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Lorraine Registry of Multiple Sclerosis (RelSEP)

C

Central Hospital, Nancy, France

Status

Enrolling

Conditions

Multiple Sclerosis

Treatments

Other: Observational registry

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

6,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Refusal to be registered

Trial contacts and locations

1

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Central trial contact

Jonathan Epstein, MD, MSc; Francis Guillemin, MD, PHD

Data sourced from clinicaltrials.gov

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