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

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ClinicalTrials.gov Identifier: NCT04454892
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
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;

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Other: Amyotrophic lateral sclerosis

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study on the Natural History and Clinical Features of Amyotrophic Lateral Sclerosis (ALS) in Mainland China
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 1, 2030
Estimated Study Completion Date : December 1, 2030


Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years to 10 years after recruitment ]
    Time interval from disease diagnosis to death

  2. Indicators of disease progression [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Serum and plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ALS patients in mainland China.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454892


Contacts
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Contact: Lu Tang, Msc 13811854649 tanglu@bjmu.edu.cn

Locations
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China
Peking University Third Hospital Recruiting
Beijing, China
Contact: Dongsheng Fan, PHD. MD         
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: Dongsheng Fan, MD.PHD Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04454892    
Other Study ID Numbers: PUTH2019388
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
amyotrophic lateral sclerosis; Epidemiology
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases