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Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05815108
Acronym
EBV-RIS
Enrollment
156
Registered
2023-04-18
Start date
2023-03-15
Completion date
2023-03-17
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epstein-Barr Virus, Multiple Sclerosis, Radiologically Isolated Syndrome

Brief summary

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)).

Interventions

OTHERNO INTERVENTION

NO INTERVENTION

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years

Inclusion criteria

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

Exclusion criteria

none

Design outcomes

Primary

MeasureTime frameDescription
Comparaison of IgG EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delayRetrospectively at baseline (RIS diagnosis)IgG EBNA (negative/positive)

Secondary

MeasureTime frameDescription
Comparaison of IgG VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delayRetrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.quantity of IgM VCA EBNA (U/ml)
Prevalence of EBV seropositivity in RIS patients according to their MRI activityRetrospectively 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
Comparaison of IgM VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delayRetrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.quantity of IgM VCA EBNA (U/ml)
Assessment correlation between antibodies titers and clinical conversionRetrospectively 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
Assessment correlation between antibodies titers and clinical and/or MRI activity (EDA)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
Prevalence of EBV seropositivity in RIS patients according to their clinical and/or MRI activity (EDA)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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026