Environmental Risk Factors in Multiple Sclerosis Development: Epidemiological Study of EBV Infection and Vitamin D Deficiency in RIS Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Serum vitamin D levels in patients with RIS
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Serum vitamin D levels in patients with RIS
Time Frame: Baseline
Measured with mass spectrometry
Disease activity in patients with RIS
Time Frame: Baseline
Evidence of disease aftivity versus no evidence of disease activity
Prevalence of EBV seropositivity in RIS patients
Time Frame: Baseline
Measured by single-molecule array (SIMOA)
Secondary Outcomes
- Prevalence of EBV seropositivity in healthy controls(Baseline)