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Prognostic Value of Three New Biomarkers of Multiple Sclerosis in Patients With Radiologically Isolated Syndrome

Prognostic Value of Three New Biomarkers of Multiple Sclerosis Compared to Reference Biomarker in Patients With Radiologically Isolated Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03357887
Acronym
T-RIS
Enrollment
100
Registered
2017-11-30
Start date
2018-07-01
Completion date
2018-12-31
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Radiologically Isolated Syndrome

Brief summary

To look at the prognostic value of new biomarkers in CSF and serum for characterisation of multiple sclerosis

Interventions

OTHERAnalysis of cerebrospinal fluid and serum

Analysis of biomarkers in patient biological samples

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients have given their free consent for use of their samples in research * Patients have at least 2 years of clinical and radiological follow-up data available Exclusion criterion * No follow-up of patients

Design outcomes

Primary

MeasureTime frameDescription
Level of GFAP in cerebrospinal fluidBaselineELISA
Level of secreted glycoprotein in cerebrospinal fluidBaselineELISA
Level of tumour necrosis factor receptor in cerebrospinal fluidBaselineELISA
Level of Neurofilament in cerebrospinal fluidBaselineELISA

Secondary

MeasureTime frameDescription
Level of GFAP in serumBaselineELISA
Level of secreted glycoprotein in serumBaselineELISA
Comparison of the conversion time according to the threshold value of each biomarker for Radiologically Isolated Syndrome patientsBaselineLog-rank test
Compare prognostic value of all four markers of the high risk criteria (age below 37, male, myelitis).BaselineMultivariate analysis
Biomarker levels in CSF and serum in different patient subpopulations (Radiologically Isolated Syndrome, recurrent remittent MS, symptomatic controls, central nervous system inflammatory disease controls, non-inflammatory disease controls)Baseline
Level of tumour necrosis factor receptor in serumBaselineELISA
Level of Neurofilament in serumBaselineELISA

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026