ITMO public health
Last update : 09/05/2017 | Version : 2 | ID : 6062
| General | |
| Identification | |
| Detailed name | Study on long-term iatrogenic effects for women treated for breast cancer between 1954 and 1985 at the Institut Gustave Roussy |
| Sign or acronym | SurvSein |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | -- |
| General Aspects | |
| Medical area |
Cancer research |
| Keywords | Breast cancer, iatrogenic effects, chemotherapy, radiotherapy, dosimetry, second cancer |
| Scientific investigator(s) (Contact) | |
| Name of the director | De Vathaire |
| Surname | Florent |
| Address | 114, rue Edouard Vaillant - 94805 Villejuif Cedex |
| Phone | + 33 (0)1 42 11 54 57 |
| florent.devathaire@igr.fr | |
| Unit | U1018 CESP équipe 3 |
| Organization | Institut National de Santé et Recherche |
| Name of the director | Rubino |
| Surname | Carole |
| Address | 114, rue Edouard Vaillant - 94805 Villejuif Cedex |
| Phone | + 33 (0)1 42 11 62 33 |
| carole.rubino@igr.fr | |
| Unit | U1018 CESP équipe 3 |
| Organization | Institut National de Santé et Recherche |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | Association pour la Recherche sur le CancerFondation de France INSERMEDF, FDF |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | 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 is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | The test sample comprises individuals treated for breast cancer between 1954 and 1983. he affected individuals are selected according to whether they develop a second malignant tumour one year after cancer diagnosis. Inclusion method: Retrospective |
| Database objective | |
| Main objective | SurvSein is a prospective and retrospective cohort study of women treated for breast cancer between 1954 and 1983 at the Institut Gustave Roussy in order to measure the iatrogenic effects of long-term treatment. |
| Inclusion criteria | Subjects of female gender Women aged 18 or over Women treated for breast cancer |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Woman |
| Geography area |
Local |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Breast cancer treatment at the Institut Gustave Roussy cancer centre (Villejuif) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1954 |
| Date of last collection (YYYY or MM/YYYY) | 1985 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 7711 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Face to face interview |
| Paraclinical data (detail) | Estimate of ionising radiation dosage received during radiotherapy |
| Biological data (detail) | Clinical and anatomopathological aspects of breast cancer (TNM classification,...) Type of initial treatment (chemotherapy, radiotherapy, hormonal therapy, surgery) |
| Administrative data (detail) | Identification data Vital status and cause of death |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Participant monitoring |
Yes |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | Mortality and vital status data from CépiDc and INSEE respectively |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-Cohorte-SURVSEIN |
| 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 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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