Clinical trial NCT02883335: Lorraine Registry of Multiple Sclerosis
Official title: Lorraine Registry of Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: University of Lorraine
First posted: 2016-08-30
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from multiple sclerosis in Lorraine

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Refusal to be registered

Primary outcomes:
measure: case occurence of multiple sclerosis
timeFrame: one year
Secondary outcomes:
measure: EDSS score
timeFrame: 30 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy
Study officials:
affiliation: CHRU Nancy
name: Francis Guillemin, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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 2012 Feb 21.
citation: 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.