A Study on the Natural History and Clinical Features of Amyotrophic Lateral Sclerosis (ALS) in Mainland China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
- Describe the distribution of ALS in mainland China, to explore the differences in the number of ALS in different times, regions and populations in order to further explore the causes affecting the distribution of ALS;
- To investigate the cause of ALS in mainland China in the crowd disease development process and the corresponding characteristics change ;
- To explore the effect of prognosis of ALS;
详细描述
With the development of supportive measures, the natural history of ALS has changed. Researchers compared the natural history of ALS patients from 1999-2004 and 1984-1998 and found that the median survival time was significantly longer in the former than in the latter (4.32 years vs. 3.22 years) and that the disease progression was slower in the former, even after adjusting for other confounding factors. Although previous studies have provided reference for the diagnosis and treatment of ALS, the etiology of ALS is still unknown, and the relevant clinical features and natural history of ALS still lack the verification of large samples. Therefore, the research on the natural history of ALS is of great significance to further increase the understanding of ALS and provide new evidence for the diagnosis and treatment of ALS.
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
- 否
入选标准
- •Patients were diagnosed with ALS recruited from all participant clinical centers.The diagnosis of ALS was made using the revised El Escorial criteria for definite, probable, lab-supported, and possible.
排除标准
- •Decline to follow-up.
结局指标
主要结局
Overall Survival
时间窗: 5 years to 10 years after recruitment
Time interval from disease diagnosis to death
Indicators of disease progression
时间窗: 1 year to 10 years after recruitment
1) in the diagnosis of disease progression (⊿ FS) = (diagnosis of FRS - R score - when follow-up FRS - R)/diagnosis and follow-up time 2）Weight loss =(weight at diagnosis - weight at follow-up)/time to follow-up 3) BMI decreased = (BMI) at the time of diagnosis of BMI - follow-up/diagnosis and follow-up time 4) FVC decreased = (FVC - during the diagnosis to follow-up FVC)/diagnosis and follow-up time 5) between the above indexes can also be in all follow-up multiple numerical calculation, observing the trend of the change over time
次要结局
未报告次要终点