ASSESS - Assessment of Systemic Involvement and Progression for Patients with Primary Sjogren's Syndrome 
Head :
Gottenberg Jacques-Eric, U1109 Immuno-rhumatologie moléculaire
Last update : 01/01/2019 | Version : 2 | ID : 6873
| General | |
| Identification | |
| Detailed name | Assessment of Systemic Involvement and Progression for Patients with Primary Sjogren's Syndrome |
| Sign or acronym | ASSESS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP 26/01/2007 N° 0711468 |
| General Aspects | |
| Medical area |
Immunology |
| Keywords | Prevalence, risk factor |
| Scientific investigator(s) (Contact) | |
| Name of the director | Gottenberg |
| Surname | Jacques-Eric |
| Address | 1 Place de l'Hôpital 67000 STRASBOURG |
| Phone | +33 (0)3 68 85 33 76 |
| jacques-eric.gottenberg@chru-strasbourg.fr | |
| Unit | U1109 Immuno-rhumatologie moléculaire |
| Organization | CHU |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Ministère de la santé (Programme Hospitalier de Recherche Clinique 2005 P060228) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Strasbourg |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| 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 |
| Database objective | |
| Main objective | To prospectively determine for the first time the prevalence and risk factors for systemic complications and lymphoma in primary Sjögren's syndrome. |
| Inclusion criteria | - Men or women - adults - patients in tertiary centres for autoimmune diseases |
| Population type | |
| Age |
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 (15 Centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2006 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 395 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum DNA DNAc/RNAm |
| Details of biobank content | ------------- |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Paper case report form (CRF) completed by the investigator or co-investigator. CRFs are then sent to a data manager for input. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up for serious adverse events. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Hal-ASSESS |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-ASSESS |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data unavailable to other researchers, except for authorisation requests for IP data mining to the coordinating investigator |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
