Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
1 other identifier
observational
500
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
May 28, 2025
May 1, 2025
4 years
August 23, 2020
May 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myasthenia gravis foundation of America post intervention status
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 Outcomes (3)
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scores at the follow up
Baseline, 1 year, 2 year, and 3 year
Change From Baseline in Activities of Daily Living (ADL) Scores at the follow up
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
Baseline, 1 year, 2 year, and 3 year
Study Arms (1)
myasthenia gravis
300 MG patients are anticipated for precision diagnosis and disease monitoring.
Interventions
To detect disease-related biomarkers and omics data, in this prospective MG cohort.
Eligibility Criteria
Patients from the outpatient clinics and inpatient wards are planned to be enrolled, as long as meeting the inclusion criteria.
You may qualify if:
- 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.
You may not qualify if:
- excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc;
- poor compliance to the follow up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Study Sites (4)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200000, China
Obsterics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Huashan Hospital
Shanghai, 200040, China
Related Publications (2)
Jin L, Zou Z, Wang Q, Zeng W, Jiang Q, Chen J, Shi J, Yu Y, Hong D, Zeng Q, Tan S, Yue Y, Zhang Z, Zhang Y, Guo X, Du L, Zhao Z, Huang S, Chen Y, Wu Z, Yan C, Xi J, Song J, Luo S, Zhao C. Patterns and predictors of therapeutic response to efgartigimod in acetylcholine receptor-antibody generalized myasthenia gravis subtypes. Ther Adv Neurol Disord. 2025 Feb 18;18:17562864251319656. doi: 10.1177/17562864251319656. eCollection 2025.
PMID: 39974170DERIVEDJin L, He D, Zeng Q, Tan S, Shi J, Liu Y, Zou Z, Song J, Yan C, Huan X, Wang Y, Yang L, Xi J, Wu Z, Liu Z, Zheng J, Zhao C, Chu X, Luo S. Eculizumab in thymoma-associated myasthenia gravis: a real-world cohort study. Ther Adv Neurol Disord. 2024 Dec 25;17:17562864241309431. doi: 10.1177/17562864241309431. eCollection 2024.
PMID: 39735403DERIVED
Biospecimen
1. Blood samples （Plasma/Serum/RNA/whole blood） 2. Thymus/thymoma tissues obtained during thymic surgery 3. Intercostal muscle specimens obtained during thymic surgery 4. Lymph node samples obtained during thymic surgery
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chongbo Zhao, MD
Huashan Hospital, Shanghai,China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 23, 2020
First Posted
September 2, 2020
Study Start
February 1, 2024
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
May 28, 2025
Record last verified: 2025-05