Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis

Last updated: May 13, 2024
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Scar Tissue

Multiple Sclerosis

Treatment

Blood sample

Clinical Study ID

NCT03981003
CIVI/2018/ET-02
  • Ages > 15
  • All Genders

Study Summary

The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease.

In addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient has been correctly informed.

  • The patient must have given their informed and signed consent.

  • The patient must be insured or beneficiary of a health insurance plan.

  • The patient is at least (≥)15 years old.

  • The patient has MS according to diagnosis criteria (Thompson et al. 2017) and:

  • Participates to the OFSEP-HD cohort (ancillary study);

  • Has a Expanded Disability Status Scale score comprised between 0 - 7.0;

  • With or without Disease Modifying Drug;

  • For Work Package 3: patients enrolled in any OFSEP-HD centre that meet landmarkcriteria for an active MS (relapse, or Expanded Disability Status Scaleprogression, or active MRI) during follow-up;

  • For Work Package 4: patients with a stable disease enrolled in OFSEP-HD studyin Nîmes or Nantes University Hospitals.

Exclusion

Exclusion Criteria:

  • Within the past three months, the patient has participated in another interventionalstudy that may interfere with the results or conclusions of this study.

  • The patient is in an exclusion period determined by a previous study.

  • The patient is under judicial protection.

  • The patient refuses to sign the consent.

  • It is impossible to correctly inform the patient (inability to understand the study,language problem).

  • The patient is pregnant or breast-feeding.

  • The patient is under 15 years old.

  • Inability to answer questionnaires.

  • Clinically isolated syndrome (CIS) that does not meet the criteria of MS.

  • Radiologically isolated syndrome (RIS).

  • Patient with Neuromyelitis optica spectrum disorder.

Study Design

Total Participants: 1150
Treatment Group(s): 1
Primary Treatment: Blood sample
Phase:
Study Start date:
May 22, 2019
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • CHU d'Amiens

    Amiens,
    France

    Site Not Available

  • CHU de Besancon

    Besançon,
    France

    Site Not Available

  • CHU de Bordeaux

    Bordeaux,
    France

    Site Not Available

  • CHU de Caen

    Caen,
    France

    Site Not Available

  • CHU de Clermont Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • Hopital Henri Mondor

    Créteil,
    France

    Site Not Available

  • CHU de Dijon

    Dijon,
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble,
    France

    Site Not Available

  • CHU de Lille

    Lille,
    France

    Site Not Available

  • CHU de Limoges

    Limoges,
    France

    Site Not Available

  • CHU de Lyon

    Lyon,
    France

    Site Not Available

  • Hopital Timone

    Marseille,
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier,
    France

    Site Not Available

  • CHU de Nancy

    Nancy,
    France

    Site Not Available

  • CHU de Nice

    Nice,
    France

    Site Not Available

  • CHU de Nimes

    Nîmes, 30029
    France

    Active - Recruiting

  • Fondation Rothschild

    Paris,
    France

    Site Not Available

  • Hopital Pitie Salpetriere

    Paris,
    France

    Site Not Available

  • Hopital Saint Antoine

    Paris,
    France

    Site Not Available

  • CH de Poissy

    Poissy,
    France

    Site Not Available

  • CHU de Potiers

    Potiers,
    France

    Site Not Available

  • CHU de Rennes

    Rennes,
    France

    Site Not Available

  • CHU de Rouen

    Rouen,
    France

    Site Not Available

  • CHU de Saint Etienne

    Saint-Étienne,
    France

    Site Not Available

  • CHU de Strasbourg

    Strasbourg,
    France

    Site Not Available

  • CHU de Toulouse

    Toulouse,
    France

    Site Not Available

  • CHU de Tours

    Tours,
    France

    Site Not Available

  • CHU de Martinique

    Fort-de-France,
    Martinique

    Site Not Available

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