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Measuring serum biomarkers in Multiple Sclerosis patients

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

Observational Centre Hospitalier Universitaire de Nīmes · NCT03981003

This study is testing blood samples from people with Multiple Sclerosis to see if certain proteins can help us understand how the disease is changing and progressing.

Quick facts

Study typeObservational
Enrollment1150 (estimated)
Ages15 Years and up
SexAll
SponsorCentre Hospitalier Universitaire de Nīmes Academic / other
Locations28 sites (Amiens and 27 other locations)
Trial IDNCT03981003 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the levels of serum neurofilament-light chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) in patients with Multiple Sclerosis (MS) at various stages of the disease. By analyzing blood samples from participants, the study seeks to determine how these biomarkers correlate with disease activity and progression. The research will involve patients enrolled in the OFSEP cohort, focusing on those with varying degrees of disability and disease stability. The findings could enhance understanding of MS and improve patient management.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 15 and older who have been diagnosed with Multiple Sclerosis and are part of the OFSEP cohort.

Not a fit: Patients who have participated in another interventional study within the past three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better monitoring and treatment strategies for patients with Multiple Sclerosis.

How similar studies have performed: Previous studies have shown promise in using serum biomarkers like NfL and GFAP for monitoring Multiple Sclerosis, indicating that this approach is supported by existing research.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Amiens and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple SclerosisNeurofilament-light chainGlial fibrillary Acidic Protein
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.