COREVE - Contraception and recurrent venous event

Head :
Scarabin Pierre-Yves, INSERM U1018 CENTRE DE RECHERCHE EN ÉPIDÉMIOLOGIE ET SANTÉ DES POPULATIONS

Last update : 05/29/2014 | Version : 1 | ID : 60110

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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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