ITMO public health
Last update : 07/29/2015 | Version : 3 | ID : 60197
| General | |
| Identification | |
| Detailed name | Cohort of 5,000 Patients at Risk of Melanoma |
| Sign or acronym | COPARIME 5000 |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 11/04/2011 |
| General Aspects | |
| Medical area |
Cancer research General practice |
| Keywords | malignancies, immune deficiencies, autoimmune diseases, users, Health episodes, prevention, health system |
| Scientific investigator(s) (Contact) | |
| Name of the director | NGuyen |
| Surname | Jean-Michel |
| Address | 44093 NANTES |
| Phone | +33 (0)2 40 84 69 35 |
| Jean-Michel.Nguyen@univ-nantes.fr | |
| Unit | SERVICE D'EPIDÉMIOLOGIE ET DE BIOSTATISTIQUES- CHU NANTES UMR892 ET CHU DE NANTES |
| Organization | CHU |
| Name of the director | Dreno |
| Address | 44093 NANTES |
| Phone | + 33 (0)2 40 08 31 37 |
| Bdreno@wanadoo.fr | |
| Unit | UNITE ONCODERMATOLOGIE-CHU NANTES-UMR892 CHU NANTES |
| Organization | CHU |
| Name of the director | Quereux |
| Surname | Gaëlle |
| Address | 44093 NANTES |
| Phone | + 33 (0)2 40 08 31 44 |
| gaelle.quereux@chu-nantes.fr | |
| Unit | UNITÉ ONCODERMATOLOGIE- UMR892 UNITÉ ONCODERMATOLOGIE- UMR892 |
| Organization | CHU |
| Name of the director | Rat |
| Surname | Cédric |
| Address | 44000 NANTES |
| Phone | + 33 (0)6 61 86 79 53 |
| cedric.rat@univ-nantes.fr | |
| Unit | DÉPARTEMENT DE MÉDECINE GÉNÉRAL |
| Organization | UNIVERSITE DE |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Public |
| Details | INCA |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Nantes |
| 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. | Prospective Inclusion cut-off date: 01/07/2011 |
| Database objective | |
| Main objective | General objective: to estimate the risk of developing de novo melanoma for at-risk patients according to the SAMScore (Self Administrated Melanoma risk score). Secondary objective: - To describe patient epidemiological and clinical characteristics - To develop a biobank in order to facilitate studies on these diseases and to investigate the physiopathogenic, haemato-immunological and genetic mechanisms of the same. - To establish and validate national treatment guidelines according to potential patient sub-groups. |
| Inclusion criteria | Patients having 18 years old or more and at elevated risk of melanoma. |
| 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 |
Departmental |
| French regions covered by the database |
Pays de la Loire |
| Detail of the geography area | Departments of Loire Atlantique and Vendée |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 04/2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 8000 |
| 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: input from a paper questionnaire Clinical examinations: direct input Biological analysis: handwritten |
| Participant monitoring |
Yes |
| Details on monitoring of participants | (Indefinite duration) |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CRAM, other health insurance databases, pathology register |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.em-consulte.com/article/743618/article/cohorte-de-patients-a-risque-de-melanome-coparime- |
| Link to the document | http://www.cclinouest.com/JOSE/Page_2011/nguyen_jose_2011.pdf |
| Link to the document | http://tinyurl.com/Pubmed-COPARIME |
| 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. Contractual access conditions: project submission to the scientific council To be decided if 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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