NCT05815108

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)).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

2 days

First QC Date

March 8, 2023

Last Update Submit

May 5, 2025

Conditions

Multiple SclerosisRadiologically Isolated SyndromeEpstein-Barr Virus

Outcome Measures

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

    IgG EBNA (negative/positive)

    Retrospectively at baseline (RIS diagnosis)

Secondary Outcomes (6)

  • Comparaison of IgM VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay

    Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

  • Comparaison of IgG VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay

    Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

  • Prevalence of EBV seropositivity in RIS patients according to their MRI activity

    Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

  • 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.

  • Assessment correlation between antibodies titers and clinical conversion

    Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.

  • +1 more secondary outcomes

Study Arms (1)

RIS Patient

RIS patients validated by the RIS expert group

Other: NO INTERVENTION

Interventions

NO INTERVENTIONOTHER

NO INTERVENTION

RIS Patient

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Multiple SclerosisEpstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 18, 2023

Study Start

March 15, 2023

Primary Completion

March 17, 2023

Study Completion

March 17, 2023

Last Updated

May 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)