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