Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China

NCT ID: NCT04535843

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2028-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myasthenia Gravis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

myasthenia gravis

300 MG patients are anticipated for precision diagnosis and disease monitoring.

Biomarkers and omics data

Intervention Type OTHER

To detect disease-related biomarkers and omics data, in this prospective MG cohort.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biomarkers and omics data

To detect disease-related biomarkers and omics data, in this prospective MG cohort.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
* poor compliance to the follow up.
Minimum Eligible Age

0 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chongbo Zhao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chongbo Zhao, MD

Role: STUDY_CHAIR

Huashan Hospital, Shanghai,China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Obsterics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Huashan Hospital

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chongbo Zhao, MD

Role: CONTACT

86-021-52889999

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Changlu Wang, MD

Role: primary

86-021-22200000

Weirong Gu, MD

Role: primary

86-021-33189900

Wenhui Li, MD

Role: primary

86-021-64931923

Chongbo Zhao, MD

Role: primary

+86 21 52889999

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39974170 (View on PubMed)

Jin 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.

Reference Type DERIVED
PMID: 39735403 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-999

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.