KIDSEP - Cohort of Children Monitored After First Episode of Acute Demyelination
Head :
Mikaeloff Yann, E109/U802
Last update : 07/07/2015 | Version : 2 | ID : 60060
| General | |
| Identification | |
| Detailed name | Cohort of Children Monitored After First Episode of Acute Demyelination |
| Sign or acronym | KIDSEP |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°60060 |
| General Aspects | |
| Medical area |
Immunology Neurology |
| Health determinants |
Genetic |
| Keywords | multivariate analysis, Health episodes, child, epidemiology |
| Scientific investigator(s) (Contact) | |
| Name of the director | Mikaeloff |
| Surname | Yann |
| Phone | + 33 (0)6 64 31 20 97 ou +33 (0)1 45 21 31 32 |
| yann.mikaeloff@bct.aphp.fr | |
| Unit | E109/U802 |
| Organization | APHP |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Association pour la Recherche sur la Sclérose en Plaques (ARSEP, France) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | APHP |
| 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: 01/01/2010 |
| Database objective | |
| Main objective | General objective: 1. To follow a national cohort of children from their first episode of acute demyelination and monitor them for over 10 years 2. To determine the clinical and radiological risk factors of recurrence (qualified by MS diagnosis) 3. To determine the progression towards disability and its risk factors 4. To participate in a genetic study regarding MS susceptibility 5. Pharmacovigilance (vaccines) |
| Inclusion criteria | Children who have experienced clinical symptoms of acute inflammatory demyelination (A1) between January 1990 and December 2003 before the age of 16. |
| Population type | |
| Age |
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 (11 centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/1990 |
| Date of last collection (YYYY or MM/YYYY) | 01/2015 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 493 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Imaging |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 10 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=KIDSEP |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may not be used by academic teams Data may not be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
