Clinical trial · Observational
Environmental Risk Factors in Multiple Sclerosis Development: Epidemiological Study of EBV Infection and Vitamin D Deficiency in RIS Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epstein-Barr Virus Infections | — | UNRESOLVED | — |
| Radiologically Isolated Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antibiody titration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients with radiologically isolated syndrome
- interventionNames
- Other: Antibiody titration
- label
- Healthy controls
- interventionNames
- Other: Antibiody titration
Primary outcomes (3)
- measure
- Prevalence of EBV seropositivity in RIS patients
- timeFrame
- Baseline
- description
- Measured by single-molecule array (SIMOA)
- measure
- Serum vitamin D levels in patients with RIS
- timeFrame
- Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available