Registration Study of Natural History and Clinical Characteristics of Amyotrophic Lateral Sclerosis (ALS) in Mainland China
试验速览
- 阶段
- 不适用
- 入组人数
- 4,752
- 试验地点
- 1
- 主要终点
- Effective Survival
研究概览
简要总结
A multi-center registration study of natural history and clinical characteristics of ALS in mainland China
详细描述
Amyotrophic lateral sclerosis (ALS) is a rapidly progressive neurodegenerative disease of unknown etiology that is currently incurable. This study is a national multi-center registration study. The study collects general information of ALS patients including medical history, disease characteristics, clinical treatment data, and patient information for different visits in different centers. The aim of the study is: a) describe the distribution of ALS in mainland China(explore the differences in the number of ALS at different times, different regions, and different populations) and further find the reasons that affect the distribution of ALS, b) study the development of ALS in mainland China and the corresponding changes in the characteristics of the disease, c) explore factors that influence the prognosis of ALS.
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
- 否
入选标准
- •Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria
- •Age: 18-70 years
排除标准
- •Refuse to cooperate or reject the informed consent
结局指标
主要结局
Effective Survival
时间窗: through study completion, an average of 3 month
The length of time from the date of diagnosis to patient death or tracheotomy or ventilator-assisted breathing.
次要结局
- Rate of BMI decline(through study completion, an average of 3 month)
- Rate of disease progression(through study completion, an average of 3 month)
- Rate of Forced Vital Capacity (FVC)(through study completion, an average of 3 month)
- Overall Survival(through study completion, an average of 3 month)
- Rate of Weight decline(through study completion, an average of 3 month)