ITMO public health
Last update : 12/01/2017 | Version : 2 | ID : 60029
| General | |
| Identification | |
| Detailed name | Cancer and Increased Risk Associated with Inflammatory Bowel Disease in France |
| Sign or acronym | CESAME |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL 784332 |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Genetic Nutrition Social and psychosocial factors |
| Keywords | lymphoma, Health episodes, incidence, mortality |
| Scientific investigator(s) (Contact) | |
| Name of the director | Beaugerie |
| Surname | Laurent |
| laurent.beaugerie@sat.aphp.fr | |
| Unit | UMRS-S 707 |
| Organization | INSERM - Institut National de Santé et Recherche |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | PHRC, LIGUE CONTRE LE CANCER AFA, SNFGE, FERRING |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM - Institut National de Santé et Recherche Médicale |
| 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 |
No |
| Additional information regarding sample selection. | Inclusion method: Prospective Other bodies active in creating this cohort: URC, AFA, ANGH, CREGG, FFCD, GETAID, GFHGNP, SFED, SNCP, SNFGE, TLA REVUE FRANCOPHONE DE GASTRO-ENTEROLOGIE, PHARMACEUTICAL COMPANIES INVOLVED IN THE TREATMENT OF IBD, L'ASSOCIATION FRANÇAISE DES MALADES ATTEINTS DE MICI, REGIONAL FMC GASTROENTEROLOGY ASSOCIATIONS |
| Database objective | |
| Main objective | General objective: To test the hypothesis that the use of immunosuppressants (IS) for inflammatory bowel disease (IBD) leads to an increased risk of lymphoma in a cohort population. Secondary objective: to assess - relative risk associated with IS treatment for all cancers, to assess the standardised incidence rate for all other cancers observed during IBD; -The increased risk of colorectal cancer associated with extensive and former colonic inflammation for ulcerative colitis (UC) and Crohn's disease: - Increased risk of ileal adenocarcinoma associated with chronic ileal inflammation in Crohn's disease; - Evaluation of mortality of patients with IBD diseases and risk factors; - Protective role of salicylates, pregnancy and malformation syndromes. |
| Inclusion criteria | Subjects with IBD (Crohn's disease, ulcerative colitis, and indeterminate colitis) defined according to the usual diagnostic criteria, who attended consultation at least once between May 2005 and May 2006. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Multicentric cohort throughout France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 05/2006 |
| Date of last collection (YYYY or MM/YYYY) | 12/2007 |
| Size of the database | |
| Size of the database (number of individuals) |
Greater than 20 000 individuals |
| Details of the number of individuals | 20819 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Biological data (detail) | Type of samples taken: tumour tissues for cancer cases |
| Presence of a biobank |
Yes |
| Contents of biobank |
Tissues |
| Details of biobank content | CANCER TISSUE BANK: LYMPH NODE SAMPLES FOR LYMPHOMA CASES, COLON CANCER |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 29 months |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CépiDc |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/CESAME |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=%28cesame+AND+Beaugerie[Author]%29+OR+22157331[uid] |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Data may be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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