- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04535843
Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
January 27, 2024 updated by: Chongbo Zhao, Huashan Hospital
The present study is a prospective cohort study aiming to improve the clinical capacity in the diagnosis and natural history of Chinese patients with myasthenia gravis (MG).
300 MG patients are planned to recruit, document and prospectively follow up.
Management of screening test and cohort manifestation are studied.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chongbo Zhao, MD
- Phone Number: 86-021-52889999
- Email: zhao_chongbo@fudan.edu.cn
Study Locations
-
-
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Shanghai, China, 200040
- Recruiting
- Huashan Hospital
-
Contact:
- Chongbo Zhao, MD
- Phone Number: +86 21 52889999
- Email: zhao_chongbo@fudan.edu.cn
-
-
Shanghai
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Shanghai, Shanghai, China, 200000
- Recruiting
- Shanghai Chest Hospital
-
Contact:
- Changlu Wang, MD
- Phone Number: 86-021-22200000
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Shanghai, Shanghai, China, 201102
- Recruiting
- Children's Hospital of Fudan University
-
Contact:
- Wenhui Li, MD
- Phone Number: 86-021-64931923
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Shanghai, Shanghai, China, 200011
- Recruiting
- Obsterics and Gynecology Hospital of Fudan University
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Contact:
- Weirong Gu, MD
- Phone Number: 86-021-33189900
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 88 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients from the outpatient clinics and inpatient wards are planned to be enrolled, as long as meeting the inclusion criteria.
Description
Inclusion Criteria:
- fluctuating muscle weakness and fatigability, along with one of the below:
- more than 10% amplitude decrement in low frequency repetitive nerve stimulation,less than 10% amplitude increment in high frequency repetitive nerve stimulation;
- anti-AChR or MuSK antibody positivity;
- positive to the neostigmine test;
- understanding and assigning the informed consent form, and having a good compliance with the follow up.
Exclusion Criteria:
- excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc;
- participating other clinical trials;
- poor compliance to the follow up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
myasthenia gravis
300 MG patients are anticipated for precision diagnosis and disease monitoring.
|
Detect the pheripheral biomarkers,including lymphocytes and cytokines, in this prospective MG cohort.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myasthenia gravis foundation of America post intervention status
Time Frame: 3 years
|
Myasthenia gravis foundation of America post intervention status (PIS) is assessed by the investigators during follow up.
According to history inquiry and physical examination, participants are rated as clinical remission (no complain of myasthenia, no weakness at physical examination, and no therapies concerning MG for one year), pharmocological remission (no complain of myasthenia, no weakness at physical examination, but undertaking MG therapies at the last year), minimal manifestation (no complain of weakness, but showing weakness at physical examination), improvement (symptoms and signs), unchanged (symptoms and signs) , worsening(symptoms and signs), exacerbation(symptoms and signs), and death (medical record).
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scores at the follow up
Time Frame: Baseline, 1 year, 2 year, and 3 year
|
A quantitative MG scoring system (QMG Score) is essential in the objective evaluation of therapy for MG.This scoring system is based on quantitative testing of sentinel muscle groups.
Total QMG score range from 0 (extreme disease severity) to 39 (none), higher score indicated less disease severity.
|
Baseline, 1 year, 2 year, and 3 year
|
Change From Baseline in Manual Muscle Testing (MMT) Scores at the follow up
Time Frame: Baseline, 1 year, 2 year, and 3 year
|
The MMT score is the sum of strength or function values assigned by the examining physician to 30 muscle groups usually affected by MG.
Total MMT score range from 0 (none) to 124 (extreme muscle weakness), higher score indicated more disease severity.
|
Baseline, 1 year, 2 year, and 3 year
|
Change From Baseline in Myasthenia Gravis-Quality of Life Questionnaire-15 item (MG-QOL15) Scores at the follow up
Time Frame: Baseline, 1 year, 2 year, and 3 year
|
The MG-QOL15 is helpful in informing the clinician about the patient's perception of the extent of and dissatisfaction with MG-related dysfunction.
Total MG-QOL15 score range from 0 (none) to 60 (extreme disease severity), higher score indicated more disease severity.
|
Baseline, 1 year, 2 year, and 3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Chongbo Zhao, MD, Huashan Hospital, Shanghai,China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2024
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
May 1, 2028
Study Registration Dates
First Submitted
August 23, 2020
First Submitted That Met QC Criteria
August 27, 2020
First Posted (Actual)
September 2, 2020
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 27, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neuromuscular Manifestations
- Nervous System Neoplasms
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Muscle Weakness
- Myasthenia Gravis
Other Study ID Numbers
- 2020-999
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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