We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Registered Cohort Study on Amyotrophic Lateral Sclerosis

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: NCT04008329
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Amyotrophic lateral sclerosis (ALS) is a kind of motor neuron degeneration disorder without effective therapy. This registered cohort study will provide further insights into the clinical course of ALS, and investigate disease-relative risk factors and the genetic background of Chinese ALS patients.

Condition or disease
Amyotrophic Lateral Sclerosis

Detailed Description:
Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease (MND), which is characterized with highly clinical heterogeneity and no effective treatment is available now. The purpose of this registered cohort is to observe the natural history of ALS patients in China, and then identify some factors correlated with disease progression. Besides, ALS-related gene mutations will be screened and explore novel disease causing gene as well.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registered Cohort Study on Amyotrophic Lateral Sclerosis
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : July 2029
Estimated Study Completion Date : July 2059

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Age at death [ Time Frame: 10 years ]
    the time when patient die

  2. Age of endotracheal intubation or tracheotomy [ Time Frame: 10 years ]
    the time for the patient accepted endotracheal intubation or tracheotomy


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 who are diagnosed in the First Affiliated Hospital of Fujian Medical University
Criteria

Inclusion Criteria:

  • Amyotrophic Lateral Sclerosis patients fulfilling the El Escorial criteria (including definite, probable and possible)
  • Progressive muscular atrophy
  • Primary lateral sclerosis
  • Progressive bulbar palsy

Exclusion Criteria:

  • History of serious head trauma or neuropsychiatric disease
  • Decline to participate
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04008329


Contacts
Layout table for location contacts
Contact: Qi-Jie Zhang, PhD 086-591-87982772 qijiezhang86@fjmu.edu.cn

Locations
Layout table for location information
China, Fujian
Department of Neurology, First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350005
Contact: Qi-Jie Zhang, PhD    086-591-87982772    qijiezhang86@fjmu.edu.cn   
Contact: Ning Wang, PhD    086-591-87982772    nwang900@yahoo.com   
Principal Investigator: Ning Wang, MD,PhD         
Sub-Investigator: Wan-Jian Chen         
Sponsors and Collaborators
First Affiliated Hospital of Fujian Medical University
Investigators
Layout table for investigator information
Principal Investigator: Ning Wang, MD,PhD First Affiliated Hospital of Fujian Medical University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ning Wang, MD., PhD., Professor, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT04008329    
Other Study ID Numbers: MRCTA,ECFAH of FMU [2019]191
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University:
amyotrophic lateral sclerosis
natural history
genetics
prognostic factors
Additional relevant MeSH terms:
Layout table for MeSH terms
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