Assessment of serum neurofilament-light chain (NfL) and glial fibrillary acidic protein (GFAP) levels, atrophy of the macular ganglion cell complex (GCC) by optical coherence tomography (OCT) and whole brain atrophy by MRI to predict evolution of neurological disability in multiple sclerosis patients
NCT ID NCT04860947
First seen Oct 22, 2026 · Last updated Oct 23, 2026 · Updated 1 time
Summary
The investigators hypothesize that serum neurofilament-light chain (NfL) levels at baseline and decrease of the macular ganglion cell complex (GCC) thickness at one year vs. baseline are as good as progression of whole brain atrophy at one year vs. baseline to predict later evolution of neurological disability in multiple sclerosis patients.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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200 people
The number who actually took part.
- Started
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Jun 2019
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population is composed of consecutive adult patients, of both sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology department of Nîmes University Hospital (CHU). The patients recruited will have an EDSS score comprised between 0 - 7.0.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 (≥)18 years old. * The patient has experienced a CIS, has currently a RRMS or progressive MS with: * Less than 10 years of disease duration; * With or without DMD; * EDSS score 0 - 7.0. Exclusion Criteria: * 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. * Patient has a bilateral optic neuritis or other significant ophthalmological antecedent. * Patient with MRI contra-indications. * patient has a contraindication to gadolinium injection * The patient has bilateral optic neuritis or other significant ophthalmological antecedent * Patient is having a relapse or has had a relapse in the last 3 months * The patient has a severe psychiatric illness * The patient has severe chronic alcoholism
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU de Nimes
Nîmes, 30029, France
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Other studies related to the condition(s) this trial covers.
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- Serum neurofilament-light chain and glial fibrillary acidic proten (GFAP) levels in patients from the OFSEP cohort at different landmarks of multiple sclerosis
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