ITMO public health
Last update : 05/29/2014 | Version : 1 | ID : 60110
| General | |
| Identification | |
| Detailed name | Contraception and recurrent venous event |
| Sign or acronym | COREVE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Health determinants |
Addictions Occupation |
| Others (details) | venous thrombosis |
| Keywords | Evaluation, types of hormonal contraception, recurrence, impact, risk |
| Scientific investigator(s) (Contact) | |
| Name of the director | Scarabin |
| Surname | Pierre-Yves |
| Phone | + 33 (0)1 45 59 51 14 |
| pierre-yves.scarabin@inserm.fr | |
| Unit | INSERM U1018 CENTRE DE RECHERCHE EN ÉPIDÉMIOLOGIE ET SANTÉ DES POPULATIONS |
| Organization | INSERM |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | INSERM, PIERRE FABRE MEDICAMENT |
| 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. | Prospective Other bodies active in creating this cohort: PIERRE-YVES SCARABIN; GENEVIEVE PLU BUREAU; JACQUELINE CONARD; MARIE HELENE HORELLOU. |
| Database objective | |
| Main objective | General objective: to study whether or not different forms of hormonal contraception contribute to the risk of venous thrombosis recurrence for women at high risk of venous thromboembolism. |
| Inclusion criteria | Women aged between 18 and 45 years attending Hôtel-Dieu de Paris Hospital for the first documented instance of a venous thrombotic event (Doppler ultrasound, computed tomography angiography scan, angiogram, etc.) and/or thrombophilia (factor V Leiden, prothrombin 20210a mutation, ATIII deficiency, PC, PS). |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) |
| Population covered |
Sick population |
| Gender |
Woman |
| Geography area |
Local |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Paris and surrounding region |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 2500 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Paraclinical data (detail) | Medical Imaging |
| Biological data (detail) | Type of samples collected: Systematic testing for thrombophilia as part of a specialist consultation. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Self-administered questionnaire: double data entry from paper questionnaire Interview: double data entry from paper questionnaire Clinical Examinations: handwritten with double data entry |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| 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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