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OpenTrials
Completed

NCT Number: NCT03357887

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

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

Completed

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Radiologically Isolated Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analysis of cerebrospinal fluid and serum

Other

Analysis of biomarkers in patient biological samples

Primary outcomes

  1. Level of tumour necrosis factor receptor in cerebrospinal fluid

    Time frame: Baseline

    ELISA

  2. Level of Neurofilament in cerebrospinal fluid

    Time frame: Baseline

    ELISA

  3. Level of GFAP in cerebrospinal fluid

    Time frame: Baseline

    ELISA

  4. Level of secreted glycoprotein in cerebrospinal fluid

    Time frame: Baseline

    ELISA

Secondary outcomes

  1. Level of tumour necrosis factor receptor in serum

    Time frame: Baseline

    ELISA

  2. Level of Neurofilament in serum

    Time frame: Baseline

    ELISA

  3. Level of GFAP in serum

    Time frame: Baseline

    ELISA

  4. Level of secreted glycoprotein in serum

    Time frame: Baseline

    ELISA

  5. Comparison of the conversion time according to the threshold value of each biomarker for Radiologically Isolated Syndrome patients

    Time frame: Baseline

    Log-rank test

  6. Compare prognostic value of all four markers of the high risk criteria (age below 37, male, myelitis).

    Time frame: Baseline

    Multivariate analysis

  7. 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)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: T-RIS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2017
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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