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临床试验/NCT05892822
NCT05892822尚未招募不适用

Amyotrophic Lateral Sclerosis Registry

yilong Wang1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
1
主要终点
Gene Mutation Characteristics of ALS in Chinese

研究概览

简要总结

This study takes amyotrophic lateral sclerosis (ALS) patients as the main research object. Through collecting genetics, imaging and clinical symptoms for Exploratory research, we will construct the gene spectrum of ALS in China, explore unknown pathogenic genes, explore the characteristic image characteristics of ALS, and establish the iPSCs library of ALS, providing resources and basis for the research of pathogenesis and treatment targets of ALS.

详细描述

This study is a multicenter, prospective registration study that will follow up patients with clinically confirmed and suspected amyotrophic lateral sclerosis for a period of 2 years. A total of 1000 patients will be included to dynamically observe the changes in clinical symptoms and signs, imaging, electrophysiology, biomarkers, biological samples and so on, which will construct a genetic profile of ALS in China, explore the etiology and pathogenesis, and establish an iPSCs library, provide a basis for finding treatment targets.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old ≤ age ≤ 80 years old;
  • Patients are diagnosed definite or probable ALS according to the Awaji diagnostic criteria;
  • Sign an informed consent form.

排除标准

  • Unable to cooperate with research or complete follow-up due to geographical or other reasons.

结局指标

主要结局

Gene Mutation Characteristics of ALS in Chinese

时间窗: day 1

Constructing a Chinese ALS genetic information database by collecting genetic information from patients.

The disease development of ALS in the Chinese

时间窗: month 24

Record the progress of patients' clinical symptoms from baseline through 2-year follow-up.

次要结局

  • Exploring the imaging characteristics of ALS in the Chinese(day 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24)
  • Establishing an iPSCs library for ALS in the Chinese(day 1)
  • Analysis of the correlation between electrophysiology characteristics and imaging characteristics of ALS in Chinese(day 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24)

研究者

发起方
yilong Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yilong Wang

Vice-President of Beijing Tiantan Hospital,Chief Scientist of Neurology Center

Beijing Tiantan Hospital

研究点 (1)

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