Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome

Multiple Sclerosis Clinical Trial

— EBV-RIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815108
• Other study ID #: 23Neuro01
• Status: Recruiting
• Start date: March 15, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: christine LEBRUN-FRENAY
• Phone: 0492038528
• Email: lebrun-frenay.c[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

none

Related Conditions & MeSH terms

• Epstein-Barr Virus Infections
• Multiple Sclerosis
• Radiologically Isolated Syndrome
• Syndrome

Intervention

Other:
• NO INTERVENTION
NO INTERVENTION

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

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