Lorraine Registry of Multiple Sclerosis

NCT ID: NCT02883335

Last Updated: 2023-02-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2030-01-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Observational registry

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Having a confirmed multiple sclerosis diagnosis
* Living in Lorraine (French region)

Exclusion Criteria

* Refusal to be registered
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University of Lorraine

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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GUILLEMIN Francis, MD

Médecine coordonateur de module

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Francis Guillemin, MD, PHD

Role: CONTACT

Jonathan Epstein, MD, MSc

Role: CONTACT

Facility Contacts

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Jonathan Epstein, MD, MSc

Role: primary

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.

Reference Type BACKGROUND
PMID: 23816638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21071951 (View on PubMed)

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.

Reference Type RESULT
PMID: 22354740 (View on PubMed)

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.

Reference Type RESULT
PMID: 25966681 (View on PubMed)

Other Identifiers

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RELSEP

Identifier Type: -

Identifier Source: org_study_id

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