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临床试验/NCT05388331
NCT05388331招募中不适用

The Radiologically Isolated Syndrome International Cohort

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Identification of lesions T2-weighted sequence at the index scan

研究概览

简要总结

The Radiologically Isolated Syndrome (RIS) corresponds to the discovery of white matter (WM) abnormalities suggestive of multiple sclerosis (MS) by their location, size, and appearance, on the brain or spinal cord Magnetic Resonance Imaging (MRI). This imaging is performed for a reason other than for suspicion of demyelinating disease in subjects without a history of neurological symptoms and a strict routine clinical neurological examination. It was defined and named in 2009 (Okuda et al.) after publishing 3 case series (French, USA, Turkey). The Radiologically Isolated Syndrome Consortium (RISC) published a cohort of subjects with an extended follow-up after the first brain MRI of MS, with 34% presenting an event (clinical conversion) at five years, 51.2 % of these subjects showed an event at ten years. The patients who offer a higher risk of developing a first clinical demyelinating event were identified such as male sex, young age, the presence of oligoclonal bands (BOCs) in the Cerebrospinal Fluid (CSF), the presence of infratentorial lesions and spinal cord lesions on the first MRI suggestive of RIS. The location and morphology of the lesions appear to be decisive for studying the risk of conversion. Our first objective is to prospectively collect data to identify the subjects who present a higher risk of developing a first clinical demyelinating event and the progression of the disease in these subjects.

Among the objectives of this worldwide cohort is the analysis of (1) environmental factors (Vit D, EBV, tobacco...), (2) MRI biomarkers, including atrophy, central veins signs, paramagnetic rings, and DTI.

(3) digital biomarkers (4) oculography (5) biological markers To summarize, this cohort will allow for analyzing features in imaging, biology and the exploration of digital and oculographic characteristics to identify predictive factors of clinical evolution of a large cohort of subjects presenting WM abnormalities suggestive of multiple sclerosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • white matter T2 lesions suggestive of demyelination
  • asymptomatic
  • normal neurological exam

排除标准

  • abnormal neurological exam,
  • suspicion of another disease explaining MRI lesions.

结局指标

主要结局

Identification of lesions T2-weighted sequence at the index scan

时间窗: at inclusion

localisation of interest of T2 lesion (juxtacortical, periventricular, infratentorial, spinal cord)

Identification of lesions T1 sequence with and without Gd at the index scan.

时间窗: at inclusion

localisation of interest

Radiological progression : new T2 lesions

时间窗: MS onset assessed up to 2 years

localisation of interest of T2 lesion

Radiological progression : new contrast enhancing lesions

时间窗: MS onset assessed up to 2 years

localisation of interest

Brain atrophy

时间窗: MS onset assessed up to 2 years

measurement of global and regional grey matter volume measurement of global and regional white matter volume

次要结局

  • Collect biological data(MS onset assessed up to 2 years)
  • Collect digital markers(MS onset assessed up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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