NEPHROVIR 2 - CHILDHOOD NEPHROTIC SYNDROME (2)
Head :
Deschenes Georges, INSERM UMR699
Last update : 06/30/2014 | Version : 1 | ID : 5128
| General | |
| Identification | |
| Detailed name | CHILDHOOD NEPHROTIC SYNDROME (2) |
| Sign or acronym | NEPHROVIR 2 |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL |
| General Aspects | |
| Medical area |
Urology, andrology and nephrology |
| Others (details) | Nephrotic syndrome |
| Keywords | Analysis, immuno-virological status, idiopathic, corticosteroids, B lymphocytes, health episodes, proteinuria, glucocorticoids, after-effect, immunosuppressants, Epstein Barr Virus (EBV), impact, progression, incidence, recurrence, complications |
| Scientific investigator(s) (Contact) | |
| Name of the director | Deschenes |
| Surname | Georges |
| Address | Faculté de Médecine Xavier Bichat, 16 rue Henri Huchard, 75018 Paris |
| Phone | + 33 (0)1 40 03 21 42 |
| georges.deschenes@rdb.aphp.fr | |
| Unit | INSERM UMR699 |
| Organization | INSERM - |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Direction générale de la santé DGS- Le programme hospitalier de recherche clinique PHRC (nephrovir-2) DHOS |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | AP-HP |
| Organisation status |
Public |
| 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. | Inclusion method: Prospective Other bodies active in creating this cohort: CHU, CHG |
| Database objective | |
| Main objective | To analyse the immuno-virological status of patients concerning Epstein Barr Virus (EBV) during the first manifestation of idiopathic nephrotic syndrome, and its impact on steroid therapy progression. A further study is proposed for the phenotypic characterisation and analysis of B lymphocytes in patients with relation to the EBV cycle. |
| Inclusion criteria | Children between 6 months and 15 years old, living in the Ile de France area, with first manifestation of idiopathic nephrotic syndrome defined as proteinuria higher than 50 mg/kg/day or proteinuria/creatinine higher than 0.25 g/mmol and hypoalbuminemia less than 30 g/L. Group 2: negative serology for hepatitis B and hepatitis C virus, no decrease in C3 component. Group 3: samples for hepatitis B virus, hepatitis C virus and C3 complement component serology. Children not living in Ile de France at time of first manifestation are excluded. |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Ile de France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 12/2007 |
| Date of last collection (YYYY or MM/YYYY) | 06/2020 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 350 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Medical registration |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Plasma DNA |
| Details of biobank content | Plasma bank, DNA bank, cell bank |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Blood samples (2.5 mL EDTA and 2 tubes of 2.4 mL ACD) collected for study during routine laboratory tests are sent to the Clinical Investigation Centre (CIC) at the Hôpital Robert Debré: The EDTA tube will be immediately forwarded to the pharmacology laboratory for plasma collection and DNA extraction before aliquoting and freezing with further genetic study. Self-administered questionnaire: From paper questionnaire (Manual input) |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 10 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by industrial teams. Contractual access. Data may not be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
