Last update : 08/18/2015 | Version : 3 | ID : 60127
| General | |
| Identification | |
| Detailed name | Post-Occupational Surveillance of Exposed Workers |
| Sign or acronym | SPIRALE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: 27/05/2005 |
| General Aspects | |
| Medical area |
Cancer research Occupational Medicine |
| Health determinants |
Occupation |
| Keywords | health events, mortality, prevention, environment, healthcare system |
| Scientific investigator(s) (Contact) | |
| Name of the director | Carton |
| Surname | Matthieu |
| Address | 94800 VILLEJUIF |
| Phone | + 33 (0)1 77 74 74 29 |
| matthieu.carton@inserm.fr | |
| Unit | INSERM U687 MIXTE : INSERM ET CNAMTS |
| Organization | INSERM - Institut National de Santé et Recherche |
| Name of the director | Zins |
| Surname | Marie |
| Address | 94800 VILLEJUIF |
| Phone | + 33 (0)1 77 74 74 28 |
| marie.zins@inserm.fr | |
| Unit | INSERM U687 MIXTE : INSERM, CNAMTS |
| Organization | INSERM - Institut National de Santé et Recherche |
| Name of the director | Goldberg |
| Surname | Marcel |
| Address | 94800 VILLEJUIF |
| Phone | + 33 (0)1 77 74 74 26 |
| marcel.goldberg@inserm.fr | |
| Unit | INSERM U687 INSERM U687 |
| Organization | INSERM - Institut National de Santé et Recherche |
| Collaborations | |
| Others | Other related cohorts: ESPRI (the same as SPIRALE but for RSI [Social Security Scheme for Independent Workers] artisans (under DST-INVS)). |
| Funding | |
| Funding status |
Public |
| Details | CNAMTS, INCA. |
| 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 population file |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at individual level |
| Additional information regarding sample selection. | Prospective. Other bodies active in creating this cohort: HEALTH EXAMINATION CLINICS. |
| Database objective | |
| Main objective |
General objective: to identify retired workers that were exposed to carcinogens throughout their professional life; to inform them of their right to post-occupational medical monitoring and to support them throughout their efforts.
Secondary objective: to conduct an epidemiological (cohort) study to describe the long-term health effects of the considered exposures, and to assess the benefits of post-occupational monitoring in terms of health and social awareness. |
| Inclusion criteria |
Occupational exposure to asbestos or wood dust;
Insured under the general social security scheme. |
| Population type | |
| Age |
Elderly (65 to 79 years) |
| Population covered |
General population |
| Gender |
Male |
| Geography area |
National |
| Detail of the geography area | 13 metropolitan départements in 2008 (France). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 09/2006 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 2,084 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination at baseline. |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Details of collected declarative data | Self-administered questionnaire at baseline. Information collected by self-administered questionnaire: occupations and sectors occupied, previous treatment for exposure to carcinogens. Interview questionnaire at baseline. Information collected during interview: work calendar, assessment of exposure to asbestos and wood dust, smoking and alcohol consumption. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Self-administered questionnaire: recorded from a paper questionnaire (optical input). Interview: recorded from paper questionnaire (optical input). |
| Quality procedure(s) used | Consistency request when entering computer data and after recording computer data. Missing data managed by returning to third party. Other quality procedure(s): analysis of work calenders. Exposure assessments are verified by cross-reference with an occupational exposure matrix. Patients are informed about the use of their data. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Annual for SNIIRAM (including PMSI). Every 10 years for mortality (not currently in progress, planned for 2019). |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | PMSI, SNIIRAM, CépiDc. |
| Promotion and access | |
| Promotion | |
| Link to the document | spirale et espri beh_46_47_2006.pdf |
| Link to the document | beh_41_42_2007.pdf |
| Link to the document | rmr373.pdf |
| Link to the document | 1148_ep5-6_315_art8_full.pdf |
| Link to the document | suivi_post_professionnel.pdf |
| Link to the document | http://tinyurl.com/HAL-SPIRALE |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=%28Carton[author]+OR+Zins[author]+OR+Golberg[author]%29+AND+Spirale |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
To be decided if data may be used by academic teams.
To be decided if 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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