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Lorraine Registry of Multiple Sclerosis (RelSEP)

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ClinicalTrials.gov Identifier: NCT02883335
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : August 21, 2018
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
University of Lorraine
Information provided by (Responsible Party):
GUILLEMIN Francis, MD, Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Observational registry

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: Lorraine Registry of Multiple Sclerosis
Study Start Date : May 2003
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. case occurence of multiple sclerosis [ Time Frame: one year ]

Secondary Outcome Measures :
  1. EDSS score [ Time Frame: 30 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from multiple sclerosis in Lorraine
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to be registered

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883335


Contacts
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Contact: Francis Guillemin, MD, PHD francis.guillemin@chru-nancy.fr
Contact: Jonathan Epstein, MD, MSc j.epstein@chru-nancy.fr

Locations
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France
CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy Recruiting
Nancy, France, 54000
Contact: Jonathan Epstein, MD, MSc       j.epstein@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Institut National de la Santé Et de la Recherche Médicale, France
University of Lorraine
Investigators
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Principal Investigator: Francis Guillemin, MD, PHD CHRU Nancy

Additional Information:

Publications of Results:
Other Publications:
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Responsible Party: GUILLEMIN Francis, MD, Médecine coordonateur de module, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02883335     History of Changes
Other Study ID Numbers: RELSEP
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: open to partnership
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases