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出境医 / 临床实验 / A Registered Cohort Study on Amyotrophic Lateral Sclerosis

A Registered Cohort Study on Amyotrophic Lateral Sclerosis

Study Description
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
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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
Arms and Interventions
Outcome Measures
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
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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 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

Contacts
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Contact: Qi-Jie Zhang, PhD 086-591-87982772 qijiezhang86@fjmu.edu.cn

Locations
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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
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Principal Investigator: Ning Wang, MD,PhD First Affiliated Hospital of Fujian Medical University
Tracking Information
First Submitted Date July 1, 2019
First Posted Date July 5, 2019
Last Update Posted Date March 22, 2021
Actual Study Start Date July 5, 2019
Estimated Primary Completion Date July 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 2, 2019)
  • Age at death [ Time Frame: 10 years ]
    the time when patient die
  • Age of endotracheal intubation or tracheotomy [ Time Frame: 10 years ]
    the time for the patient accepted endotracheal intubation or tracheotomy
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Registered Cohort Study on Amyotrophic Lateral Sclerosis
Official Title A Registered Cohort Study on Amyotrophic Lateral Sclerosis
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ALS patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University
Condition Amyotrophic Lateral Sclerosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 2, 2019) 		2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2059
Estimated Primary Completion Date July 2029   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Qi-Jie Zhang, PhD 086-591-87982772 qijiezhang86@fjmu.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04008329
Other Study ID Numbers MRCTA,ECFAH of FMU [2019]191
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University
Study Sponsor First Affiliated Hospital of Fujian Medical University
Collaborators Not Provided
Investigators
Principal Investigator: Ning Wang, MD,PhD First Affiliated Hospital of Fujian Medical University
PRS Account First Affiliated Hospital of Fujian Medical University
Verification Date February 2021

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