Lorraine Registry of Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational registry.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Other Observational registry
Primary outcome measures
- case occurence of multiple sclerosis [Time frame: one year]
Secondary outcome measures (1)
- EDSS score [Time frame: 30 years]
Eligibility criteria
Inclusion criteria
- Having a confirmed multiple sclerosis diagnosis
- Living in Lorraine (French region)
Exclusion criteria
- Refusal to be registered
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy — Nancy
Publications
- Brissart H, Morele E, Baumann C, Perf ML, Leininger M, Taillemite L, Dillier C, Pittion S, Spitz E, Debouverie M. Cognitive impairment among different clinical courses of multiple sclerosis. Neurol Res. 2013 Oct;35(8):867-72. doi: 10.1179/1743132813Y.0000000232. Epub 2013 Jun 19. PMID 23816638
- Brissart H, Sauvee M, Latarche C, Dillier C, Debouverie M. Integration of cognitive impairment in the expanded disability status scale of 215 patients with multiple sclerosis. Eur Neurol. 2010;64(6):345-50. doi: 10.1159/000322140. Epub 2010 Nov 13. PMID 21071951
- El Adssi H, Debouverie M, Guillemin F; LORSEP Group. Estimating the prevalence and incidence of multiple sclerosis in the Lorraine region, France, by the capture-recapture method. Mult Scler. 2012 Sep;18(9):1244-50. doi: 10.1177/1352458512437811. Epub 2012 Feb 21. PMID 22354740
- Becker M, Latarche C, Roman E, Debouverie M, Malaplate-Armand C, Guillemin F. No prognostic value of routine cerebrospinal fluid biomarkers in a population-based cohort of 407 multiple sclerosis patients. BMC Neurol. 2015 May 13;15:79. doi: 10.1186/s12883-015-0330-4. PMID 25966681
Identifiers
NCT: NCT02883335 · RELSEP