- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02883335
Lorraine Registry of Multiple Sclerosis (RelSEP)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Nancy, France, 54000
- Recruiting
- CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Having a confirmed multiple sclerosis diagnosis
- Living in Lorraine (French region)
Exclusion Criteria:
- Refusal to be registered
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
case occurence of multiple sclerosis
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
EDSS score
Time Frame: 30 years
|
30 years
|
Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RELSEP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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