Environmental Risk Factors in Multiple Sclerosis Development: Epidemiological Study of EBV Infection and Vitamin D Deficiency in RIS Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07256431

Acronym

RIS - EBVD

Enrollment

110

Registered

2025-12-01

Start date

2023-08-01

Completion date

2024-07-30

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epstein-Barr Virus Infections, Radiologically Isolated Syndrome

Brief summary

This is an ancillary study using samples collected in the ProBioRIS cohort (NCT06395662). The aim of the project is to highlight new biomarker candidates to assess the risk of conversion to clinically definite multiple sclerosis (CDMS) and disease activity (Evidence of Disease Activity) by taking into account demographic, clinical and MRI parameters. A cohort of healthy subjects will be integrated into the study to serve as a control population. We will study a panel of serum immunoglobulins targeting different Epstein Barr virus antigens to identify latency or reactivation phases. Identifying and prioritizing risk factors for clinical conversion to MS in radiologically isolated syndrome patients is of major importance for the implementation of personalized monitoring and treatment strategies, especially following the recent highlighting of the benefit of background treatments in patients at high risk of CDMS.

Interventions

OTHERAntibiody titration

Search for EBV seropositivity using SIMAO assay

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* RIS patients from the ProBioRIS study with sufficient serum residuals for vitamin D testing and complete EBV serology. * Healthy subjects who participated in the VDSS trial and who provided consent for the use, for basic research purposes, of human biological samples collected during the trial.

Exclusion criteria

• Insufficient sample

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of EBV seropositivity in RIS patients	Baseline	Measured by single-molecule array (SIMOA)
Serum vitamin D levels in patients with RIS	Baseline	Measured with mass spectrometry
Disease activity in patients with RIS	Baseline	Evidence of disease aftivity versus no evidence of disease activity

Secondary

Measure	Time frame	Description
Prevalence of EBV seropositivity in healthy controls	Baseline	Measured by single-molecule array (SIMOA)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026