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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Jun 7, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the levels of two substances in the blood, called neurofilament-light chain (NfL) and glial fibrillary acidic protein (GFAP), in patients with Multiple Sclerosis (MS). The researchers believe that measuring these substances can help understand how active and severe a patient's MS is at different stages of the disease. This information could potentially guide treatment and improve patient care.

To participate in the study, patients must be at least 15 years old and have a confirmed diagnosis of MS. They should also be part of the OFSEP cohort and have varying levels of disability, as measured by a specific scoring system. Participants will be asked to provide their consent and may be required to answer some questionnaires. Importantly, the study is currently recruiting patients, so if you or someone you know meets these criteria and is interested, it might be a good opportunity to contribute to important MS research.

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Eligibility 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.