Multiple SclerosisT-RISNCT03357887
Prognostic Value of Three New Biomarkers of Multiple Sclerosis in Patients With Radiologically Isolated Syndrome
An observational study of Multiple Sclerosis and Radiologically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
To look at the prognostic value of new biomarkers in CSF and serum for characterisation of multiple sclerosis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Radiologically Isolated Syndrome
- What is being tested?
- Analysis of cerebrospinal fluid and serum
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- Analysis of cerebrospinal fluid and serum
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of cerebrospinal fluid and serumOther
Analysis of biomarkers in patient biological samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of tumour necrosis factor receptor in cerebrospinal fluid
ELISA
Measured: Baseline
Level of Neurofilament in cerebrospinal fluid
ELISA
Measured: Baseline
Level of GFAP in cerebrospinal fluid
ELISA
Measured: Baseline
Level of secreted glycoprotein in cerebrospinal fluid
ELISA
Measured: Baseline
Secondary outcomes (7)
Level of tumour necrosis factor receptor in serum
ELISA
Measured: Baseline
Level of Neurofilament in serum
ELISA
Measured: Baseline
Level of GFAP in serum
ELISA
Measured: Baseline
Level of secreted glycoprotein in serum
ELISA
Measured: Baseline
Comparison of the conversion time according to the threshold value of each biomarker for Radiologically Isolated Syndrome patients
Log-rank test
Measured: Baseline
Compare prognostic value of all four markers of the high risk criteria (age below 37, male, myelitis).
Multivariate analysis
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Jul 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Thouvenot, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357887
- Sponsor's protocol ID
- NIMAO/2016/ET-01
- Acronym
- T-RIS
- Status last verified
- Dec 2020
- First submitted
- 14 Nov 2017
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29564952
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Three New Biomarkers of Multiple Sclerosis Compared to Reference Biomarker in Patients With Radiologically Isolated Syndrome
- ClinicalTrials.gov ID
- NCT03357887
- Acronym / sponsor ID
- T-RIS / NIMAO/2016/ET-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To look at the prognostic value of new biomarkers in CSF and serum for characterisation of multiple sclerosis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of cerebrospinal fluid and serumAnalysis of biomarkers in patient biological samples | Other | – |
Primary outcome
Level of tumour necrosis factor receptor in cerebrospinal fluid
Time frame: Baseline
ELISA
Level of Neurofilament in cerebrospinal fluid
Time frame: Baseline
ELISA
Level of GFAP in cerebrospinal fluid
Time frame: Baseline
ELISA
Level of secreted glycoprotein in cerebrospinal fluid
Time frame: Baseline
ELISA
7 secondary outcomes
Level of tumour necrosis factor receptor in serum
Time frame: Baseline
Level of Neurofilament in serum
Time frame: Baseline
Level of GFAP in serum
Time frame: Baseline
Level of secreted glycoprotein in serum
Time frame: Baseline
Comparison of the conversion time according to the threshold value of each biomarker for Radiologically Isolated Syndrome patients
Time frame: Baseline
Compare prognostic value of all four markers of the high risk criteria (age below 37, male, myelitis).
Time frame: 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)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 29564952Thouvenot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Thouvenot principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Radiologically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of tumour necrosis factor receptor in cerebrospinal fluid (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03357887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.