Registration Study of Amyotrophic Lateral Sclerosis (ALS) in Mainland China

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT04328675
• Lead Sponsor: Peking University Third Hospital

Brief Summary

A multi-center registration study of natural history and clinical characteristics of ALS in mainland China

Detailed Description

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-17
• Study Start: 2020-03-20
• Study First Submitted QC: 2020-03-29
• Study First Posted: 2020-03-31
• Last Update Submitted: 2020-04-26
• Last Update Posted: 2020-04-28
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4752

Inclusion Criteria

• Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria
• Age: 18-70 years

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Exclusion Criteria

• Refuse to cooperate or reject the informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effective Survival	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.

Secondary Outcome Measures

Name	Time	Method
Rate of BMI decline	through study completion, an average of 3 month	The slope of decline of BMI
Rate of disease progression	through study completion, an average of 3 month	The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score from the diagnosis time to the follow-up time. ALSFRS-R values from 0 to 48 and it implies better outcome when it is higher.
Rate of Forced Vital Capacity (FVC)	through study completion, an average of 3 month	The slope of decline of Forced Vital Capacity (FVC) to assess the respiratory function.
Overall Survival	through study completion, an average of 3 month	The length of time from the date of diagnosis to patient death due to any cause or the last confirmed survival.
Rate of Weight decline	through study completion, an average of 3 month	The slope of decline of weight

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China