ITMO public health
Last update : 07/07/2015 | Version : 2 | ID : 7206
| General | |
| Identification | |
| Detailed name | Genetics nephropathy and sib pair study |
| Sign or acronym | GENESIS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Endocrinology and metabolism Urology, andrology and nephrology |
| Health determinants |
Genetic |
| Keywords | Renal insufficiency, myocardial infarction, diabetes |
| Scientific investigator(s) (Contact) | |
| Name of the director | Marre |
| Surname | Michel |
| michel.marre@bch.aphp.fr | |
| Unit | U695 |
| Organization | Institut National de la Santé et de la Recherche |
| Name of the director | Hadjaj |
| s.hadjadj@chu-poitiers.fr | |
| Unit | U695 |
| Organization | Institut National de la Santé et de la Recherche |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | Programme hospitalier de recherche cliniqueInstitut national de la santé et de la recherche médicaleAssociation ADRV Paris FranceAssociation GEMMS, Poitiers, France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | 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) |
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. | Inclusion mode: prospective. Other organizations actives in the constitution of the cohort: the clinical research technician: Mme C. DEMER, CHU of Poitiers - places: endocrinology services - CHU of Poitiers (maintenance of the database) - INSERM U695: bio-bank localization. End of inclusions : 01/01/2001 |
| Database objective | |
| Main objective |
GENESIS study, aiming to complete the GENEDIAB study (genetics, nephropathy, diabetes) and the angevan mono-centric cohort Surgene, recruited in a transversal way type 1 diabetic patients presenting a diabetic nephropathy or protected against diabetic nephropathy and proposed them to include their related.
The objective of the cohort has been to follow longitudinally the cardiovascular and renal future of type 1 diabetic patients, 4 to 8 years after their inclusion |
| Inclusion criteria | Type 1 diabetes+retinopathy at all stages+diabetic nephropathy or normo-albuminuria and normal kidney function. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | International multi-centric cohort (13 centers), including Belgium and France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/1998 |
| Date of last collection (YYYY or MM/YYYY) | 01/2006 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1064 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination at inclusion and during the follow-up. Information collected during the examination: weight, size, blood pressure, cardiovascular and renal events. If death, date and cause (medical specialist or general practitioner) |
| Biological data (detail) | Samples: serum creatinine, urinary albumin excretion, HBA1C |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma Fluids (saliva, urine, amniotic fluid, …) DNA |
| Details of biobank content | Serum, plasma, DNA, urine bank |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Clinical examinations: hand-written step (manual entry) |
| Quality procedure(s) used | Coherence request during after computer data entry. Follow-up data are considered with the last date as a closure date. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 6 years follow-up |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-GENESIS |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be defined iwth the scientific investigator |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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