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Trial Title:
Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome
NCT ID:
NCT05815108
Condition:
Multiple Sclerosis
Radiologically Isolated Syndrome
Epstein-Barr Virus
Conditions: Official terms:
Epstein-Barr Virus Infections
Multiple Sclerosis
Syndrome
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
NO INTERVENTION
Description:
NO INTERVENTION
Arm group label:
RIS Patient
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)).
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
15 Years
Maximum age:
70 Years
Locations:
Facility:
Name:
Nice University Hospital
Address:
City:
Nice
Zip:
06000
Country:
France
Status:
Recruiting
Contact:
Last name:
Cassandre LANDES-CHATEAU
Phone:
33492034126
Email:
landes.c@chu-nice.fr
Investigator:
Last name:
christine LEBRUN-FRENAY
Email:
Principal Investigator
Start date:
March 15, 2023
Completion date:
June 15, 2024
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Nice
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Nice
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05815108
