Clinical trial NCT05815108: Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome
Official title: Prevalence and Prognostic Value of Epstein Barr Virus (EBV) Infection in Patients With Radiologically Isolated Syndrome (RIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Radiologically Isolated Syndrome
Epstein-Barr Virus
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 156
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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)).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

none

Primary outcomes:
measure: Comparaison of IgG EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
timeFrame: Retrospectively at baseline (RIS diagnosis)
Secondary outcomes:
measure: Comparaison of IgM VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
timeFrame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
measure: Comparaison of IgG VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
timeFrame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
measure: Prevalence of EBV seropositivity in RIS patients according to their MRI activity
timeFrame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
measure: Prevalence of EBV seropositivity in RIS patients according to their clinical and/or MRI activity (EDA)
timeFrame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
measure: Assessment correlation between antibodies titers and clinical conversion
timeFrame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
measure: Assessment correlation between antibodies titers and clinical and/or MRI activity (EDA)
timeFrame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References: