ITMO public health
Last update : 07/02/2014 | Version : 1 | ID : 5194
| General | |
| Identification | |
| Detailed name | GFRS- 3 GENERATIONS-SCLERODERMA |
| Sign or acronym | 3GENSSC |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | N°de protocole RBM-04-60 (20-09-2004) et collection N°DC-2008-327 (2008) |
| General Aspects | |
| Health determinants |
Genetic |
| Keywords | HLA genotyping, family members, compatibility, microchimerism, autoimmunity markers |
| Scientific investigator(s) (Contact) | |
| Name of the director | Lambert |
| Surname | Nathalie |
| Address | 163 Av. de Luminy –Case 939 Bat TPR2 INSERM Entrée A 1er étage 13288 Marseille Cedex 09 FRANCE |
| Phone | + 33 (0)4 91 82 87 68 |
| nathalie.lambert@inserm.fr | |
| Unit |
Laboratoire d’Immuno-génétique de la polyarthrite UMRs 1097 |
| Organization | INSERM - Institut National de la Santé et de la Recherche |
| Name of the director | Farge |
| Surname | Dominique |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | PRO-A INSERM |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM - Institut National de la Santé et de la Recherche Médicale |
| 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 |
| Additional information regarding sample selection. | New subjects are enrolled from active patient files monitored by recruitment centres |
| Database objective | |
| Main objective | To form the first French cohort of 3 generations of subjects who have scleroderma (SSc). To carry out HLA (human leukocyte antigen) genotyping for all subjects and family members so as to understand the relationship between HLA compatibility between SSc patients with and members of their family and to further study the role of microchimerism and maternal-foetal compatibility. To continue studies previously undertaken on the preponderance of autoimmune disease in women and to research new markers of SSc on a larger number of subjects. |
| Inclusion criteria | Women whose parents are still alive and whose children wish to participate in the study. |
| Population type | |
| Age |
Childhood (6 to 13 years) Adolescence (13 to 18 years) 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 |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 10/2004 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 400 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood |
| Details of biobank content | Whole blood from subjects will be collected in EDTA vacutainer tubes. An aliquot of 350 ul will be retained and DNA will be extracted using a kit (EZ1 DNA Blood Kit, Qiagen, Hilden, Germany) on a BIOROBOT EZ1 according to instructions. |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Family members will be contacted by post by a Clinical Research representative (research engineer). To facilitate geographic difficulties for dispersed families, mouth wash will be sent to collect buccal cells for DNA extraction, or an appointment will be made in accordance with the subject in an analysis laboratory close to the subject's home. |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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