FDRK - Roadmap for Colon Cancer

Head :
Abenhaim Lucien, INSERM U657

Last update : 07/10/2014 | Version : 1 | ID : 6922

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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 Roadmap for Colon Cancer
Sign or acronym FDRK
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL: 16/03/2006
General Aspects
Medical area Cardiology
Health determinants Nutrition
Others (details) Colon cancer
Keywords tumour progression, metastasis, primary metastatic disease, local tumour recurrence, Health episodes, death
Scientific investigator(s) (Contact)
Name of the director Abenhaim
Surname Lucien
Address 75014 PARIS
Email contact@la-ser.com
Unit INSERM U657
Organization LASER
Collaborations
Funding
Funding status Mixed
Details APPEL D'OFFRE ROCHE
Governance of the database
Sponsor(s) or organisation(s) responsible Laser
Organisation status Private
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 No
Additional information regarding sample selection. Inclusion method: Prospective Other bodies active in creating this cohort: CHU, CHG, CANCER TREATMENT CENTRES, PRIVATE NON-PROFIT HOSPITALS PARTICIPATING IN PUBLIC HOSPITAL SERVICE (PSPH) AND PRIVATE CLINICS.
Database objective
Main objective General Objective 1. To describe treatment methods in France for 1,360 patients with colorectal cancer diagnosed between 2006 and 2008 2. To describe overall survival at 5 years according to initial treatment methods Secondary objectives: - To describe target populations and chemotherapy usage patterns; - To describe usage patterns for different centres; - To describe the "outcomes" after 12, 36 and 60 months: progression-free survival and quality of life.
Inclusion criteria - Primary adenocarcinoma of the colon or upper rectum with histological confirmation (> 10 cm from the anal margin, subperitoneal upper rectum included); - Incident cases (histological diagnosis of colon cancer)
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 Multicentric cohort throughout France (97 centres)
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 06/2006
Date of last collection (YYYY or MM/YYYY) 05/2013
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 1360
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Data collection method Self-administered questionnaire: Entry from a paper questionnaire (Manual input) Clinical examination: Handwritten (Manual input)
Participant monitoring Yes
Details on monitoring of participants Follow-up duration: 5 years
Links to administrative sources Yes
Linked administrative sources (detail) Database(s) used: CépiDc
Promotion and access
Promotion
Link to the document http://www.nature.com/bjc/journal/v81/n1/abs/6690651a.html
Link to the document http://www.nature.com/bjc/journal/v81/n1/abs/6690651a.html
Access
Terms of data access (charter for data provision, format of data, availability delay) Data may be used by academic teams: access for all doctoral students accepted into a high-level team (INSERM). Data may be used by industrial teams: Access to aggregate and anonymised data at ROCHE
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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