- FREGAT

Head :
Mariette Christophe

Last update : 06/28/2014 | Version : 2 | ID : 8468

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name FREGAT
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation Accord CPP (10 décembre 2013) , ANSM (13 janvier 2014) ,CCTIRS (12 mars 2014) CNIL (23 décembre 2014)
General Aspects
Medical area Cancer research
Health determinants Iatrogenic
Nutrition
Keywords Tumour of the oesophagus, stomach tumour, diseases of the oesophagus, digestive system diseases, gastroesophageal cancer, digestive system, clinical and biological records, surgery
Scientific investigator(s) (Contact)
Name of the director Mariette
Surname Christophe
Address Hôpital Huriez -3ème EST- Chirurgie Digestive et Générale- CHRU de Lille - place de verdun 59037 Lille cedex
Phone +33 (0)3 20 44 44 07
Email christophe.mariette@chru-lille.fr
Organization CHRU
Collaborations
Funding
Funding status Public
Details appel à projet INCa 2012
Governance of the database
Sponsor(s) or organisation(s) responsible CHRU Lille
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study Yes
Details Performed at individual level
Additional information regarding sample selection. All newly diagnosed patients in participating centres with gastro-oesophageal treatment-naive cancer will be included after acceptance and signed consent, whether they undergo surgery or not, regardless of histological type, tumour stage or therapeutic strategy. Exclusion criteria: - Men or women under the age of 18. - People deprived of liberty or under guardianship (including temporary guardianship). - People who do not speak French. - Adults unable to express their consent. - Patients already included in the FREGAT database. - Patients who refuse to participate.
Database objective
Main objective Main Objective: To identify, through the creation of a clinico-biological, prospective, multicentric French database, the clinical, biological and tumour factors linked to anti-tumour therapy resistance in patients treated for stage I to IV oesophageal or stomach cancer. Secondary Objectives: - To assess the impact of different current therapeutic strategies for recurrence, survival and quality of life. - To identify predictive factors for patient treatment resistance in order to identify the most efficient and least toxic therapeutic combination. - To describe individual, social and behavioural characteristics of patients included in the study. - To identify individual and collective determinants that influence possible access to care and initiation of treatment. - To identify new prognostic and predictive relapse factors.
Inclusion criteria - Men or women ≥ 18 ans. - Presenting with oesophageal or gastro-oesophageal junction carcinoma recently diagnosed by biopsy, regardless of cancer subtype, tumour stage or proposed treatment. - Treatment-naive cancer. - Have given clear and written consent for blood samples, various questionnaires and the collection of patient information. N.B.: Patients participating in a clinical trial can be included in the FREGAT trial. There is no exclusion period.
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area Metropolitan France (33 centres, 46 teams)
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2014
Size of the database
Size of the database (number of individuals) Greater than 20 000 individuals
Details of the number of individuals 135 patients au 20/01/2015
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Biological data
Administrative data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Biological data (detail) - a collection of tumour samples (pre-treatment biopsies. post-treatment biopsies, surgical specimens) collected in accordance with current quality charters. These samples will be stored in the corresponding investigation centre. Samples will ideally be frozen. However, paraffin conservation will also be acceptable. - blood sample collection to be put in place in 6 centres with high recruitment potential that have a Biological Resource Centre (CRB) (approximately 3,000 patients). These approved CRBs will ensure sample quality control as per usual.
Administrative data (detail) The investigating party will issue the patient a FREGAT cohort registration form to be completed by the patient and posted to the Caen Cancéropôle Nord-Ouest Data Processing Centre (CTD/CNO).
Presence of a biobank Yes
Contents of biobank Whole blood
Serum
Plasma
Tissues
Details of biobank content Consult the scientist in charge (Professor Christophe MARIETTE)
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception
Others
Care consumption (detail) Hospitalization
Medical/paramedical consultation
Medicines consumption
Other (detail) socio-economic questionnaire.
Procedures
Data collection method The collection of clinical, biological and epidemiological data as well as the characteristics of patient treatment will be stored in the electronic case report form (e-CRF) for the study
Participant monitoring Yes
Details on monitoring of participants Follow-up for 3 years after inclusion. All information in the database is gathered during patient clinical follow-up, according to usual visit and follow-up practices in each investigating centre. Annual updates to information is required systematically. Updates to information regarding events such as death or recurrence will be also required.
Links to administrative sources Yes
Promotion and access
Promotion
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/25062398
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/25012732
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/24919373
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/24075273
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/23313257
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/23064779
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/22005144
Access
Terms of data access (charter for data provision, format of data, availability delay) Publication or presentation of results from this trial is not permitted without prior agreement from the sponsor (CHRU de Lille) and coordinating researcher (Prof. Christophe MARIETTE).
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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