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
Aladjidi Nathalie, UNITÉ D'HEMATO-ONCOLOGIE PÉDIATRIQUE - CEREVANCE
Last update : 07/08/2014 | Version : 1 | ID : 60196
| 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 |
| 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 |
| 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 |
