- PGRx : Central demyelination
Head :
Grimaldi - Bensouda Lamiae
Last update : 06/18/2012 | Version : 2 | ID : 2383
| General | |
| Identification | |
| Detailed name | PGRx : Central demyelination |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 907.069 |
| General Aspects | |
| Medical area |
Neurology |
| Others (details) | First central demyelinating event, Demyelination, Multiple Sclerosis (MS) |
| Keywords | pharmaco-epidemiology |
| Scientific investigator(s) (Contact) | |
| Name of the director | Grimaldi - Bensouda |
| Surname | Lamiae |
| Address | 10 place de Catalogne, 75014 Paris |
| Phone | 01 55 42 53 00 |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | LA-SER |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | LA-SER |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control study |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Cases of central demyelination are recruited by a network of neurology and pediatric centers and the referents by a network of general practitioners, distributed all across the territory. |
| Database objective | |
| Main objective | Surveillance and assessment of the risk of central demyelination associated with drug or vaccine use in real life situations. |
| Inclusion criteria |
For the cases: patients, males and females aged from 0 to 79 years, having a first central demyelinating event reported by the neurologist, for which the first symptoms of the episode occurred less than 12 months ago. For the controls: patients, males and females aged from 0 to 79 years, having consulted a general practitioner. |
| 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) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | France, Italy, Spain, United Kingdom, Canada |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2007 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 517 cas et 11125 référents |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Phone interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
