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临床试验/NCT07256431
NCT07256431已完成不适用

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

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年8月1日最近更新:
适应症

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)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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