CompletedNot Applicable

Stratification of Risks of Conversion of Radiologically Isolated Syndromes (RIS) by Identifying Biomarkers in Serum and Cerebrospinal Fluid.

United States, France320 participantsStarted 2024-04-15

Plain-language summary

Radiologically isolated syndrome (RIS) often precedes Multiple Sclerosis (MS) but some patients have no symptoms. This study aims to use biological samples and magnetic resonance imaging (MRI) data from four large cohorts of patients with MS in the United States, Europe and France, to stratify the chances of RIS developing into MS. Identifying early biomarkers to predict greater disease severity would have a significant impact, not only on RIS but also on the entire clinical spectrum of multiple sclerosis.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients from the OFSEP, SFSEP, RISE and TERIS cohorts with centralized validated radiologoically isolated syndrome and a standardized magnetic resonance imaging from the OFSEP or Randomized Clinical Trials database. * at least one cerebro-spinal fluid and/or serum sample at baseline available at a local or centralized biological resource center. * if present, serum sample collected at the time of clinical conversion. Exclusion Criteria: * patients with no biocollection, or with non-standardized magnetic resonance imaging acquisitions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Aim 1a : Association between Serum Neurofilament Light chain (sNfL) and RIS in all groups of patients

Timeframe: Week 0

Aim 1a : Association between Serum Neurofilament Light chain (sNfL) and RIS in all groups of patients

Timeframe: Week 96

Aim 1a : Association between Serum Glial Fibrillary Astrocytic Protein (sGFAP) and RIS in all groups of patients

Timeframe: Week 0

Aim 1a : Association between Serum Glial Fibrillary Astrocytic Protein (sGFAP) and RIS in all groups of patients

Timeframe: Week 96

Aim 1b: Association between Serum Neurofilament Light chain (sNfL) and RIS in placebo-treated patients

Timeframe: Week 0

Aim 1b: Association between Serum Neurofilament Light chain (sNfL) and RIS in placebo-treated patients

Timeframe: Week 96

Aim 1b : Association between Serum Glial Fibrillary Astrocytic Protein (sGFAP)and RIS in placebo-treated patients

Trial details

NCT IDNCT06395662

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-25

View on ClinicalTrials.gov More Radiologically Isolated Syndrome trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Aim 1a : Association between Serum Neurofilament Light chain (sNfL) and RIS in all groups of patients

Timeframe: Week 0

Aim 1a : Association between Serum Neurofilament Light chain (sNfL) and RIS in all groups of patients

Timeframe: Week 96

Aim 1a : Association between Serum Glial Fibrillary Astrocytic Protein (sGFAP) and RIS in all groups of patients

Timeframe: Week 0

Aim 1a : Association between Serum Glial Fibrillary Astrocytic Protein (sGFAP) and RIS in all groups of patients

Timeframe: Week 96

Aim 1b: Association between Serum Neurofilament Light chain (sNfL) and RIS in placebo-treated patients

Timeframe: Week 0

Aim 1b: Association between Serum Neurofilament Light chain (sNfL) and RIS in placebo-treated patients

Timeframe: Week 96

Aim 1b : Association between Serum Glial Fibrillary Astrocytic Protein (sGFAP)and RIS in placebo-treated patients