ORLY-EST - Influence the orientation of the lymphocyte response to the occurrence of atherosclerotic complications after renal transplantation
Head :
Ducloux Didier, Service de Néphrologie - UMR1098
Saas Philippe, UMR1098
Saas Philippe, UMR1098
Last update : 07/08/2015 | Version : 2 | ID : 5146
| General | |
| Identification | |
| Detailed name | Influence the orientation of the lymphocyte response to the occurrence of atherosclerotic complications after renal transplantation |
| Sign or acronym | ORLY-EST |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Comité d'éthique (21/06/2006), CCTIRS : N°06.132bis (18/12/2008), CNIL : n°909059 (18/05/2009), collection biologique : DC-2008-713 (11/06/2009) |
| General Aspects | |
| Medical area |
Hematology Urology, andrology and nephrology |
| Health determinants |
Iatrogenic |
| Keywords | Immunological mechanisms, immune monitoring, renal transplant patients, transplantation, cohort |
| Scientific investigator(s) (Contact) | |
| Name of the director | Ducloux |
| Surname | Didier |
| Address | 2, place Saint-Jacques 25030 Besançon cedex |
| Phone | +33 (0)3.81.66.87.05 |
| dducloux@chu-besancon.fr | |
| Unit | Service de Néphrologie - UMR1098 |
| Organization | CHRU |
| Name of the director | Saas |
| Surname | Philippe |
| Address | EFS BFC - 1, Bd A. Fleming 25020 Besançon cedex |
| Phone | + 33 (0)3 81 61 56 15 |
| Unit | UMR1098 |
| Organization | EFS |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Le programme hospitalier de recherche clinique PHRC régionalFinancement DHOS-INSERM (L’Institut National de la Santé et de la Recherche Médicale et la Direction de l’Hospitalisation et de l’Organisation des Soins)Le programme hospitalier de recherche clinique PHRC interrégional |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHRU Besançon |
| 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 is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Studying in detail the immunological mechanisms of atherosclerosis after transplantation via immunomonitoring cohort of renal transplant patients |
| Inclusion criteria | Major renal transplant patients |
| 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 |
Regional |
| French regions covered by the database |
Alsace Champagne-Ardenne Lorraine Auvergne Rhône-Alpes Bourgogne Franche-Comté Île-de-France |
| Detail of the geography area | Inter-région Grand Est (Besançon, Strasbourg, Reims, Nancy et plus récemment Dijon, Le Kremlin-Bicêtre et Clermont-Ferrand) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 04/2009 |
| Date of last collection (YYYY or MM/YYYY) | 09/2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 604 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Biological data (detail) | Blood volume collected (42 ml at 0 and 40 ml at one year and three years after transplantation) |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Blood cells isolated |
| Details of biobank content | Serum and cells for molecular and cellular analyzes |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Data are collected on the CRFs as and when they are obtained |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Included patients were followed 1, 3, 5 and 10 years after renal transplantation. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=Orly-Est+OR+25758660[uid]+OR+24511120[uid] |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
