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OpenTrials
Completed

NCT Number: NCT07256431

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

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.

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Key information

Conditions

Radiologically Isolated Syndrome DNA Virus Infections Epstein-Barr Virus Infections Herpesviridae Infections Infections Tumor Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiody titration

Other

Search for EBV seropositivity using SIMAO assay

Primary outcomes

  1. Prevalence of EBV seropositivity in RIS patients

    Time frame: Baseline

    Measured by single-molecule array (SIMOA)

  2. Serum vitamin D levels in patients with RIS

    Time frame: Baseline

    Measured with mass spectrometry

  3. Disease activity in patients with RIS

    Time frame: Baseline

    Evidence of disease aftivity versus no evidence of disease activity

Secondary outcomes

  1. Prevalence of EBV seropositivity in healthy controls

    Time frame: Baseline

    Measured by single-molecule array (SIMOA)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: RIS - EBVD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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