Last update : 09/05/2017 | Version : 2 | ID : 6238
General | |
Identification | |
Detailed name | Study of NorpregnAnes Coagulation |
Sign or acronym | SNAC |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCPPRB Bicêtre (21/12/2005), CNIL (19/12/2005) |
General Aspects | |
Medical area |
Biology Endocrinology and metabolism Internal medicine |
Pathology (details) | Hormone therapy for menopause |
Health determinants |
Medicine |
Keywords | Oestrogen, progestin, menopause, haemostasis, thrombosis |
Scientific investigator(s) (Contact) | |
Collaborations | |
Funding | |
Funding status |
Public |
Details | Institut National de la Santé et de la Recherche Médicale |
Governance of the database | |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
Database recruitment is carried out by an intermediary |
A population file |
Database recruitment is carried out as part of an interventional study |
No |
Additional information regarding sample selection. | Samples selected on a voluntary basis |
Database objective | |
Main objective | Impact of different types of HRT on activated protein C resistance and haemostatic parameters. |
Inclusion criteria | - Women - between 45 and 70 years of age - menopausal |
Population type | |
Age |
Adulthood (45 to 64 years) |
Population covered |
General population |
Gender |
Woman |
Geography area |
Regional |
French regions covered by the database |
Île-de-France |
Detail of the geography area | Centre d'Investigations Préventives et Cliniques de Paris: SS medical examination centre |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 2006 |
Date of last collection (YYYY or MM/YYYY) | 2007 |
Size of the database | |
Size of the database (number of individuals) |
< 500 individuals |
Details of the number of individuals | 300- 100 femmes non traitées/women no treated- 100 femmes estrogènes transdermiques + progestérone- 100 femmes estrogènes transdermiques + NOMAC |
Data | |
Database activity |
Data collection completed |
Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
Clinical data (detail) |
Direct physical measures |
Declarative data (detail) |
Face to face interview |
Paraclinical data (detail) | .... |
Biological data (detail) | - blood - DNA |
Presence of a biobank |
Yes |
Contents of biobank |
Serum Plasma DNA |
Details of biobank content | 500 microL plasma aliquots collected with citrate, heparin or EDTA |
Health parameters studied |
Others |
Other (detail) | .... |
Procedures | |
Data collection method | Standardised questionnaire |
Participant monitoring |
No |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
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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