Improving diagnosis and understanding of myasthenia gravis in Chinese patients
Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
This study is trying to improve how doctors diagnose and understand myasthenia gravis in Chinese patients by tracking the health of 300 people with the condition over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 0 Years to 90 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 4 sites (Shanghai, Shanghai Municipality and 3 other locations) |
| Trial ID | NCT04535843 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the clinical capacity for diagnosing and understanding the natural history of myasthenia gravis (MG) among Chinese patients. It plans to recruit 300 patients with MG, documenting their conditions and following them over time. The study will focus on the management of screening tests and the manifestations of the cohort, utilizing biomarkers and omics data for analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with myasthenia gravis who exhibit fluctuating muscle weakness and meet specific diagnostic criteria.
Not a fit: Patients with conditions that mimic or overlap with myasthenia gravis, such as Lambert-Eaton syndrome or congenital myasthenia syndrome, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better management strategies for patients with myasthenia gravis.
How similar studies have performed: While this approach is focused on a specific population, similar studies have shown promise in improving diagnostic accuracy and patient outcomes in other regions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality and 3 other locations
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Obsterics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Huashan Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Chongbo Zhao, MD
- Email: zhao_chongbo@fudan.edu.cn
- Phone: 86-021-52889999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.