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A Prospective Cohort Study Of Myasthenia Gravis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674605
Recruitment Status : Unknown
Verified December 2020 by Fei Xiao, First Affiliated Hospital of Chongqing Medical University.
Recruitment status was:  Recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Fei Xiao, First Affiliated Hospital of Chongqing Medical University

Study Description
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Brief Summary:

The average annual incidence of Myasthenia gravis is up to (8.0-20.0) / 100,000 people. Myasthenia gravis is an acquired autoimmune disease. All skeletal muscles of patients may be involved. When ocular muscles are involved, ptosis, diplopia and other symptoms may occur. When the laryngopharyngeal muscles are involved, the patient may develop dysarthria, dysphagia and other symptoms. However, when the respiratory muscles are involved, patients will have difficulty in breathing, and some patients may develope myasthenia crisis, and artificial assisted respiratory therapy is often needed.

This study is a prospective observational study, in which patients are continuously enrolled, basic information of patients is collected, and biological samples are collected. The purpose of this study is to improve the diagnosis and prognosis of myasthenia gravis patients.


Condition or disease Intervention/treatment
Myasthenia Gravis Myasthenia Gravis Crisis Device: biomarkers

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Prospective Cohort Study Of Myasthenia Gravis
Estimated Study Start Date : December 31, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
ocular myasthenia gravis Device: biomarkers
biomarkers
generalized myasthenia gravis Device: biomarkers
biomarkers


Outcome Measures
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Primary Outcome Measures :
  1. Myasthenia gravis foundation of America post intervention status [ Time Frame: 3 years ]
    Complete Stable Remission (CSR) Pharmacologic Remission (PR) Minimal Manifestations (MM) Change in Status: Improved (I) Unchanged (U) Worse (W) Exacerbation (E) Died of MG (D of MG)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chinese
Criteria

Inclusion Criteria:

  • Meeting the diagnosis of myasthenia gravis

Exclusion Criteria:

  • Malignant tumor or other serious chronic disease
Contacts and Locations
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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): NCT04674605


Contacts
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Contact: Fei Xiao, MD 86 23 89012009 feixiao81@126.com

Locations
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China, Chongqing
The First Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400016
Contact: Fei Xiao, MD       feixiao81@126.com   
China, YuZhong District
The First Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, YuZhong District, China, 400016
Contact: Fei Xiao, MD       feixiao86@126.com   
Sponsors and Collaborators
First Affiliated Hospital of Chongqing Medical University
More Information
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Responsible Party: Fei Xiao, Prof.Fei Xiao, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT04674605    
Other Study ID Numbers: 2020-382
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Fei Xiao, First Affiliated Hospital of Chongqing Medical University:
Myasthenia Gravis
Prognostic prediction
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases