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临床试验/NCT05077696
NCT05077696Unknown不适用

Contribution of the Neurofilament Assay for the Diagnosis of ALS (Amyotrophic Lateral Sclerosis) in Situations of Diagnostic Standoff After Evaluation in an Expert ALS Center

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 100 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
contribution of pNFH and NFL neurofilaments assays

研究概览

简要总结

The aim of the study is to evaluate the interest of the determination of pNFH and NFL neurofilaments in serum for the diagnosis of ALS in patients with a diagnostic standoff after evaluation in an expert ALS center. The hypothesis is that one of these biomarkers, or their combined analysis, will make it possible to confirm or invalidate the diagnosis of ALS.

详细描述

For this study, which aims to evaluate a test to help in the diagnosis of ALS that could be integrated into routine practice, it was preferred to use blood tests. Blood sampling is significantly less invasive than CSF sampling, and more easily generalized, including in ambulatory conditions.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

contribution of pNFH and NFL neurofilaments assays

时间窗: 1 year

contribution of pNFH and NFL neurofilaments assays in serum for the positive diagnosis of ALS in a selected population of patients with progressive motor neuron disease without definite diagnosis

次要结局

  • Value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone(1 year)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Neurofilament Assay for the Diagnosis of ALS | 临床试验