Prognostic Value of Three New Biomarkers of Multiple Sclerosis in Patients With Radiologically Isolated Syndrome
T-RIS
1 other identifier
observational
100
1 country
1
Brief Summary
To look at the prognostic value of new biomarkers in CSF and serum for characterisation of multiple sclerosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2017
CompletedFirst Posted
Study publicly available on registry
November 30, 2017
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedDecember 1, 2025
December 1, 2020
6 months
November 14, 2017
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (7)
Level of tumour necrosis factor receptor in serum
Baseline
Level of Neurofilament in serum
Baseline
Level of GFAP in serum
Baseline
Level of secreted glycoprotein in serum
Baseline
Comparison of the conversion time according to the threshold value of each biomarker for Radiologically Isolated Syndrome patients
Baseline
- +2 more secondary outcomes
Interventions
Analysis of biomarkers in patient biological samples
Eligibility Criteria
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
You may qualify if:
- Patients have given their free consent for use of their samples in research
- No follow-up of patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Nimes
Nîmes, 30029, France
Related Publications (1)
Thouvenot E, Hinsinger G, Demattei C, Uygunoglu U, Castelnovo G, Pittion-Vouyovitch S, Okuda D, Kantarci O, Pelletier D, Lehmann S, Marin P, Siva A, Lebrun C. Cerebrospinal fluid chitinase-3-like protein 1 level is not an independent predictive factor for the risk of clinical conversion in radiologically isolated syndrome. Mult Scler. 2019 Apr;25(5):669-677. doi: 10.1177/1352458518767043. Epub 2018 Mar 22.
PMID: 29564952RESULT
Biospecimen
Blood and cerebrospinal fluid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Thouvenot
CHU Nimes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2017
First Posted
November 30, 2017
Study Start
July 1, 2018
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
December 1, 2025
Record last verified: 2020-12