- Case-Control Study on the Relation Between Systemic Sclerosis and Occupational Exposure 
Head :
Marie Isabelle, INSERM U 905
Last update : 01/01/2018 | Version : 1 | ID : 73181
| General | |
| Identification | |
| Detailed name | Case-Control Study on the Relation Between Systemic Sclerosis and Occupational Exposure |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Approval: CPP Upper Normandy |
| General Aspects | |
| Medical area |
Immunology |
| Pathology (details) | Systemic sclerosis |
| Health determinants |
Lifestyle and behavior Occupation Pollution |
| Keywords | crystalline silica, keytones, occupational exposure, solvents, scleroderma, smoking, tobacco |
| Scientific investigator(s) (Contact) | |
| Name of the director | Marie |
| Surname | Isabelle |
| isabelle.marie@chu-rouen.fr | |
| Unit | INSERM U 905 |
| Organization | Rouen University Hospital |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Ministry of Health, Rouen University Hospital, Pfizer Pharmaceutical Laboratory |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Rouen University Hospital |
| 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 |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Matching case-control by gender, age and smoking habits. |
| Database objective | |
| Main objective | The aim of the study is to investigate the relation between systemic sclerosis and occupational exposure, and to define the risk of systemic sclerosis in male and female patients that is linked to occupational exposure. |
| Inclusion criteria |
Patients with systemic sclerosis (declared) consulting at one of 3 participating centres (Departments of Internal Medicine, Dermatology and Pneumology in Rouen, Elbeuf and Le Havre) between 2005 and 2008.
Controls: Subjects with a chronic illness or an acute illness who do not have: a connective tissue disorder; systemic vasculitis and other systemic autoimmune disorders; neoplasia and chronic interstitial lung disease. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Normandie |
| Detail of the geography area | Upper Normandy |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2005 |
| Date of last collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 100 cases/300 controls |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | 1) Socioeconomic characteristics; 2) smoking habits; 3) prior use of drugs already implicated in the development of scleroderma e.g. anorexigens, pentazocine, bromocriptine, taxanes and L-tryptophan; 4) history of: prosthesis (e.g. hip, knee); contact lenses, cosmetic surgery (parrafin, processed petroleum jelly, silicone implants) and hair dye, as well as 5) occupational history. Exposure to crystalline silica, white spirits, solvents (chlorinated solvents, trichlorethylene, toluene, xylenes, ketones aromatic solvents, all types), welding fumes, epoxy resins; pesticides and vinyl chloride. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Data is collected by an investigator and for expert committee submissions. |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/24129037 |
| 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 |
