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

NCT04454892 | Recruiting

• 1 other identifier: PUTH2019388
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis; Epidemiology

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Time interval from disease diagnosis to death

  5 years to 10 years after recruitment

• 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

Study Arms (1)

Amyotrophic lateral sclerosis patients

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

Other: Amyotrophic lateral sclerosis

Interventions

Amyotrophic lateral sclerosis OTHER

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

Amyotrophic lateral sclerosis patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS patients in mainland China.

You may qualify if:

• \- 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.

You may not qualify if:

• Decline to follow-up.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dongsheng Fan, MD.PHD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Tang, Msc

CONTACT

13811854649; tanglu@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: November 1, 2019
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)