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

Recruiting now

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT03981003

Run by

Centre Hospitalier Universitaire de Nīmes

People needed

1150

Starts

2019-05-22

Expected to finish

2028-06-01

Last updated by the study team

2024-05-14

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• CHU de Nimes — Nîmes, France (enrolling)
• CHU de Besancon — Besançon, France
• CHU de Bordeaux — Bordeaux, France
• CHU de Caen — Caen, France
• CHU de Clermont Ferrand — Clermont-Ferrand, France
• Hopital Henri Mondor — Créteil, France
• CHU de Dijon — Dijon, France
• CHU de Grenoble — Grenoble, France
• CHU de Lille — Lille, France
• CHU de Limoges — Limoges, France
• CHU de Lyon — Lyon, France
• Hopital Timone — Marseille, France
• CHU de Montpellier — Montpellier, France
• CHU de Nancy — Nancy, France
• CHU de Nice — Nice, France
• Fondation Rothschild — Paris, France
• Hopital Pitie Salpetriere — Paris, France
• Hopital Saint Antoine — Paris, France
• CH de Poissy — Poissy, France
• CHU de Potiers — Potiers, France
• CHU de Rennes — Rennes, France
• CHU de Rouen — Rouen, France
• CHU de Saint Etienne — Saint-Etienne, France
• CHU de Strasbourg — Strasbourg, France
• CHU de Toulouse — Toulouse, France

Full record on ClinicalTrials.gov

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