DESIR - Development of Early Undifferentiated Spondyloarthritis
Head :
Dougados Maxime, SERVICE DE RHUMATOLOGIE DU PR DOUGADOS HÔPITAL COCHIN
Last update : 07/22/2015 | Version : 2 | ID : 60152
| General | |
| Identification | |
| Detailed name | Development of Early Undifferentiated Spondyloarthritis |
| Sign or acronym | DESIR |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 03/07/2008 |
| General Aspects | |
| Medical area |
Rheumatology |
| Health determinants |
Climate Genetic Geography Pollution |
| Keywords | Natural history, predictive factors, development, progressive factors, genetic factors, ethnic and environmental factors, human impact, economic |
| Scientific investigator(s) (Contact) | |
| Name of the director | Dougados |
| Surname | Maxime |
| Address | 75014 PARIS |
| Phone | + 33 (0)1 58 41 25 62 |
| maxime.dougados@cch.aphp.fr | |
| Unit | SERVICE DE RHUMATOLOGIE DU PR DOUGADOS HÔPITAL COCHIN |
| Organization | HÔPITAL |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Pfizer-Wyeth, Société Française de Rhumatologie, Inserm |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | APHP |
| 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 carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective Inclusion cut-off date: April 2010 |
| Database objective | |
| Main objective | 1) To study the natural history of early inflammatory back pain 2) To identify predictive factors for the development of spondyloarthritis and progressive factors of the disease, including genetic, ethnic and environmental factors 3) To study the human and economic impact of patients with early inflammatory back pain. |
| Inclusion criteria | Men or women over 18 and under 50 years old, presenting early inflammatory back pain defined by: - pain in the buttock, lumbar or thoracic spine region; - fulfilling either the Calin or Berlin criteria or both; - symptom duration more than 3 months and less than 3 years. Symptoms suggestive of spondyloarthritis according to physician's assessment (score greater or equal to 5 on a 0 to 10 rating scale). Realisation of a prior medical examination. Informed consent dated and signed voluntarily. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Multicentric cohort throughout France (25 centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 12/2007 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 708 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Imaging |
| Biological data (detail) | Type of samples taken: serum, urine, DNA, RNA |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | Self-administered questionnaire: double data entry from a paper questionnaire Interview: direct input Clinical Examinations: handwritten with double data entry Biological analysis: handwritten with double data entry |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 10 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/HAL-DESIR |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=desir+AND+Spondyloarthritis |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Researchers from any country can submit a research project to the Cohort Scientific Committee. If the project is approved, cohort data will be made available whether it is the clinical database or biological material and/or imaging equipment. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
