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ProBioRIS

Improving the Stratification of Risks of Conversion of Radiologically Isolated Syndromes (RIS) by Identifying Biomarkers in Serum and Cerebrospinal Fluid. The ProBioRIS Study
CompletedEarly (CIS/RIS)NCT06395662

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 15 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Observational

What it measured

Main measures

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

    Week 0

    Blood or spinal fluid markers

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

    Week 96

    Blood or spinal fluid markers

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

    Week 0

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

    Week 96

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

    Week 0

    Blood or spinal fluid markers

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

    Week 96

    Blood or spinal fluid markers

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

    Week 0

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

    Week 96

Other measures (16)

  • Aim 2a: Kappa free light chain (KFLC) index in RIS patients in the SFSEP, OFSEP and ARISE cohorts, n=121

    Week 0

    RelapsesMRI lesionsBrain volume lossBlood or spinal fluid markersImmune response

  • Aim 2a: Kappa free light chain (KFLC) index in RIS patients in the SFSEP, OFSEP and ARISE cohorts, n=121

    Week 96

    RelapsesMRI lesionsBrain volume lossBlood or spinal fluid markers

  • Aim 2a: Cerebrospinal fluid neurofilament light chain as a potential biomarker of RIS.

    Week 0

    Blood or spinal fluid markersImmune response

  • Aim 2a: Cerebrospinal fluid neurofilament light chain as a potential biomarker of RIS.

    Week 96

    Blood or spinal fluid markersImmune response

  • Aim 2a: Chitinase-3-like protein 1 as a potential biomarker of RIS.

    Week 0

    Blood or spinal fluid markersImmune response

  • Aim 2a: Chitinase-3-like protein 1 as a potential biomarker of RIS.

    Week 96

    Blood or spinal fluid markersImmune response

  • Aim 2a: Oligoclonal bands as a potential biomarker of RIS.

    Week 0

    Blood or spinal fluid markers

  • Aim 2a: Oligoclonal bands as a potential biomarker of RIS.

    Week 96

    Blood or spinal fluid markers

  • Aim 2b: Validation of cerebrospinal fluid neurofilament light chain as a potential biomarker of RIS.

    Week 0

    Blood or spinal fluid markers

  • Aim 2b: Validation of cerebrospinal fluid neurofilament light chain as a potential biomarker of RIS.

    Week 96

    Blood or spinal fluid markers

Who could take part

Early (CIS/RIS)

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    Linked trials

    Links found where a registry record names another trial's registry number.

    History

      1. Started

        Apr 2024

      2. Main results due

        Jul 2025

      3. Finished

        Jul 2025

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