH. Phase II study of cisplatin plus etoposide and bevacizumab for previously untreated, extensive-stage small-cell lung cancer: Eastern Cooperative Oncology Group Study E3501. J Clin Oncol. 2009 Dec 10;27(35):6006-11. doi: 10.1200/JCO.2009.23.7545. Epub 2009 Oct 13.

ReferenceCitation: Pujol JL, Lavole A, Quoix E, Molinier O, Souquet PJ, Barlesi F, Le Caer H, Moro-Sibilot D, Fournel P, Oster JP, Chatellain P, Barre P, Jeannin G, Mourlanette P, Derollez M, Herman D, Renault A, Dayen C, Lamy PJ, Langlais A, Morin F, Zalcman G; French Cooperative Thoracic Intergroup (IFCT). Randomized phase II-III study of bevacizumab in combination with chemotherapy in previously untreated extensive small-cell lung cancer: results from the IFCT-0802 trialdagger. Ann Oncol. 2015 May;26(5):908-914. doi: 10.1093/annonc/mdv065. Epub 2015 Feb 16.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Negre E, Coffy A, Langlais A, Daures JP, Lavole A, Quoix E, Molinier O, Greillier L, Audigier-Valette C, Moro-Sibilot D, Westeel V, Morin F, Roch B, Pujol JL. Development and Validation of a Simplified Prognostic Score in SCLC. JTO Clin Res Rep. 2020 Feb 12;1(1):100016. doi: 10.1016/j.jtocrr.2020.100016. eCollection 2020 Mar.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

location_facility:
Centre F. Baclesse
Saint Omer - CHI
Créteil - CHI
Metz - CHR
Saint Nazaire - Centre Etienne Dolet
Saint Priest en Jarez - ICL
Nancy - CHU
Meaux - CH
Armentières - CH
Toulouse - Clinique Pasteur
Neuilly - Hôpital Américain de Paris
Verdun - CHG
Saint Brieuc - CHG
Marseille - CRLCC
Pau - CH
Saverne - CH
Orléans - CH
Dijon - CHU
APHP - Saint-Antoine - pneumologie
CHU Grenoble - pneumologie
Centre Hospitalier - Pneumologie
Mont de Marsan - CH
Thonon les bains
CHU - Pneumologie
Dijon - CAC
Reims - CRLCC
Institut Gustave Roussy
Hôpital Percy-Armées - Pneumologie
Colmar - CH
Clermont Ferrand - CHU
Toulon - HIA
Maubeuge - Polyclinique du Parc
Nevers - CH
CHU Toulouse - Pneumologie
APHM - Hôpital Sainte Marguerite
CH
Tours - CHU
Annemasse - CH
Senlis - CH
Vesoul - CHI
CH - Compiègne
Harfleur - Clinique du Petit Colmoulins
Montpellier - CHRU
Chalons-en-Champagne - CH
Reims - CHU
HCL - Lyon Sud (Pneumologie)
Draguignan - CH
CHU Besancon - Pneumologie
Saint Quentin - CH
Rouen - CHU
Mulhouse - CH
Cahors - CH
Chauny - CH
Chartres - CH
APHP - Hopital Tenon - Pneumologie
Angers - CHU
Jonzac - CH
Suresnes - Hopital Foch
Nice - CAC
Nouvel Hopital Civil - Pneumologie

title: Randomized Phase II-III Study of Bevacizumab 7,5 mg/kg in Combination With Chemotherapy Versus Chemotherapy in Extensive-Disease Small-Cell Lung Cancer After Response to Chemotherapy : PCDE (cisPlatin - Cyclophosphamide - epiDoxorubicin - Etoposide) or PE (cisPlatin - Etoposide)


title: TRIAGE: TRIage of Sepsis At emerGency dEpartment

acronym: TRIAGE

summary:
Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately treated cases can lead to severe sepsis or septic shock; being characterized by high mortality and morbidity.

Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment very difficult in particular on Emergency Department (ED) patients due to their infectious illness background and the frequent comorbidities. Also, the severity of the condition may not be apparent at initial contact with ED personnel: patients may arrive at ED with mild clinical manifestation and rapidly progress to critical illness, or rather at the opposite others have benign evolution despite a similar symptoms. In these conditions, the main challenge of ED clinicians is differentiating mild infections from life-threatening ones in the heavy workload of ED environment Objective of TRIAGE project is to identify and validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department.

Targeted population is adult patients freshly admitted at ED, whom blood samples will serve to validate candidate markers.

ipd_sharing: Yes

lead_sponsor: BioMérieux

sponsor_collaborators:
BioMérieux
Centre Investigation Clinique, Limoges

location_facility: Centre Hospitalier Universitaire Edouard Herriot

location_facility: Assistance publique - Hôpitaux de Paris Hopital de Cochin

location_facility: Centre d'Investigation Clinique (CIC)-CHU Limoges

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Centre hospitalier universitaire Grenoble Alpes

location_facility: Centre Hospitalier Regional Universitaire de Besançon

location_facility: Cliniques universitaires Saint-Luc - UCL

location_facility: Centre Hospitalier Départemental - Hôpital La Roche-sur-Yon


title: A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old.

summary: The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses.

ReferenceCitation: Muresan B, Mamolo C, Cappelleri JC, Mokgokong R, Palaka A, Soikkeli F, Heeg B. Comparing cure rates for gemtuzumab ozogamicin plus standard chemotherapy vs standard chemotherapy alone in acute myeloid leukemia patients. Future Oncol. 2021 Aug;17(22):2883-2892. doi: 10.2217/fon-2020-1287. Epub 2021 Apr 16.

evidence: open (via page says license)

publisher_dissemination: Future Science Ltd

ReferenceCitation: Renneville A, Abdelali RB, Chevret S, Nibourel O, Cheok M, Pautas C, Dulery R, Boyer T, Cayuela JM, Hayette S, Raffoux E, Farhat H, Boissel N, Terre C, Dombret H, Castaigne S, Preudhomme C. Clinical impact of gene mutations and lesions detected by SNP-array karyotyping in acute myeloid leukemia patients in the context of gemtuzumab ozogamicin treatment: results of the ALFA-0701 trial. Oncotarget. 2014 Feb 28;5(4):916-32. doi: 10.18632/oncotarget.1536.

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

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Impact Journals, LLC

lead_sponsor: Acute Leukemia French Association

sponsor_collaborators:
Acute Leukemia French Association
Versailles Hospital

location_facility:
Hopital Saint-Louis
CHU
IGR
CH
Hopital Pitie-Salpetriere
Hopital Avicenne
Hospital Central
Hopital Edouard Herriot
Hopital Percy
CNLCC


title: A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. Post Study 5-year Follow-up

summary: This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study

lead_sponsor: Steba Biotech S.A.

collaborators: International Drug Development Institute

location_country:
Finland
Italy
Germany
United Kingdom
Sweden
Netherlands
Spain
France

location_facility: Department of Urology-Tampere University Hospital-

location_facility: Department of Urology-Hospital Clinic, University of Barcelona

location_facility: Centre Hospitalier Universitaire Lyon Sud

location_facility: Vinzenz Krankenhaus - Department of Urology

location_facility: Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität

location_facility: Complejo Hospitalario Regional Virgen Del Rocio-Department Urology

location_facility: ATURO-Gemeinschaftspraxis für Urologie und Andrologie

location_facility: University College London Hospital (UCLH)

location_facility: Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia


title: Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey

acronym: PANORAMA

summary: The present European survey seeks to assess quality of life and satisfaction with treatment in people with T2DM and to appreciate disease and treatment variables including hypoglycaemia and level of glycaemic control. It will also provide relevant information on other important aspects such as the level of correlation of objective measures such as HbA1c with health status, QoL and satisfaction with current treatment. Overall 5000 randomly selected patients will be invited to participate from a representative sample of clinical practices during a pre-specified period. The study will entail a single patient visit. Patients who agree to the study and give their informed consent will complete questionnaires which, combined with retrospective notes review & an HbA1c test, will allow patient, disease and treatment variables to be collected. An HbA1c test is a finger prick test to measure glycosylated haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.

ReferenceCitation: Bradley C, Eschwege E, de Pablos-Velasco P, Parhofer KG, Simon D, Vandenberghe H, Gonder-Frederick L. Predictors of Quality of Life and Other Patient-Reported Outcomes in the PANORAMA Multinational Study of People With Type 2 Diabetes. Diabetes Care. 2018 Feb;41(2):267-276. doi: 10.2337/dc16-2655. Epub 2017 Nov 28.

publisher_dissemination: American Diabetes Association

ReferenceCitation: Simon D, de Pablos-Velasco P, Parhofer KG, Gonder-Frederick L, Duprat Lomon I, Vandenberghe H, Eschwege E, Bradley C. Hypoglycaemic episodes in patients with type 2 diabetes--risk factors and associations with patient-reported outcomes: The PANORAMA Study. Diabetes Metab. 2015 Dec;41(6):470-9. doi: 10.1016/j.diabet.2015.08.007. Epub 2015 Oct 9.

ReferenceCitation: de Pablos-Velasco P, Parhofer KG, Bradley C, Eschwege E, Gonder-Frederick L, Maheux P, Wood I, Simon D. Current level of glycaemic control and its associated factors in patients with type 2 diabetes across Europe: data from the PANORAMA study. Clin Endocrinol (Oxf). 2014 Jan;80(1):47-56. doi: 10.1111/cen.12119. Epub 2013 May 6.

publisher_dissemination: Wiley

ReferenceCitation: Bradley C, de Pablos-Velasco P, Parhofer KG, Eschwege E, Gonder-Frederick L, Simon D. PANORAMA: a European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus--study design. Prim Care Diabetes. 2011 Dec;5(4):231-9. doi: 10.1016/j.pcd.2011.04.004. Epub 2011 Jul 14.

location_country:
Germany
Ireland
Italy
United Kingdom
Netherlands
Spain
Greece
France


title: High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response

summary: The purpose of the study is to assess in a prospective series of patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET performed over (after 4 treatments), and at the end of the first-line treatment on progression-free survival at 2 years.

ReferenceCitation: Dupuis J, Berriolo-Riedinger A, Julian A, Brice P, Tychyj-Pinel C, Tilly H, Mounier N, Gallamini A, Feugier P, Soubeyran P, Colombat P, Laurent G, Berenger N, Casasnovas RO, Vera P, Paone G, Xerri L, Salles G, Haioun C, Meignan M. Impact of [(18)F]fluorodeoxyglucose positron emission tomography response evaluation in patients with high-tumor burden follicular lymphoma treated with immunochemotherapy: a prospective study from the Groupe d'Etudes des Lymphomes de l'Adulte and GOELAMS. J Clin Oncol. 2012 Dec 10;30(35):4317-22. doi: 10.1200/JCO.2012.43.0934. Epub 2012 Oct 29.

lead_sponsor: Lymphoma Study Association

location_country: Italy France

location_facility:
CHU Lyon Sud
Hôpital Necker
Centre Bergognié
Hôpital Saint-Louis
CHU Brabois
CHU de Dijon
CHU - Besançon
CHU Robert Debré
Institut Gustave Roussy
Ospedale Cuneo
Hôpital Pitié-Salpêtrière
CHRU Lille
CHU - Limoges
Clinique Victor Hugo
CHU - Nantes
Centre Hospitalier - Lens
CHU Purpan
Hôpital Henri Mondor
Centre Paoli-Calmettes
CHU Avicenne
Hôpital Bretonneau
Centre Henri Becquerel


title: Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone

summary:
This protocol (in patients aged 65 and over suffering from previously untreated multiple myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the number of patients analyzed and the implemented molecular diagnostics resources. The goal is to be able to identify patients who will best respond to the study treatments or experience the fewest associated side effects and improve prognosis, in order to optimize care management in multiple myeloma.

To this end, the study seeks to predict the following parameters in these patients:

The treatment response and occurrence of adverse events linked to a lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide combination.
Progression-free survival and overall survival.

Prediction of the treatment response and the occurrence of adverse effects will be based on:

An analysis of constitutive genetic traits linked to single nucleotide polymorphisms and DNA copy number variations.
An analysis of changes in the tumor's genotype (change in the DNA copy number) and phenotype (altered gene and micro-RNA expression).

Prediction of progression-free survival and overall survival will be based on an analysis of changes in the tumor's genotype and phenotype.

primary_purpose: Other

ReferenceCitation: Miannay B, Minvielle S, Roux O, Drouin P, Avet-Loiseau H, Guerin-Charbonnel C, Gouraud W, Attal M, Facon T, Munshi NC, Moreau P, Campion L, Magrangeas F, Guziolowski C. Logic programming reveals alteration of key transcription factors in multiple myeloma. Sci Rep. 2017 Aug 23;7(1):9257. doi: 10.1038/s41598-017-09378-9.

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

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

endpoint_id: HAL

repository_institution: HAL

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

lead_sponsor: Intergroupe Francophone du Myelome

location_facility:
Ch Dunkerque
CH Côte basque
Chu Nancy
Chu Rennes
Centre Antoine LACASSAGNE
René Huguenin
Institut Curie
Chu Nantes
CHU LYON
LYON SUD
CHU Dijon
CHR METZ
Chu Toulouse
CH Mulhouse
CHRU Lille
Chalon sur Saone
CHRU Angers
BORDEAUX
Chu Grenoble
Chu Poitiers
Chu Tours
Ipc Marseille
CH Yves Le Foll
CHD Vendée
CH ALBI
CH Blois


title: Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting

acronym: ENTERRA

summary:
The aim of this clinical trial is to assess the symptomatic efficacy and the impact on the utilization of healthcare resources of a treatment by gastric electrical stimulation (ENTERRA ®) in patients with refractory nausea and/or vomiting leading to a nutritional impairment. Eligible patients will be those with refractory symptoms either idiopathic, postsurgical or due to diabetes mellitus. The duration of the study will be 28 months for each patient.

After a run-in period of 4 months during which a prospective assessment of healthcare resources utilization and of the severity of the symptoms will be obtained, patients will be implanted. The follow-up period after implantation of the device will last 24 months in every patients and will be divided in two parts: a) After the first postoperative month during which the device will remained on the "OFF" position, the first phase of the study will be a randomized double-blind cross-over study with 2 periods of 4 months during which the device will be activated or not. After the 9th month of follow up, the trial will be an open trial and the device will be activated in all patients.

During the whole trial, patients will record all types of healthcare resources utilizations (hospitalizations, drug treatments, endoscopic procedures…) while the symptomatic efficacy of the treatment will be assessed by standard questionnaires at the following visits scheduled at 1, 5, 9, 12, 18, 24 months. The glycemic control will be determined at each visit in diabetic patients. A delayed gastric emptying will not be a selection criteria but we have planned to analyze the clinical results of the treatment in taking into account a delayed or normal gastric emptying during the pre-implantation period. Moreover, gastric emptying studies have been scheduled at 5, 9, 12 and 24 months to test the impact of gastric electrical stimulation on gastric emptying.

ReferenceCitation: Gourcerol G, Coffin B, Bonaz B, Hanaire H, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi P, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Ducrotte P, Guerci B; ENTERRA Research Group. Impact of Gastric Electrical Stimulation on Economic Burden of Refractory Vomiting: A French Nationwide Multicentre Study. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1857-1866.e1. doi: 10.1016/j.cgh.2020.11.011. Epub 2020 Nov 13.

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

ReferenceCitation: Ducrotte P, Coffin B, Bonaz B, Fontaine S, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi PE, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Gourcerol G, Guerci B; ENTERRA Research Group. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology. 2020 Feb;158(3):506-514.e2. doi: 10.1053/j.gastro.2019.10.018. Epub 2019 Oct 21.

lead_sponsor: University Hospital, Rouen

location_facility:
UH Clermont Ferrand
UH Grenoble
UH Rouen
UH Marseille
AP-HP Louis Mourier
UH Tours
AP-HP Jean Verdier
UH Lyon
UH Nimes
UH Montpellier
UH Toulouse
UH Lille
UH Strasbourg
UH Besancon
UH Poitiers
UH Nice
Corbeil Essones Hospital
UH Nantes
UH Bordeaux
UH Nancy
UH Rennes


title: A Phase II Study Evaluating the Association of Topotecan and Lapatinib in Early Recurrent (Less Than 12 Months)Ovarian or Peritoneal Cancer Patients After First Line of Platinum-Based Chemotherapy

acronym: TOPO-LAPA

summary: The objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.

lead_sponsor: Centre Francois Baclesse

collaborators: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
CHD Les Oudairies
CHU Jean MINJOZ
Centre Alexis vautrin
Centre G-F Leclerc
Centre Jean Bernard
Centre Paul Strauss
Institut Gustave Roussy
Institut Jean Godinot
Centre Antoine Lacassagne
Institut Claudius regaud
Hôpital Diaconesses
Centre Val d'Aurelle
Centre Paul Papin
Centre François Baclesse
Institut Bergonié
Institut de Cancérologie de la Loire
Centre Catherine de Sienne
APHP Hopital TENON
Centre azuréen de cancérologie
Centre René Gauducheau
Institut CURIE


title: Phase II Trial of Nivolumab for Pediatric and Adult Relapsing/Refractory Anaplastic Large Cell Lymphoma, for Evaluation of Response in Patients With Progressive Disease Cohort 1 or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse Cohort 2

acronym: NIVO-ALCL

summary: Prospective, non-randomized, single arm phase II trial with 2 cohorts of ALK+ ALCL treated with nivolumab

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Denmark Netherlands France

location_facility:
Rigshospitalet
BARBATI
IUC Toulouse
CHU de nancy
Centre Léon Berard Lyon
GROS
Hopital Saint Louis
CHU Toulouse Hopital des enfants
Gustave Roussy
Princess Maxima center
Landman-Parker
SIBON
CHU Bordeaux Hopital Pellegrin


title: Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register

summary:
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD).

This study aims to assess performance, clinical outcomes and safety

time_perspective: Other

lead_sponsor: Medicrea International

location_country: Poland Belgium France

location_facility:
Hopital la Timone
Centre Orthopédique Santy
CHU Estaing
Les Massues
Polyclinique
Orthopôle
Hopital Trousseau
La pitié Salepetrière Hospital
Hopital Saint Philibert
Hopitaux pediatriques - CHU Lenval
CH WAPI
Saint Etienne Hospital
Pr Andrzej Maciejczak


title: A Pilot, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase IIA Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 (40 and 80 mg Bid) as Adjunctive Therapy to Acetylcholinesterase Inhibitor Over a 3-month Period in Ambulatory Patients Suffering From Mild to Moderate Alzheimer's Disease (EHT 0202/002 Protocol)

summary: The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease.

lead_sponsor: Exonhit

location_facility: Purpan-Casselardit Hospital - University of Toulouse


title: Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia : A Prospective Study for a Blood Diagnostic Test in Alzheimer's Disease - (Protocol n° EHTAD/002).

summary: The objective of the study is to define the performance of blood-based signatures for Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and non-demented controls.

primary_purpose: Diagnostic


title: Study of ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 59 Years With High Risk Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 2-3)

summary: This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma

ReferenceCitation: Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Ferme C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. doi: 10.1200/JCO.2005.09.131. Epub 2005 May 2.

ReferenceCitation: Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.

ReferenceCitation: Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. doi: 10.1182/blood-2003-02-0542. Epub 2003 Aug 14.

ReferenceCitation: Ghesquieres H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.

ReferenceCitation: Copie-Bergman C, Cuilliere-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Fitoussi O, Belhadj K, Mounier N, Parrens M, Tilly H, Salles G, Feugier P, Ferme C, Ysebaert L, Gabarre J, Herbrecht R, Janvier M, Van Den Neste E, Morschhauser F, Casasnovas O, Ghesquieres H, Anglaret B, Brechignac S, Haioun C, Gisselbrecht C. Survival impact of rituximab combined with ACVBP and upfront consolidation autotransplantation in high-risk diffuse large B-cell lymphoma for GELA. Haematologica. 2011 Aug;96(8):1136-43. doi: 10.3324/haematol.2010.038109. Epub 2011 May 5.

location_country: Switzerland Belgium France

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud

location_facility: Schweirische Arbeitsgruppe fur klinische Krebsforschung


acronym: INOVA

summary: This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).

ReferenceCitation: Borg C, Andre T, Mantion G, Boudghene F, Mornex F, Maingon P, Adenis A, Azria D, Piutti M, Morsli O, Bosset JF. Pathological response and safety of two neoadjuvant strategies with bevacizumab in MRI-defined locally advanced T3 resectable rectal cancer: a randomized, noncomparative phase II study. Ann Oncol. 2014 Nov;25(11):2205-2210. doi: 10.1093/annonc/mdu377. Epub 2014 Aug 13.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_facility: Ch Lyon Sud; Radiotherapie Sct Jules Courmont

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Centre Val Aurelle Paul Lamarque; Radiotherapie

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

location_facility: Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie

location_facility: Polyclinique Du Parc; Centre De Hautes Energies

location_facility: Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale

location_facility: Centre Hospitalier Andre Boulloche; Departement D'Oncologie

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Hopital Saint Louis; Radiotherapie Oncologie

title: Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study


title: Phase II-III Study Comparing Radiochemotherapy With the FOLFOX Regimen Versus Radiochemotherapy With 5FU-cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Oesophageal Cancer.

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, 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) together with radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different combination chemotherapy regimens to compare how well they work as first-line therapy in treating patients with esophageal cancer that cannot be removed by surgery.

ReferenceCitation: Winter A, Cuer B, Conroy T, Juzyna B, Gourgou S, Mollevi C, Touraine C. Flexible modeling of longitudinal health-related quality of life data accounting for informative dropout in a cancer clinical trial. Qual Life Res. 2023 Mar;32(3):669-679. doi: 10.1007/s11136-022-03252-6. Epub 2022 Sep 17.

ReferenceCitation: Cuer B, Conroy T, Juzyna B, Gourgou S, Mollevi C, Touraine C. Joint modelling with competing risks of dropout for longitudinal analysis of health-related quality of life in cancer clinical trials. Qual Life Res. 2022 May;31(5):1359-1370. doi: 10.1007/s11136-021-03040-8. Epub 2021 Nov 24.

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

ReferenceCitation: Cuer B, Mollevi C, Anota A, Charton E, Juzyna B, Conroy T, Touraine C. Handling informative dropout in longitudinal analysis of health-related quality of life: application of three approaches to data from the esophageal cancer clinical trial PRODIGE 5/ACCORD 17. BMC Med Res Methodol. 2020 Sep 3;20(1):223. doi: 10.1186/s12874-020-01104-w.

ReferenceCitation: Conroy T, Galais MP, Raoul JL, Bouche O, Gourgou-Bourgade S, Douillard JY, Etienne PL, Boige V, Martel-Lafay I, Michel P, Llacer-Moscardo C, Francois E, Crehange G, Abdelghani MB, Juzyna B, Bedenne L, Adenis A; Federation Francophone de Cancerologie Digestive and UNICANCER-GI Group. Definitive chemoradiotherapy with FOLFOX versus fluorouracil and cisplatin in patients with oesophageal cancer (PRODIGE5/ACCORD17): final results of a randomised, phase 2/3 trial. Lancet Oncol. 2014 Mar;15(3):305-14. doi: 10.1016/S1470-2045(14)70028-2. Epub 2014 Feb 18. Erratum In: Lancet Oncol. 2014 Dec;15(13):e587. Lancet Oncol. 2014 Dec;15(13):e587.

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

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

location_facility: Centre Hospital Regional Universitaire de Limoges


lead_sponsor: Nantes University Hospital

summary: The main objective of the study is to improve outcome of younger patients (between 18-60 years) with acute myeloid leukemia and intermediate risk defined by the cytogenetics. In this population, in the absence of bone marrow transplantation, event free survival (EFS) is estimated at 35% after three years of follow-up. Adjunction of gemtuzumab ozogamycin (MYLOTARG®) to standard chemotherapy is supposed to increase EFS up to 50% at 3 years. To test this hypothesis, the Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang (GOELAMS ) sponsored by Nantes University Hospital leads this randomized open phase III trial in 29 French centers.

sponsor_collaborators:
Nantes University Hospital
Chugai Pharmaceutical
French Innovative Leukemia Organisation

location_facility:
CH Muller
CH Avignon
CHU du Bocage
CH Metz Thionvile
CHU Amiens
Centre Hospitalier de la Côte Basque
CHU Brabois
CHU Carémeau
CHU Morvan
CH La Source
CHU Lapeyronie
CHU Robert Debré
CHU du Haut Lévèque
CHU Dupuytren
Institut Paoli Calmette
CH Louis Pasteur
CHU Jean Bernard - La Milétrie
CHU Pontchaillou
CHU Hautepierre
CHRU Angers
CHU Hôpital Minjoz
CH Pays d'Aix
CHU Purpan
CHU Michallon
Institut de Cancérologie de la Loire
Hopital Cochin (AP-HP)
CHU Hôtel Dieu
CHU Bretonneau

title: Randomized Open Phase III Trial Testing Efficacy of Gemtuzumab Ozogamycin (MYLOTARG) Associated to Intensive Chemotherapy for Patients Aged Between 18-60 Years and Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk


lead_sponsor: Pierre Fabre Medicament

summary: The purpose of this study is to demonstrate the efficacy of 0.2 % digluconate chlorhexidine mouthwash in the prevention of alveolar osteitis following third molar extraction and to evaluate the safety and local tolerability.

title: Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction

location_country: Latvia Estonia Lithuania France


title: Compassionate Use Access to REP 2139-Mg for the Treatment of Chronic HBV Infection or Chronic HBV / HDV Co-infection

acronym: RCAP

summary:
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to response to other other antiviral agents either approved or under development and who are in danger of progressing to decompensated cirrhosis.

This compassionate access program will provide access to a once weekly regimen of subcutaneously (SC) administered REP 2139-Mg for a period of 48 weeks with the goal of achieving functional cure of HDV and or HBV, with the reversal of liver disease in the absence of antiviral therapy. The safety, tolerability and efficacy of SC REP 2139-Mg will be monitored during and after therapy

status: Available

study_type: Expanded Access

ReferenceCitation: Vaillant A. REP 2139: Antiviral Mechanisms and Applications in Achieving Functional Control of HBV and HDV Infection. ACS Infect Dis. 2019 May 10;5(5):675-687. doi: 10.1021/acsinfecdis.8b00156. Epub 2018 Oct 5.

ReferenceCitation: Blanchet M, Sinnathamby V, Vaillant A, Labonte P. Inhibition of HBsAg secretion by nucleic acid polymers in HepG2.2.15 cells. Antiviral Res. 2019 Apr;164:97-105. doi: 10.1016/j.antiviral.2019.02.009. Epub 2019 Feb 13.

ReferenceCitation: Boulon R, Blanchet M, Lemasson M, Vaillant A, Labonte P. Characterization of the antiviral effects of REP 2139 on the HBV lifecycle in vitro. Antiviral Res. 2020 Nov;183:104853. doi: 10.1016/j.antiviral.2020.104853. Epub 2020 Jun 23.

ReferenceCitation: Bazinet M, Pantea V, Cebotarescu V, Cojuhari L, Jimbei P, Albrecht J, Schmid P, Le Gal F, Gordien E, Krawczyk A, Mijocevic H, Karimzadeh H, Roggendorf M, Vaillant A. Safety and efficacy of REP 2139 and pegylated interferon alfa-2a for treatment-naive patients with chronic hepatitis B virus and hepatitis D virus co-infection (REP 301 and REP 301-LTF): a non-randomised, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2017 Dec;2(12):877-889. doi: 10.1016/S2468-1253(17)30288-1. Epub 2017 Sep 28. Erratum In: Lancet Gastroenterol Hepatol. 2018 Jan;3(1):e1.

ReferenceCitation: Bazinet M, Pantea V, Cebotarescu V, Cojuhari L, Jimbei P, Anderson M, Gersch J, Holzmayer V, Elsner C, Krawczyk A, Kuhns MC, Cloherty G, Dittmer U, Vaillant A. Persistent Control of Hepatitis B Virus and Hepatitis Delta Virus Infection Following REP 2139-Ca and Pegylated Interferon Therapy in Chronic Hepatitis B Virus/Hepatitis Delta Virus Coinfection. Hepatol Commun. 2020 Nov 13;5(2):189-202. doi: 10.1002/hep4.1633. eCollection 2021 Feb.

ReferenceCitation: Bazinet M, Pantea V, Placinta G, Moscalu I, Cebotarescu V, Cojuhari L, Jimbei P, Iarovoi L, Smesnoi V, Musteata T, Jucov A, Dittmer U, Krawczyk A, Vaillant A. Safety and Efficacy of 48 Weeks REP 2139 or REP 2165, Tenofovir Disoproxil, and Pegylated Interferon Alfa-2a in Patients With Chronic HBV Infection Naive to Nucleos(t)ide Therapy. Gastroenterology. 2020 Jun;158(8):2180-2194. doi: 10.1053/j.gastro.2020.02.058. Epub 2020 Mar 6.

lead_sponsor: Replicor Inc.

location_country: France Italy Austria Turkey Israel

location_facility: Centre Hospitalier Universitaire de Montpellier


title: Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE (Titanium) Manufactured by MEDICREA®

acronym: C-CURVE

summary:
This study includes one type of product named C-CURVE which is a Stand-alone Cervical Interbody Cage. This product is available in two materials: PEEK and Titanium.

The C-Curve Cervical Interbody Devices is one single implant used for insertion between two adjacent vertebrae (cervical spine). C-Curve has been designed to restore and/or maintain adequate interbody height, and thus help stabilize one or more cervical levels while fusion occurs. This system has also as objectives to increase of the quality of life, decrease patient's pain and decrease a potential dysphagia (clinical performances). This system must only be used in the cervical spine.

This post-market clinical follow-up (PMCF) study aims to confirm the acceptable benefits/risk profile of the device for the patients and to fill essential requirements to maintain the CE mark through a clinical evaluation.

ReferenceCitation: Alimi M, Njoku I, Hofstetter CP, Tsiouris AJ, Kesavabhotla K, Boockvar J, Navarro-Ramirez R, Hartl R. Anterior Cervical Discectomy and Fusion (ACDF): Comparison Between Zero Profile Implants and Anterior Cervical Plate and Spacer. Cureus. 2016 Apr 17;8(4):e573. doi: 10.7759/cureus.573.

ReferenceCitation: Azab W, Abdel-Razek M, Ali A, Abdelrahman A, Salaheldin W, Nasim K, Attia H, Soliman D. Outcome evaluation of a zero-profile implant for anterior cervical diskectomy with fusion. Turk Neurosurg. 2012;22(5):611-7. doi: 10.5137/1019-5149.JTN.5646-11.2.

ReferenceCitation: Barbagallo GM, Romano D, Certo F, Milone P, Albanese V. Zero-P: a new zero-profile cage-plate device for single and multilevel ACDF. A single institution series with four years maximum follow-up and review of the literature on zero-profile devices. Eur Spine J. 2013 Nov;22 Suppl 6(Suppl 6):S868-78. doi: 10.1007/s00586-013-3005-0. Epub 2013 Sep 24.

ReferenceCitation: Bucci MN, Oh D, Cowan RS, Davis RJ, Jackson RJ, Tyndall DS, Nehls D. The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes. Med Devices (Auckl). 2017 Apr 18;10:61-69. doi: 10.2147/MDER.S127133. eCollection 2017.

ReferenceCitation: Chen Y, Liu Y, Chen H, Cao P, Yuan W. Comparison of Curvature Between the Zero-P Spacer and Traditional Cage and Plate After 3-Level Anterior Cervical Discectomy and Fusion: Mid-term Results. Clin Spine Surg. 2017 Oct;30(8):E1111-E1116. doi: 10.1097/BSD.0000000000000440.

ReferenceCitation: De Leo-Vargas RA, Munoz-Romero I, Mondragon-Soto MG, Martinez-Anda JJ. Locking Stand-Alone Cage Constructs for the Treatment of Cervical Spine Degenerative Disease. Asian Spine J. 2019 Apr 10;13(4):630-637. doi: 10.31616/asj.2018.0234. Print 2019 Aug.

ReferenceCitation: Lee YS, Kim YB, Park SW. Does a zero-profile anchored cage offer additional stabilization as anterior cervical plate? Spine (Phila Pa 1976). 2015 May 15;40(10):E563-70. doi: 10.1097/BRS.0000000000000864.

ReferenceCitation: Li Z, Zhao Y, Tang J, Ren D, Guo J, Wang H, Li L, Hou S. A comparison of a new zero-profile, stand-alone Fidji cervical cage and anterior cervical plate for single and multilevel ACDF: a minimum 2-year follow-up study. Eur Spine J. 2017 Apr;26(4):1129-1139. doi: 10.1007/s00586-016-4739-2. Epub 2016 Aug 23.

ReferenceCitation: Lu Y, Bao W, Wang Z, Zhou F, Zou J, Jiang W, Yang H, Zhang Z, Zhu X. Comparison of the clinical effects of zero-profile anchored spacer (ROI-C) and conventional cage-plate construct for the treatment of noncontiguous bilevel of cervical degenerative disc disease (CDDD): A minimum 2-year follow-up. Medicine (Baltimore). 2018 Feb;97(5):e9808. doi: 10.1097/MD.0000000000009808.

ReferenceCitation: Nambiar M, Phan K, Cunningham JE, Yang Y, Turner PL, Mobbs R. Locking stand-alone cages versus anterior plate constructs in single-level fusion for degenerative cervical disease: a systematic review and meta-analysis. Eur Spine J. 2017 Sep;26(9):2258-2266. doi: 10.1007/s00586-017-5015-9. Epub 2017 Mar 10.

ReferenceCitation: Scholz M, Schelfaut S, Pingel A, Schleicher P, Kandziora F. A cervical "zero-profile" cage with integrated angle-stable fixation: 24-months results. Acta Orthop Belg. 2014 Dec;80(4):558-66.

location_facility: Centre de consultations spécialisées de la Sauvegarde


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.

lead_sponsor: Hoffmann-La Roche


title: Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

acronym: Neo-PDGF

summary: Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.

ReferenceCitation: Martinez F, Kamar N, Pallet N, Lang P, Durrbach A, Lebranchu Y, Adem A, Barbier S, Cassuto-Viguier E, Glowaki F, Le Meur Y, Rostaing L, Legendre C, Hermine O, Choukroun G; NeoPDGF Study Investigators. High dose epoetin beta in the first weeks following renal transplantation and delayed graft function: Results of the Neo-PDGF Study. Am J Transplant. 2010 Jul;10(7):1695-700. doi: 10.1111/j.1600-6143.2010.03142.x.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Nantes, Hotel-Dieu Hospital
RANGUEIL Hospital
Georges Pompidou European Hospital
CHU Nice, Pasteur Hospital
TENON Hospital
LA CAVALE BLANCHE Hospital
Bois Guillaume Hospital
LA MILETRIE Hospital
FOCH Hospital
ALBERT CALMETTE Hospital
BRETONNEAU Hospital
MAISON BLANCHE Hospital
Kremlin Bicêtre Hospital
Necker Hospital
MICHALLON Hospital
Amiens hospital
MONDOR Hospital


title: Profile of Hypertensive Patients Aged of 75 Years and Older Seen in General Practitioner According to Their Renal Damage.

acronym: SERENITE

summary: Describe the clinical characteristics of hypertensive patients aged of 75 years and older seen in general practitioner consultation according to their renal damage

lead_sponsor: AstraZeneca


title: A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer

summary: The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.

lead_sponsor: Boehringer Ingelheim

location_facility:
1239.2.3301J Hôpital Saint Antoine
1239.2.3303A Institut Gustave Roussy
1239.2.3301F Hôpital Saint Antoine
1239.2.3301I Hôpital Saint Antoine
1239.2.3301A Hôpital Saint Antoine
1239.2.3303F Institut Gustave Roussy
1239.2.3301H Hôpital Saint Antoine
1239.2.3303C Institut Gustave Roussy
1239.2.3305A clinique Saint Jean
1239.2.3304B Hôpital Robert Debré
1239.2.3302B Hôpital Tenon
1239.2.3301C Hôpital Saint Antoine
1239.2.3303E Institut Gustave Roussy
1239.2.3301D Hôpital Saint Antoine
1239.2.3304C Hôpital Robert Debré
1239.2.3302A Hôpital Tenon
1239.2.3301G Hôpital Saint Antoine
1239.2.3301E Hôpital Saint Antoine
1239.2.3304A Hôpital Robert Debré
1239.2.3301K Hôpital Saint Antoine
1239.2.3301B Hôpital Saint Antoine
1239.2.3305B Cabinet Médical
1239.2.3303B Institut Gustave Roussy
1239.2.3303D Institut Gustave Roussy


title: Maverick Total Disc Replacement in a 'Real World' Patient Population - A Prospective, Multicenter, Observational Study

acronym: Maverick

summary: The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.

lead_sponsor: Medtronic Spinal and Biologics

location_country: Germany Canada France

location_facility: CH Antoine Béclère - Service de Chirurgie Orthopédique

location_facility: CH de Meulan - Service de Chirurgie Orthopédique

location_facility: Service de Chirurgie Orthopédique, AP-HP, Hôpital Beaujon

location_facility: CH Lariboisière, Service de Neurochirurgie

location_facility: Praxis für Orthopädie und Neurochirurgie Potsdam

location_facility: Clinique de Neurochirurgie Hôpital Roger Salengro


title: A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia

summary: This study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine. Additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine. It is a single arm study and has no comparator.

lead_sponsor: Genzyme, a Sanofi Company

sponsor_collaborators:
Genzyme, a Sanofi Company
Bioenvision

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
France


summary: The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T < or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC.

ReferenceCitation: Besse B, Mazieres J, Ribassin-Majed L, Barlesi F, Bennouna J, Gervais R, Moreau L, Berard H, Debieuvre D, Molinier O, Moro-Sibilot D, Souquet PJ, Jacquot S, Petit L, Lena H, Pignon JP, Lacas B, Morin F, Milleron B, Zalcman G, Soria JC; Intergroupe Francophone de Cancerologie Thoracique (IFCT). Pazopanib or placebo in completely resected stage I NSCLC patients: results of the phase II IFCT-0703 trial. Ann Oncol. 2017 May 1;28(5):1078-1083. doi: 10.1093/annonc/mdx070.

location_facility:
Paris - Hopital Tenon
Caen - CHU Côte de Nacre
Le Mans - Centre Hospitalier
Moulins - CH
Strasbourg - NHC
Toulouse - CHU Larrey
Nancy - CHU
Boulogne - Ambroise Paré
Bordeaux - Polyclinique Nord
Villejuif - Institut Gustave Roussy
Paris - hôpital Saint-Antoine
Pau - CH
Lyon Sud
Nantes - Centre René Gauducheau
Montpellier - Clinique Clémentville
Orléans - CH
Béziers - CH
Lille - Hôpital Calmette
Metz - Clinique Claude Bernard
Mont de Marsan - CH
Caen - Centre François Baclesse
Colmar - CH
Clermont Ferrand - CHU
Toulon - HIA
Clamart - Hôpital Percy
Mantes La Jolie - CH
Nevers - CH
Dax - CH
Vesoul - CHI
Annemasse - CH
Montpellier - CHRU
Paris - Saint Louis
Marseille - Hôpital Sainte Marguerite
Thonon les bains - CH
Reims - CHU
CHU
Rennes - CHU
Bobigny - Hôpital Avicenne
Grenoble - CHU
Centre Catalan d'Onologie

title: A Randomized, Double-blind, Placebo-controlled Phase II-III Multi-centre Study to Evaluate the Effect of Adjuvant Pazopanib (GW786034) Versus Placebo on Post-surgical Disease-free Survival in Patients With Stage I Non Small Cell Lung Cancer and Tumor Size Equal or Inferior to 5 cm.


title: Phase III Study Evaluating the Use of Systemic Chemotherapy and Chemohyperthemia Intraperitoneal Preoperatively (CHIP) and After Maximum Resection of Peritoneal Carcinomatosis Originating With Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether systemic chemotherapy is more effective with or without intraperitoneal chemohyperthermia in treating patients with peritoneal carcinomatosis from colorectal cancer.

PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it works compared with or without intraperitoneal chemohyperthermia in treating patients undergoing surgery for peritoneal carcinomatosis from colorectal cancer.

ReferenceCitation: Quenet F, Elias D, Roca L, Goere D, Ghouti L, Pocard M, Facy O, Arvieux C, Lorimier G, Pezet D, Marchal F, Loi V, Meeus P, Juzyna B, de Forges H, Paineau J, Glehen O; UNICANCER-GI Group and BIG Renape Group. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):256-266. doi: 10.1016/S1470-2045(20)30599-4. Epub 2021 Jan 18.

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

lead_sponsor: UNICANCER


title: Open-Label Study To Evaluate The EULAR-RAID Score, Rheumatoid Arthritis Impact Of Disease Score, In Rheumatoid Arthritis Patients Eligible To Etanercept And Who Will Receive Etanercept

acronym: Rainbow

summary: The Disease Activity Score (DAS) is a system of measurement developed in the 1980s that uses certain criteria, including joint counts and patient perceived disease activity, to measure disease activity in people with Rheumatoid Arthritis . More recently, the European League against Rheumatism (EULAR) has developed a new system of measurement known as the Rheumatoid Arthritis Impact of Disease score, or EULAR-RAID score. The EULAR-RAID score is a composite score based on patient reported outcomes, and includes such criteria as pain, functional disability, fatigue, sleep disturbances, coping, overall assessment of physical well being and overall assessment of psychological well being. The objective of this study is to evaluate the practical modalities and performance of the EULAR- RAID score in patients with rheumatoid arthritis who have been prescribed etanercept as part of usual medical practice.

ReferenceCitation: Duarte C, Santos EJF, Ferreira RJO, Kvien TK, Dougados M, de Wit M, da Silva JAP, Gossec L. Validity and reliability of the EULAR instrument RAID.7 as a tool to assess individual domains of impact of disease in rheumatoid arthritis: a cross-sectional study of 671 patients. RMD Open. 2021 Feb;7(1):e001539. doi: 10.1136/rmdopen-2020-001539.

ReferenceCitation: Dougados M, Brault Y, Logeart I, van der Heijde D, Gossec L, Kvien T. Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the Rheumatoid Arthritis Impact of Disease (RAID). Arthritis Res Ther. 2012 May 30;14(3):R129. doi: 10.1186/ar3859.

ReferenceCitation: Dougados M, Ripert M, Hilliquin P, Brocq O, Brault Y, Logeart I. Onset of action of etanercept in rheumatoid arthritis based on patient-reported outcomes. Clin Exp Rheumatol. 2012 Mar-Apr;30(2):266-8. Epub 2012 Apr 13.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

collaborators: Lincoln Medical and Mental Health Center

location_country: Monaco France


title: Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV)

acronym: Score-TIH

summary:
Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.

During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.

ReferenceCitation: Tardy-Poncet B, de Maistre E, Pouplard C, Presles E, Alhenc-Gelas M, Lasne D, Horellou MH, Mouton C, Serre-Sapin A, Bauters A, Nguyen P, Mullier F, Perrin J, Le Gal G, Morange PE, Grunebaum L, Lillo-Le Louet A, Elalamy I, Gruel Y, Greinacher A, Lecompte T, Tardy B; GFHT-HIT study group. Heparin-induced thrombocytopenia: Construction of a pretest diagnostic score derived from the analysis of a prospective multinational database, with internal validation. J Thromb Haemost. 2021 Aug;19(8):1959-1972. doi: 10.1111/jth.15344. Epub 2021 Jun 14.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Groupe d'étude sur l'Hémostase et la Thrombose

collaborators: Association Française des centres régionaux de Pharmacovigilance

location_facility: Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie

location_facility: Laboratoire d'hématologie - CHU de Clermont Ferrand

location_facility: Hôpital BICHAT - Service d'hématologie immunologie

location_facility: Hôpital Européen Georges Pompidou - Service Hématologie Biologique A

location_facility: CHU Strasbourg Hautepierre Laboratoire d'Hématologie

location_facility: Hôpital Antoine Beclère - Laboratoire d'hématologie

location_facility: G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran

location_facility: Laboratoire d'Hématologie - CHU le Bocage

location_facility: HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie

location_facility: ETS de Franche Conté - Laboratoire d'Immuno Hématologie

location_facility: Laboratoire d'hématologie - Hôpital Louis Pradel

location_facility: Hopital Purpan - Laboratoire d'hématologie

location_facility: CHU Trousseau - CTH - Service d'Hématologie Hémostase

location_facility: Laboratoire central d'hématologie - Hôpital R. DEBRE

location_facility: Hôpital Necker Enfants Malades -Laboratoire d'Hématologie

location_facility: Hôpital Cardiologique - Laboratoire d'Hémostase

location_facility: CHU Cavale Blanche Laboratoire d'Hématologie


title: A Phase II Trial With Pemetrexed Plus Cisplatin as First Line Chemotherapy for Advanced Non - Small Cell Lung Cancer (NSCLC) Patients With Measurable Asymptomatic Brain Metastasis (GFPC 07-01/METAL).

summary:
NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of these patients in this situation is based on supportive care and whole-brain radiotherapy. The place of chemotherapy for patients with good performance status was discussed for a long time and it is now admitted. However, the place of new drugs such as pemetrexed, which is currently used as a second line treatment for NSCLC, needs to be further studied. It is known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar effectiveness when compared to other drugs associations commonly used in this indication. In addition, Cisplatin with Pemetrexed probably present a better safety profile.

The present study is based upon the hypothesis stipulating that the association cisplatin-pemetrexed will be at least as efficient as the others association currently used for treatment of NSCLC and will present a better safety profile. The primary objective of this study is overall response rate on brain metastasis according to RECIST criteria. Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms, overall survival.

The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II study with the possibility of stopping the study early because of lack of efficacy.

lead_sponsor: University Hospital, Brest

location_facility: Service Pneumologie, Pavillon 1A, CH de Lyon-Sud

location_facility: Centre Hospitalier René Dubos - Pontoise, Service d'Oncologie - Hématologie Clinique

location_facility: Centre Hospitalier, Service de Pneumologie

location_facility: Centre Hôspitalier du Pays d'Aix, Service des Maladies Respiratoires

location_facility: Hôpital A. Mignot, Service de Pneumologie

location_facility: CHU brest, institut de cancérologie et d'hématologie

location_facility: Serv. de Pneumo-Allergo, CH de Martigues

location_facility: Médecine 4, C.H.G. de la Fontonne Antibes

location_facility: CHU de ROUEN, Hôpital Bois Guillaume, Serv. de Pneumo.

location_facility: Centre Hôspitalier, Service de Pneumo-Neuro

location_facility: Hôpital Pontchailloux, Service de Pneumologie.

location_facility: Centre Hospitalier Départemental, Service de Pneumologie,

location_facility: Pneumologie, Centre hôspitalier, DRAGUIGNAN


title: A Phase III Multicentre Randomised Double-blind Comparative Study of Efficacy and Safety of Lanreotide 30 mg Versus Placebo for Treatment of Patients With Digestive Fistulae

summary: The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.

ReferenceCitation: Gayral F, Campion JP, Regimbeau JM, Blumberg J, Maisonobe P, Topart P, Wind P; Lanreotide Digestive Fistula. Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae. Ann Surg. 2009 Dec;250(6):872-7. doi: 10.1097/sla.0b013e3181b2489f.

lead_sponsor: Ipsen

location_country:
Russian Federation
France

location_facility: Institute of Surgery n.a. A.V. Vishnevsky


title: A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

summary: The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Limited

location_country:
Germany
Italy
Portugal
Denmark
Spain
Russian Federation
France

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital Universitari Sagrat Cor Quironsalud

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia

location_facility: Ospedale Santa Maria Della Misericordia Di Perugia

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Regional Treatment and Rehabilitation Center

location_facility: Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: City Clinical Hospital #1 n.a. N.I.Pirogov

location_facility: Moscow State Medical Stomatological University n.a. A.I. Evdokimov

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Centre de consultations Saint-Jean Bâtiment A

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo