ITMO public health
Last update : 10/22/2015 | Version : 3 | ID : 21204
| General | |
| Identification | |
| Detailed name | Données Informatisées et VAlidées en Transplantation |
| Sign or acronym | DIVAT |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL (17/09/2004) n°891735, Network DIVAT : 10.16.618 |
| General Aspects | |
| Medical area |
Urology, andrology and nephrology |
| Keywords | Transplantation |
| Scientific investigator(s) (Contact) | |
| Name of the director | Giral |
| Surname | Magali |
| Address | 30, bd Jean Monnet, 44093 Nantes Cedex 01 |
| Phone | +33(0)2.40.08.74.43 |
| mgiral@chu-nantes.fr | |
| Unit | Institut de Transplantation Urologie Néphrologie, RTRS “Centaure”, UMR Inserm 1064Centre d'Investigation Clinique et de Biothérapie |
| Organization | Centre Hospitalier Universitaire Hôtel Dieu |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Each center supports its own costs of creation, follow-up and development.We occasionaly receive a financial support from private pharmaceutical lab. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut de Transplantation Urologie Néphrologie, RTRS “Centaure”, UMR Inserm 1064 |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Morbidity registers |
| Additional information regarding sample selection. | All recipients of a kidney and/or a pancreas transplant are included in the cohort. |
| Database objective | |
| Main objective | The eight centers established between them collaboration in order to be able to collect and exchange information, to conduct clinical and epidemiological studies all together, to communicate and exchange data and results with other academic researchers, to construct partnership with pharmaceutical industries and to create a biocollection database linked to clinical data (for 3 of the 8 centers). |
| Inclusion criteria | Kidney and/or pancreas transplant recipients |
| Population type | |
| Age |
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 | Nantes, Nancy, Montpellier, Toulouse, Necker (Paris), Lyon, Saint-Louis (Paris) et Nice |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1994 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 11000 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Paraclinical data (detail) | Biopsies of the transplant at pre- or post-transplantation. Identification of bacterial, viral, parasitic or mycotic infectious agents. |
| Biological data (detail) | At pre-transplantation : viral status, immunization and only for pancreas transplantations (C-peptide, HbA1C, serum creatinin, serum proteins, serum albumin, LDL, HDL, cholesterol, triglycerides). At post-transplantation : serum creatinin, proteinuria, hemoglobin, LDL, triglycerides, immunization and only for pancreas transplantations (glycemia, C-peptide, HbA1C, insuline, serum amylase, serum lipase, cholesterol). |
| Administrative data (detail) | File number, Cristal number (registration on waiting list), patient contact details and name of referring doctor. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma Blood cells isolated Fluids (saliva, urine, amniotic fluid, …) |
| Details of biobank content | DMSO CELLS, SERUM, WHOLE BLOOD, TRIZOL CELLS, URINE, PAXGENE, PLASMA |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Data are collected at pre-transplantation and prospectively at each folow-up visit. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up parameters are collected at 3 months, 6 months, 1 year and then every year. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/PUBMED-DIVAT |
| Description | Liste des publications dans Pubmed |
| Link to the document | http://tinyurl.com/HAL-DIVAT |
| Description | Liste des publications dans HAL |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | The Divat network encourage collaborations and enables interested researchers to submit a research project. Guidelines for requesting data analyses from the registry will be soon available on the DIVAT website. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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