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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

A Study on the Natural History and Clinical Features of Amyotrophic Lateral Sclerosis (ALS) in Mainland China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04454892
• Other study ID #: PUTH2019388
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: December 1, 2030

Study information

• Verified date: June 2020
• Source: Peking University Third Hospital
• Contact: Lu Tang, Msc
• Phone: 13811854649
• Email: tanglu[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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;

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 1, 2030
• Est. primary completion date: December 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Exclusion Criteria:

• Decline to follow-up.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• Amyotrophic lateral sclerosis
AMYOTROPHIC lateral sclerosis (ALS) is a degenerative disorder of motor neurons in the cortex, brainstem and spinal cord1,2. Its cause is unknown and it is uniformly fatal, typically within five years3

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Time interval from disease diagnosis to death	5 years to 10 years after recruitment
Primary	Indicators of disease progression	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	1 year to 10 years after recruitment