CEREVANCE - National Prospective Cohort Follow-Up for Children with Severe Autoimmune Cytopenia

Head :
Perel Yves, UNITÉ D'HEMATO-ONCOLOGIE PÉDIATRIQUE
Aladjidi Nathalie, UNITÉ D'HEMATO-ONCOLOGIE PÉDIATRIQUE - CEREVANCE

Last update : 07/08/2014 | Version : 1 | ID : 60196

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
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 National Prospective Cohort Follow-Up for Children with Severe Autoimmune Cytopenia
Sign or acronym CEREVANCE
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation Accord CNIL: 17/11/2004
General Aspects
Medical area Cardiology
Immunology
Rare diseases
Health determinants Genetic
Others (details) Autoimmune cytopenia, autoimmune haemolytic anaemia, Evans syndrome, chronic immune thrombocytopenic purpura
Keywords Clinical progression, prognostic factors, autoimmune haemolytic anaemia, Evans syndrome, chronic immune thrombocytopenic purpura, research network, biobank, physiopathological mechanisms of these diseases, child
Scientific investigator(s) (Contact)
Name of the director Perel
Surname Yves
Address 33076 BORDEAUX
Phone +33 (0)5 57 82 02 61
Email yves.perel@chu-bordeaux.fr
Unit UNITÉ D'HEMATO-ONCOLOGIE PÉDIATRIQUE
Organization CHU
Name of the director Aladjidi
Surname Nathalie
Address 33076 BORDEAUX
Phone +33 (0)5 57 82 04 40
Email nathalie.aladjidi@chu-bordeaux.fr
Unit UNITÉ D'HEMATO-ONCOLOGIE PÉDIATRIQUE - CEREVANCE
Organization CHU
Collaborations
Funding
Funding status Public
Details Institut des Maladies Rares (2004), Ministère de la santé (PHRC 2005), Centre de Référence Maladies Rares (2007)
Governance of the database
Sponsor(s) or organisation(s) responsible CHU Bordeaux
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: 01/06/2011
Database objective
Main objective General objective: To prospectively study clinical and paraclinical evolution as well as prognostic factors for autoimmune haemolytic anaemia, Evans syndrome and chronic immune thrombocytopenic purpura among children in France - To generate support for a basic and therapeutic research network for these diseases Secondary objectives - To develop a biobank to study the physiopathological mechanisms of these diseases - To generate support for a national network for epidemiological, clinical, biological and therapeutic research for these diseases
Inclusion criteria Under 18 years of age and affiliated with a social security scheme - Living in mainland France Patients with AIHA, chronic ITP and/or ES, regardless of underlying factors Free informed written and signed consent by parental authority holders as well as the child or adolescent if they are of age Exclusion criteria: constitutional haemolytic anaemia and constitutional platelet disease
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 National
Detail of the geography area Multicentric cohort throughout France (30 centres)
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 06/2008
Date of last collection (YYYY or MM/YYYY) 06/2011
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 265
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Biological data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Biological data (detail) FBC, reticulocytes, blood group, rhesus, haemolysis markers (haptoglobin, LDH, total and unconjugated bilirubin), renal function, liver function test, Coombs test, MAIPA, immunoglobulin quantitation, lymphocyte phenotyping, autoantibody markers (FAN, anti-DNA, anti-phospholipid, thyroid ...), other examinations according to clinical context
Presence of a biobank Yes
Contents of biobank Whole blood
Serum
Plasma
DNA
Details of biobank content Serum bank, Plasma bank, DNA bank
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Data collection method Clinical examinations: manual input with double data entry Biological analysis: manual input with double data entry
Participant monitoring Yes
Details on monitoring of participants Minimum follow-up every 6 months for 3 years, then annual
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term
Access
Terms of data access (charter for data provision, format of data, availability delay) To be decided if data may be used by academic teams To be decided if data may be used by industrial teams
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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