ITMO public health
Last update : 09/05/2017 | Version : 1 | ID : 5552
| General | |
| Identification | |
| Detailed name | EStrogen THromboEmbolism Risk |
| Sign or acronym | ESTHER |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL 999271, CCPPRB Brest 24 aout 1998, DGS 980433 |
| General Aspects | |
| Medical area |
Cardiology Endocrinology and metabolism |
| Health determinants |
Iatrogenic |
| Others (details) | Menopause hormone therapy |
| Keywords | Menopause, hormone therapy, progesterone, oestrogen, progestin |
| Scientific investigator(s) (Contact) | |
| Name of the director | Scarabin |
| Surname | Pierre-Yves |
| Address | 16 Avenue Paul Vaillant Couturier, 94807 VILLEJUIF |
| Phone | +33 (0)1 45 59 51 12 |
| pierre-yves.scarabin@inserm.fr | |
| Organization | Institut National de la Santé et de la Recherche |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | - Fondation de France - Fondation pour la Recherche Médicale - Institut Nationale de la Santé et de la Recherche Médicale - Besins International - Sanofi |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services A population file |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Hospital and commuinity case subjects, hospital and community case-controls (randomly selected from electoral registers) |
| Database objective | |
| Main objective | To evaluate the risk of venous thromboembolism in connection with hormone therapy for menopause while considering the administration route for oestrogen and types of progestin. |
| Inclusion criteria | - Women - between 45 and 65 years of age - menopausal - with no cardiovascular history or breast cancer |
| Population type | |
| Age |
Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Woman |
| Geography area |
National |
| Detail of the geography area | France (multicentric hospital and general population study) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1999 |
| Date of last collection (YYYY or MM/YYYY) | 2003 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 728 - 195 sujets atteints/cases - 533 témoins/controls |
| 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) |
Face to face interview |
| Presence of a biobank |
Yes |
| Contents of biobank |
DNA |
| Details of biobank content | DNA bank |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Selection and questionnaire by dedicated CRA in each centre |
| Classifications used | ---- |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/12927428 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/15978114 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/16301339 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/16409454 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/16706969 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/17309934 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/18217166 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/18495631 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/18628519 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/19320825 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/19782484 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/21107315 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/12927428 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/16409454 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/16301339 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/17309934 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/18495631 |
| 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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