NCT03981003 Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis
| NCT ID | NCT03981003 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,150 participants |
| Start Date | 2019-05-22 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,150 participants in total. It began in 2019-05-22 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Eric Thouvenot
PRINCIPAL INVESTIGATOR
CHU Nimes
Frequently Asked Questions
Who can join the NCT03981003 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03981003 currently recruiting?
Yes, NCT03981003 is actively recruiting participants. Contact the research team at eric.thouvenot@chu-nimes.fr for enrollment information.
Where is the NCT03981003 trial being conducted?
This trial is being conducted at Amiens, France, Besançon, France, Bordeaux, France, Caen, France and 11 additional locations.
Who is sponsoring the NCT03981003 clinical trial?
NCT03981003 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Eric Thouvenot at CHU Nimes. The trial plans to enroll 1,150 participants.
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