Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome (EBV-RIS)

May 5, 2025 updated by: Centre Hospitalier Universitaire de Nice

Prevalence and Prognostic Value of Epstein Barr Virus (EBV) Infection in Patients With Radiologically Isolated Syndrome (RIS)

The clinical course of RRMS patients is variable. Among RIS-Consortium international cohorts, one third of RIS patients progressed to MS at 5 years and 52.2% at 10 years. Biomarkers predictive of MS conversion are key elements to organize personalized medical care, for both follow-up and treatment strategies. EBV seems to be an interesting candidate regarding its involvement MS pathophysiology. It can be easily assess in blood sample in contrast to others prognostic biomarkers validated in RIS : oligoclonal bands and NfL levels in cerebrospinal fluid and serum. In RIS, treatment targeting EBV could significantly modify the course of the disease. The investigators aim to make the fisrt description of the EBV epidemiology (immunoglobulin (Ig)M and IgG anti-viral capsid antigen (VCA), IgG anti Epstein-Barr nuclear antigen (EBNA)) among RIS patients and to investigate a correlation between the different antibodies' titers (IgM VCA, IgG VCA, IgG EBNA) and the course of the disease (clinical conversion or evidence of disease activity (EDA)).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Nice University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with RIS confirmed by the RIS expert center of the Nice CHU, included in the international cohort of the RIS Consortium for which retrospective serological data are available.

Description

Inclusion Criteria:

Patients with RIS confirmed by the RIS expert center of the Nice CHU; EBNA status at RIS diagnosis available

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RIS Patient
RIS patients validated by the RIS expert group
Other: NO INTERVENTION
NO INTERVENTION

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparaison of IgG EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
Time Frame: Retrospectively at baseline (RIS diagnosis)
IgG EBNA (negative/positive)
Retrospectively at baseline (RIS diagnosis)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparaison of IgM VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
Time Frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
quantity of IgM VCA EBNA (U/ml)
Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Comparaison of IgG VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
Time Frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
quantity of IgM VCA EBNA (U/ml)
Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Prevalence of EBV seropositivity in RIS patients according to their MRI activity
Time Frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
EBV seropositivity (negative/positive) according clinical event and Dissemination in time and in space
Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Prevalence of EBV seropositivity in RIS patients according to their clinical and/or MRI activity (EDA)
Time Frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
EBV seropositivity (negative/positive) according clinical event and Dissemination in time and in space
Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Assessment correlation between antibodies titers and clinical conversion
Time Frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
quantity of IgG VCA EBNA (U/ml) and IgM VCA EBNA (U/ml) according Dissemination in time and in space
Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Assessment correlation between antibodies titers and clinical and/or MRI activity (EDA)
Time Frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
quantity of IgG VCA EBNA (U/ml) and quantity of IgM VCA EBNA (U/ml) according clinical event and Dissemination in time and in space
Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

March 17, 2023

Study Completion (Actual)

March 17, 2023

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23Neuro01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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