ITMO public health
Last update : 09/05/2017 | Version : 1 | ID : 5883
| General | |
| Identification | |
| Detailed name | Evaluation of Immunochemical Faecal Occult Blood Tests for Colorectal Cancer Screening |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL |
| General Aspects | |
| Medical area |
Cancer research Immunology |
| Health determinants |
Genetic Nutrition |
| Others (details) | Colorectal cancer |
| Keywords | immunological tests, colonoscopy, occult blood, Screening |
| Scientific investigator(s) (Contact) | |
| Name of the director | Launoy |
| Surname | Guy |
| Address | Avenue Côte de Nacre 14032 Caen Cedex |
| Phone | +33 (0)2 31 06 51 20 |
| launoy@unicaen.fr | |
| Unit | Cancers & Populations |
| Organization | Institut National de Santé et Recherche Médicale, CHU |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | - Caisse Nationale d’Assurance Maladie - Direction générale de la Santé - Ligue contre le Cancer |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de Santé et Recherche Médicale |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | CHU Caen |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at individual level |
| Additional information regarding sample selection. | 164 general practitioners and occupational physicians distributed immunological tests to patients (aged between 50 and 74 years). Tests with a haemoglobin concentration of 20 ng/ml are considered positive. |
| Database objective | |
| Main objective | To demonstrate the use of immunochemical faecal occult blood tests for colorectal cancer screening. |
| Inclusion criteria | - Men or women - aged between 50 and 74 years old |
| Population type | |
| Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
Departmental |
| French regions covered by the database |
Normandie |
| Detail of the geography area | Manche |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2001 |
| Date of last collection (YYYY or MM/YYYY) | 2002 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 7421 - 6987 négatifs/negatives - 434 positifs/positives |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Paraclinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Paraclinical data (detail) | - colonoscopy |
| Biological data (detail) | - immunological test |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 2-year follow-up |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://onlinelibrary.wiley.com/doi/10.1002/ijc.20921/full |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23376426 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22525156 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/21852699 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/21576271 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/20059780 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23376426 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22525156 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/21852699 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/21576271 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/20059780 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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