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

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ClinicalTrials.gov Identifier: NCT03357887
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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

Condition or disease Intervention/treatment
Multiple Sclerosis Radiologically Isolated Syndrome Other: Analysis of cerebrospinal fluid and serum

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognostic Value of Three New Biomarkers of Multiple Sclerosis Compared to Reference Biomarker in Patients With Radiologically Isolated Syndrome
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Analysis of cerebrospinal fluid and serum
    Analysis of biomarkers in patient biological samples


Primary Outcome Measures :
  1. Level of tumour necrosis factor receptor in cerebrospinal fluid [ Time Frame: Baseline ]
    ELISA

  2. Level of protein X in cerebrospinal fluid [ Time Frame: Baseline ]
    ELISA

  3. Level of protein Y in cerebrospinal fluid [ Time Frame: Baseline ]
    ELISA

  4. Level of secreted glycoprotein in cerebrospinal fluid [ Time Frame: Baseline ]
    ELISA


Secondary Outcome Measures :
  1. Level of tumour necrosis factor receptor in serum [ Time Frame: Baseline ]
    ELISA

  2. Level of protein X in serum [ Time Frame: Baseline ]
    ELISA

  3. Level of protein Y 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 ]

Biospecimen Retention:   Samples With DNA
Blood and cerebrospinal fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357887


Contacts
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Contact: Eric Thouvenot +33 (0)4 66 68 32 61 eric.thouvenot@chu-nimes.fr

Locations
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France
CHU Nimes Recruiting
Nîmes, France, 30029
Contact: Anissa Megzari       drc@chu-nimes.fr   
Principal Investigator: Eric Thouvenot, MD         
Sub-Investigator: Giovanni Castelnovo, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Eric Thouvenot CHU Nimes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03357887     History of Changes
Other Study ID Numbers: NIMAO/2016/ET-01
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Sclerosis
Multiple Sclerosis
Disease
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases