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

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Diagnostic Test: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT03981003

CIVI/2018/ET-02

Details and patient eligibility

About

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.

Enrollment: 1,150 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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 landmark criteria for an active MS (relapse, or Expanded Disability Status Scale progression, or active MRI) during follow-up;
  • For Work Package 4: patients with a stable disease enrolled in OFSEP-HD study in Nîmes or Nantes University Hospitals.

Exclusion criteria

• Within the past three months, the patient has participated in another interventional study 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.

Trial design

1,150 participants in 1 patient group

MS Patients

Treatment:

Diagnostic Test: Blood sample