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Lorraine Registry of Multiple Sclerosis — RelSEP  

Multiple Sclerosis Clinical Trial

Official title:
Lorraine Registry of Multiple Sclerosis

Clinical Trial Summary

The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring in Lorraine a French region, and follow up on them for an indefinite duration, registering disease evolution and intercurrent events.

Clinical Trial Description

As every patient registry in France, the RelSEP is periodically (every four years) evaluated by an independent committee. The RelSEP interrogate multiple sources to insure its exhaustiveness : - every neurologists of Lorraine - MS patient network in Lorraine - health insurance data - PMSI (administrative French national database for hospitals) - biological and imagery services in Lorraine Procedures (automatic and manual) are used to eliminate duplicates Once a patient has been identified its medical file are checked by investigators in order to retrieve the relevant information. New MS cases are confirmed by neurologists. Automatics (implemented in EDMUS software)and manual checks are implemented in the registry database, looking for inconsistencies. The following data are registered : - Name, birthname - Sex - Date of birth - Location (town) - Birth location (town) - Profession - Number of siblings - Marital status - Number of children - Date of onset - Date and nature of clinical manifestations - MRI reports - CSF analysis reports - Event-related potential reports - Impairment and disability evolution - Treatments (start and change of drug treatment) - Drugs related events - Cause of treatment discontinuation - Disease progression Every case has a follow up at least every two years. The quality of data is evaluated by periodically auditing cases at random from our database. An annual report on the main data (incidence and prevalence) of MS in Lorraine is produced. Data are also used for observational studies on prognostic factors. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02883335
Study type Observational [Patient Registry]
Source Central Hospital, Nancy, France
Contact Francis Guillemin, MD, PHD
Email francis.guillemin@chru-nancy.fr
Status Recruiting
Phase
Start date May 2003
Completion date January 2030
View Details
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