ITMO public health
Last update : 07/22/2015 | Version : 2 | ID : 6711
| General | |
| Identification | |
| Detailed name | Assessment and Follow-Up of Early Undifferentiated Rheumatoid Arthritis |
| Sign or acronym | ESPOIR |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: 902156 (02-1387); Afssaps: DGS 2002/0541; n°CPP: 02 03 07 (12/07/2002) |
| General Aspects | |
| Medical area |
Rheumatology |
| Health determinants |
Addictions Genetic Occupation Social and psychosocial factors |
| Keywords | rheumatoid arthritis, Cohort |
| Scientific investigator(s) (Contact) | |
| Name of the director | Combe |
| Surname | Bernard |
| Address | 371 avenue du Doyen Gaston Giraud 34090 Montpellier |
| Phone | +33 (0)4 67 33 87 10 |
| b-combe@chu-montpellier.fr | |
| Organization | Société Française de Rhumatologie |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Société Française de Rhumatologie - Institut National de la Santé et de la Recherche Médicale- Laboratoire MSD- Laboratoire Pfizer- Laboratoire Abbvie- Laboratoire Roche Chugai |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Société Française de Rhumatologie |
| 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. | Multi-centric from pre-inclusion criteria. |
| Database objective | |
| Main objective | To form a multicentric French cohort for early arthritis (less than 6 months duration) in order to establish a database for diagnostic, prognostic, medico-economic and pathogenetic studies. |
| Inclusion criteria | - Men or women - between 18 and 70 years old - affiliated with a social security scheme - who have at least 2 forms of arthritis for less than 6 weeks/months - who have not received any corticosteroids within the last 6 months (except for treatments lasting less than 2 weeks and infiltration if over 4 weeks before inclusion; except for oral steroid therapy over a period less than 2 weeks, averaging less than 20mg/day, concluded at least 15 days prior to inclusion) |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France CHU Nord (Amiens), CHU Pellegrin Tripode (Bordeaux), CHU La Cavale Blanche (Brest), CHU R.Salengro (Lille), CHU Lapeyronie (Montpellier), CHU St Antoine (Paris), CHU Avicenne (Paris), CHU La Pitié Salpétrière (Paris), CHU Cochin (Paris), CHU Bicêtre (Paris), CHU Bichat-Lariboisière (Paris), CHU Bois Guillaume (Rouen), CHU Hautepierre (Strasbourg), CHU Trousseau (Tours) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 10/2002 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 813 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview Phone interview |
| Paraclinical data (detail) | - frontal hand and wrist x-rays, frontal and three quarter feet x-rays - feet and hand ultrasounds - hand and feet MRI (only in certain centres) |
| Biological data (detail) | DNA (tissue and synovial fluid), serums, usual biological samples: blood count, platelets, erythrocyte sedimentation rate, C-reactive protein, aspartate aminotransferase, alanine aminotransferase, gamma GT (baseline), glucose, rheumatoid factor, anti-cyclic citrullinated peptide, antinuclear antibodies (baseline), anti-native DNA (baseline), human leukocyte antigens (baseline) alkaline phosphatase (baseline), creatine (baseline) |
| Administrative data (detail) | Gender, date of birth, place of birth, ethnic origin, level of education |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Fluids (saliva, urine, amniotic fluid, …) Tissues DNA |
| Details of biobank content | Serum bank, other fluids, tissue, DNA bank |
| Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Data gathered by CRF and recorded on Access database. Data sent weekly to coordinating centre. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Total follow-up duration: 10 years (current request for 10 additional years for a total duration of 20 years in progress). Follow-up every 6 months for 2 years and then becoming annual. Self-administered questionnaire, medical examination and normal biological samples are carried out at each visit. X-rays are carried out at baseline, 6 months, 12 months, 18 months, 2 years, 3 years, 5 years and 10 years. Biobank (serum) is carried out at baseline, 6 months, 12 months, 18 months, 2 years, 3 years, 5 years and 10 years. Urine is collected at baseline until 2 years. An overview of patients who were not followed-up (lost to follow-up, refusal) is carried out twice a year. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://sfr.larhumatologie.fr/rc/rhumatologie/htm/Article/2010/59d645a5cc26d0e80d4052f3ca0a70ab/src/htm_fullText/fr/Combe%20ESPOIR%20bonsoi_JBS%20271911.pdf |
| Link to the document | http://sfr.larhumatologie.fr/rc/rhumatologie/htm/Article/2010/59d645a5cc26d0e80d4052f3ca0a70ab/src/htm_fullText/fr/Fautrel%20Rheumatology%202009%2009-0579.pdf |
| Link to the document | http://sfr.larhumatologie.fr/rc/rhumatologie/htm/Article/2010/59d645a5cc26d0e80d4052f3ca0a70ab/src/htm_fullText/fr/090201-Echo%20ESPOIR.pdf |
| Link to the document | http://sfr.larhumatologie.fr/rc/rhumatologie/htm/Article/2010/59d645a5cc26d0e80d4052f3ca0a70ab/src/htm_fullText/fr/Lukas%20ESPOIR%20ClinExpRheum%202009.pdf |
| Link to the document | http://sfr.larhumatologie.fr/rc/rhumatologie/htm/Article/2010/59d645a5cc26d0e80d4052f3ca0a70ab/src/htm_fullText/fr/Benhamou%20J%20rheumatol%20JR%202009.pdf |
| Link to the document | http://sfr.larhumatologie.fr/rc/rhumatologie/htm/Article/2010/59d645a5cc26d0e80d4052f3ca0a70ab/src/htm_fullText/fr/Guennoc-JRheumatol%20june%2009.pdf |
| Link to the document | http://tinyurl.com/HAL-ESPOIR |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=espoir+AND+arthritis |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Project data following call for proposals (twice per year) addressed to the Chairman of the Scientific Council and reviewed by two specialists. Final approval is given by the Scientific Council. Specific data are transferred after signing an agreement. A list of publications and works is available on the website. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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