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

NCT07256431 | Completed

• 1 other identifier: LOCAL/2025/PROBIORIS/EBVD
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiologically Isolated Syndrome; Epstein-Barr Virus Infections

Outcome Measures

Primary Outcomes (3)

• Prevalence of EBV seropositivity in RIS patients

  Measured by single-molecule array (SIMOA)

  Baseline

• Serum vitamin D levels in patients with RIS

  Measured with mass spectrometry

  Baseline

• Disease activity in patients with RIS

  Evidence of disease aftivity versus no evidence of disease activity

  Baseline

Secondary Outcomes (1)

• Prevalence of EBV seropositivity in healthy controls

  Baseline

Study Arms (2)

Patients with radiologically isolated syndrome

Other: Antibiody titration

Healthy controls

Other: Antibiody titration

Interventions

Antibiody titration OTHER

Search for EBV seropositivity using SIMAO assay

Healthy controls; Patients with radiologically isolated syndrome

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with RIS taken from ProBioRIS cohort (NCT06395662) plus healthy controls taken from the VDSS study (NCT05654818).

You may qualify if:

• 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.

You may not qualify if:

• Insufficient sample

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples already in biobanks

MeSH Terms

Conditions

Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Eric Thouvenot

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: August 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

FR (1)