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Trial record 22 of 677 for:    amyotrophic lateral sclerosis

A Registered Cohort Study on Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT04008329
Recruitment Status : Recruiting
First Posted : July 4, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University

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.

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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





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



Information from the National Library of Medicine

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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

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
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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

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Responsible Party: Ning Wang, MD., PhD., Professor, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT04008329     History of Changes
Other Study ID Numbers: MRCTA,ECFAH of FMU [2019]191
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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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:
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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