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Recruiting Observational

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

NCT04454892 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2019-11-01
Last updated
2020-07-02

Condition(s) studied

Amyotrophic Lateral Sclerosis

Investigational drug(s) / intervention(s)

Amyotrophic lateral sclerosis

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

Study 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;

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04454892 on ClinicalTrials.gov ↗ ← All trials in China