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Completed

NCT Number: NCT05815108

Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome

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)).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System DNA Virus Infections Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Epstein-Barr Virus Epstein-Barr Virus Infections Herpesviridae Infections Immune System Diseases Infections Nervous System Diseases Radiologically Isolated Syndrome Tumor Virus Infections Virus Diseases

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice University Hospital

Nice, 06000, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

none

Treatment and study plan

No intervention

Other

NO INTERVENTION

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: EBV-RIS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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