Lorraine Registry of Multiple Sclerosis (RelSEP)

February 6, 2023 updated by: GUILLEMIN Francis, MD, Central Hospital, Nancy, France
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.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Recruiting
        • CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from multiple sclerosis in Lorraine

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to be registered

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
University of Lorraine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (ANTICIPATED)

January 1, 2030

Study Completion (ANTICIPATED)

January 1, 2030

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (ESTIMATE)

August 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

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)?

YES

IPD Plan Description

open to partnership

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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