Lorraine Registry of Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— RelSEP  

Official title:

Lorraine Registry of Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02883335
• Other study ID #: RELSEP
• Status: Recruiting
• Start date: May 2003
• Est. completion date: January 2030

Study information

• Verified date: February 2023
• Source: Central Hospital, Nancy, France
• Contact: Francis Guillemin, MD, PHD
• Email: francis.guillemin[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal to be registered

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Observational registry

Locations

Country	Name	City	State
France	CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy	Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Institut National de la Santé Et de la Recherche Médicale, France, University of Lorraine

Country where clinical trial is conducted

France, 

References & Publications (4)

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 — View Citation

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. — View Citation

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. — View Citation

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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	case occurence of multiple sclerosis		one year
Secondary	EDSS score		30 years