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Research summary · AI summary · not yet reviewedHuman studyObservationalTrial registry record – peer review not applicable
Observational Study of Biomarkers in Multiple Sclerosis Patients
The study enrolled 200 adult patients with clinical presentations related to multiple sclerosis (MS), including CIS, RRMS, or progressive MS. It planned to assess changes in specific biomarkers over various follow-up periods but has not yet reported any findings.
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- #MSResearch
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This plain-English summary was written by AI from a trial registry record and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- No results yet
- Outcome
- Not reported
Why it matters
The study aims to evaluate potential biomarkers for MS progression and disability, which could inform future treatments and management strategies for patients with this condition.
What this does not prove
No results are available as of now, and the planned endpoints do not demonstrate any actual findings. This means the study's impact is currently unknown.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Observational
- Participants / samples
- 200 · actual enrolment
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Consecutive adult patients with CIS, RRMS, or progressive MS; ages from 18 years; EDSS score 0 - 7.0.
- Size of effect
- Not reported
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Neurofilament Light Chain; Glial Fibrillary Acidic Protein
- Safety
- Not reported
Original sources
Supporting passages (13)
study phaseStudy type: Observational
subjectsParticipants: people; ages from 18 Years; sex All
sample sizeEnrollment: 200 participants (actual)
populationThe 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.
primary endpointPrimary endpoints: Change in serum Neurofilament Light Chain serum levels since baseline; Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline; Change in Ganglion Cell Complex thickness since baseline; Change in whole brain volume since baseline; Expanded Disability Status Scale
limitationsPlanned enrolment and endpoints are not findings.
biomarkersPrimary endpoints: Change in serum Neurofilament Light Chain serum levels since baseline; Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline; Change in Ganglion Cell Complex thickness since baseline; Change in whole brain volume since baseline; Expanded Disability Status Scale
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
peer reviewedTrial registry record.
study designStudy type: Observational
interventionInterventions: Brain MRI; Spinal Cord MRI; Retinal imaging
follow upFollow-up: Baseline; 1 year; Baseline; 3 years; Inclusion; 6 Months; 1 Year; 2 years; 3 Years; 4 Years; 5 years; any relapse (max 5 years); 1 year; 18 months; 2.5 years; 3.5 years; 4 years; 4.5 years; Any relapse (Maximum 5 years); 18 Months; 5 Years; Any relapse (maximum 5 Years); Any relapse (Maximum 5 Years); Any relapse (maximum 5 years); until end of study (5 years); 6 months; 3 years,; At relapse (maximum 5 years)
sample size basisEnrollment: 200 participants (actual)
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