ITMO public health
Last update : 07/09/2015 | Version : 2 | ID : 60132
| General | |
| Identification | |
| Detailed name | NephroTest |
| Sign or acronym | NEPHROTEST |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP 09298, CNIL DR 2010-149 |
| General Aspects | |
| Medical area |
Urology, andrology and nephrology |
| Keywords | renal function, glomerular filtration rate, vascular and metabolic complications, renal replacement therapy, Health episodes, quality of life, mortality |
| Scientific investigator(s) (Contact) | |
| Name of the director | Stengel |
| Surname | Bénédicte |
| Address | 94807 VILLEJUIF CEDEX |
| Phone | + 33 (0)1 45 59 50 39 |
| benedicte.stengel@inserm.fr | |
| Unit | INSERM U1018 CENTRE DE RECHERCHE EN ÉPIDÉMIOLOGIE ET SANTÉ DES POPULATIONS |
| Organization | INSERM |
| Name of the director | Froissart |
| Address | 75006 PARIS |
| Phone | + 33 (0)1 56 09 39 73 |
| marc.froissart@parisdescartes.fr | |
| Unit | UMR 872 EQ.3 |
| Organization | INSERM |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Ministère de la recherche, INSERM, Agence de Biomédecine, Laboratoires Roche, AMGEN |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM |
| 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. | Prospective Inclusion cut-off date not determined |
| Database objective | |
| Main objective | General objective: To identify new biomarkers along with environmental and genetic risk factors for chronic kidney disease progression and related complications Secondary objectives: - To describe the natural history of chronic kidney disease in terms of optimised treatment according to international recommendations - To evaluate the realisation and relevance of the recommended objectives (K/DOQI, KDIGO, HAS) |
| Inclusion criteria | Patients over 18 years of age with chronic kidney disease confirmed by the presence of kidney damage markers: biological, morphological or histological abnormalities and glomerular filtration rate measurement by reference method (renal clearance of 51CR-EDTA), stages 1-5 of the 2005 KDIGO classification, not on dialysis and not grafted. |
| 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 |
Local |
| French regions covered by the database |
Aquitaine Limousin Poitou-Charentes Île-de-France |
| Detail of the geography area | Multicentric cohort (3 centres) throughout France (Ile de France and Bordeaux) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2001 |
| Date of last collection (YYYY or MM/YYYY) | 12/2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1835 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Paraclinical data (detail) | Imaging (pulse wave velocity, bioimpedance) |
| Biological data (detail) | Type of samples taken: blood and urine |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma Fluids (saliva, urine, amniotic fluid, …) DNA |
| Details of biobank content | Serum bank, plasma bank, DNA bank, urine bank in progress |
| Health parameters studied |
Health event/morbidity Health event/mortality Quality of life/health perception |
| Procedures | |
| Data collection method | Self-administered questionnaire: input from a paper questionnaire (manual input) Interview: input from a paper questionnaire (manual input) Clinical examinations handwritten (manual input) Biological analysis: direct input (Other) Other collection for biological analysis: direct import from laboratory data management system (interfaces) |
| Participant monitoring |
Yes |
| Details on monitoring of participants | (Indefinite duration) |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | Pathology register |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/NEPHROTEST |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-NEPHROTEST |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Data may be used by industrial teams via the industrial steering committee |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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