Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6000 participants
OBSERVATIONAL
2003-05-31
2030-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Observational registry
Eligibility Criteria
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Inclusion Criteria
* Living in Lorraine (French region)
Exclusion Criteria
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University of Lorraine
OTHER
Central Hospital, Nancy, France
OTHER
Responsible Party
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GUILLEMIN Francis, MD
Médecine coordonateur de module
Principal Investigators
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Francis Guillemin, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
CHRU Nancy
Locations
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CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy
Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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RELSEP
Identifier Type: -
Identifier Source: org_study_id
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