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NCT Number: NCT04454892

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

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;

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, China

Location status: Recruiting

Location contact

Dongsheng Fan, PHD. MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  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

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Tang, Msc

CONTACT

[email protected]

13811854649

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Jul 2, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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