Prognostic Value of Three New Biomarkers of Multiple Sclerosis in Patients With Radiologically Isolated Syndrome (T-RIS)

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Radiologically Isolated Syndrome
• Intervention / Treatment: Other: Analysis of cerebrospinal fluid and serum

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from whom prospective samples have been collected and conserved in the biobank at Nice as part of the RISC (Radiologically Isolated Syndrome Consortium).

100 patients with Radiologically Isolated Syndrome as diagnosed by MRI using the Okuda 2009 criteria (65 RIS-: not converted after at least 2 years of follow-up; 35 RIS+).

30 patients with recurrent-remittent multiple sclerosis 30 symptomatic control patients 20 control patients with inflammatory disease 20 control patients with non-inflammatory neurological disease

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of tumour necrosis factor receptor in cerebrospinal fluid	ELISA	Baseline
Level of Neurofilament in cerebrospinal fluid	ELISA	Baseline
Level of GFAP in cerebrospinal fluid	ELISA	Baseline
Level of secreted glycoprotein in cerebrospinal fluid	ELISA	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of tumour necrosis factor receptor in serum	ELISA	Baseline
Level of Neurofilament in serum	ELISA	Baseline
Level of GFAP in serum	ELISA	Baseline
Level of secreted glycoprotein in serum	ELISA	Baseline
Comparison of the conversion time according to the threshold value of each biomarker for Radiologically Isolated Syndrome patients	Log-rank test	Baseline
Compare prognostic value of all four markers of the high risk criteria (age below 37, male, myelitis).	Multivariate analysis	Baseline
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease; Multiple Sclerosis; Sclerosis; Syndrome
• Other Study ID Numbers: NIMAO/2016/ET-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No