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

Study Locations

      • Shanghai, China, 200040
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
          • Changlu Wang, MD
          • Phone Number: 86-021-22200000
      • Shanghai, Shanghai, China, 201102
        • Recruiting
        • Children's Hospital of Fudan University
        • Contact:
          • Wenhui Li, MD
          • Phone Number: 86-021-64931923
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Obsterics and Gynecology Hospital of Fudan University
        • Contact:
          • Weirong Gu, MD
          • Phone Number: 86-021-33189900

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.

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

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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