Natural History and Clinical Features of Amyotrophic Lateral Sclerosis (ALS)

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Amyotrophic lateral sclerosis

• Registration Number: NCT04454892
• Lead Sponsor: Peking University Third Hospital

Brief Summary

1. 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;

2. To investigate the cause of ALS in mainland China in the crowd disease development process and the corresponding characteristics change ;

3. To explore the effect of prognosis of ALS;

Detailed Description

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.

Study Timeline

• Study Start: 2019-11-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Last Update Submitted: 2020-06-29
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02
• Primary Completion: 2030-12-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 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.

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Exclusion Criteria

• Decline to follow-up.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amyotrophic lateral sclerosis patients	Amyotrophic lateral sclerosis	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

Primary Outcome Measures

Name	Time	Method
Overall Survival	5 years to 10 years after recruitment	Time interval from disease diagnosis to death
Indicators of disease progression	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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China