NEPHROTEST - NephroTest

Head :
Stengel Bénédicte, INSERM U1018 CENTRE DE RECHERCHE EN ÉPIDÉMIOLOGIE ET SANTÉ DES POPULATIONS
Froissart , UMR 872 EQ.3

Last update : 07/09/2015 | Version : 2 | ID : 60132

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Métadonnées
Identification
General Aspects
Collaborations
Funding
Governance of the database
Scientific investigator(s) (Contact)
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
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
Scientific investigator(s) (Contact)
Name of the director Stengel
Surname Bénédicte
Address 94807 VILLEJUIF CEDEX
Phone + 33 (0)1 45 59 50 39
Email 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
Email marc.froissart@parisdescartes.fr
Unit UMR 872 EQ.3
Organization INSERM
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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