Environmental Risk Factors in Multiple Sclerosis Development: Epidemiological Study of EBV Infection and Vitamin D Deficiency in RIS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Serum vitamin D levels in patients with RIS
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Insufficient sample
结局指标
主要结局
Serum vitamin D levels in patients with RIS
时间窗: Baseline
Measured with mass spectrometry
Disease activity in patients with RIS
时间窗: Baseline
Evidence of disease aftivity versus no evidence of disease activity
Prevalence of EBV seropositivity in RIS patients
时间窗: Baseline
Measured by single-molecule array (SIMOA)
次要结局
- Prevalence of EBV seropositivity in healthy controls(Baseline)
