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Registration Study of Amyotrophic Lateral Sclerosis (ALS) in Mainland China (ChALSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328675
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Brief Summary:
A multi-center registration study of natural history and clinical characteristics of ALS in mainland China

Condition or disease
Amyotrophic Lateral Sclerosis

Detailed Description:
Amyotrophic lateral sclerosis (ALS) is a rapidly progressive neurodegenerative disease of unknown etiology that is currently incurable. This study is a national multi-center registration study. The study collects general information of ALS patients including medical history, disease characteristics, clinical treatment data, and patient information for different visits in different centers. The aim of the study is: a) describe the distribution of ALS in mainland China(explore the differences in the number of ALS at different times, different regions, and different populations) and further find the reasons that affect the distribution of ALS, b) study the development of ALS in mainland China and the corresponding changes in the characteristics of the disease, c) explore factors that influence the prognosis of ALS.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4752 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Registration Study of Natural History and Clinical Characteristics of Amyotrophic Lateral Sclerosis (ALS) in Mainland China
Actual Study Start Date : March 20, 2020
Estimated Primary Completion Date : March 20, 2023
Estimated Study Completion Date : March 20, 2023





Primary Outcome Measures :
  1. Effective Survival [ Time Frame: through study completion, an average of 3 month ]
    The length of time from the date of diagnosis to patient death or tracheotomy or ventilator-assisted breathing.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: through study completion, an average of 3 month ]
    The length of time from the date of diagnosis to patient death due to any cause or the last confirmed survival.

  2. Rate of disease progression [ Time Frame: through study completion, an average of 3 month ]
    The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score from the diagnosis time to the follow-up time. ALSFRS-R values from 0 to 48 and it implies better outcome when it is higher.

  3. Rate of Weight decline [ Time Frame: through study completion, an average of 3 month ]
    The slope of decline of weight

  4. Rate of BMI decline [ Time Frame: through study completion, an average of 3 month ]
    The slope of decline of BMI

  5. Rate of Forced Vital Capacity (FVC) [ Time Frame: through study completion, an average of 3 month ]
    The slope of decline of Forced Vital Capacity (FVC) to assess the respiratory function.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who meet the criteria will be enrolled from multi-centers in mainland China.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria
  • Age: 18-70 years

Exclusion Criteria:

  • Refuse to cooperate or reject the informed consent

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): NCT04328675


Contacts
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Contact: Dongsheng Fan, MD, PhD +86-15611908107 dsfan@sina.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Dongsheng Fan    +861082265032    dsfan@sina.com   
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: NCT04328675    
Other Study ID Numbers: FDongsheng-81873784
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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