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Establishment and verification of a precise immune molecular evaluation model for thymectomy for the treatment of myasthenia gravis: a nested case-control study

Establishment and verification of a precise immune molecular evaluation model for thymectomy for the treatment of myasthenia gravis: a nested case-control study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050890
Enrollment
Unknown
Registered
2021-09-07
Start date
2021-09-10
Completion date
Unknown
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia gravis

Interventions

Drug group:No

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who have been diagnosed with myasthenia gravis (MG) (type II-IV) according to the 2015 Myasthenia Gravis Diagnosis and Treatment Guidelines as assessed by cardiothoracic surgeons or neurologists of our center; 2. The onset time of MG in the patient is less than 5 years; 3. Aged 18-65 years; 4. Serum acetylcholine receptor antibody (AchR) is positive; 5. Abnormal repetitive nerve stimulation or abnormal single fiber EMG; 6. Thymus imaging (CT or MR) clearly shows thymic area occupation; 7. Received treatment at the research center from January 2010 to December 2021; 8. Subjects voluntarily joining the study, agree to collect relevant information including thymus pathology information, and sign an informed consent file (patients under the age of 18 are signed by their legal representatives).

Exclusion criteria

Exclusion criteria: 1. Accompanied by serious basic diseases, such as liver and kidney failure, heart failure, etc.; 2. Patients with other tumors; 3. Mental illness affects the prognosis assessment; 4. Postoperative pathology shows thymoma or a patient who has undergone thymectomy, or a patient who has not receive minimally invasive endoscopic surgery this time; 5. Patients who have received immunosuppressive therapy other than prednisone and other hormones; 6. Patients who are pregnant or breastfeeding or who are unwilling to avoid pregnancy; 7. Patients with clear contraindications to glucocorticoids; 8. According to the judgment of the investigator, patients are struggling with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 9. The investigator assesses those who are expected to have poor compliance.

Design outcomes

Primary

MeasureTime frame
Onset time;Neostigmine test results;Repetitive frequency electrical stimulation results;AChR-Ab;Musk-Ab;Flow cytometry results of peripheral blood immune cell subsets;Immunocytokine;Thymus imaging examination results (CT/MR);Quantitative Myasthenia Gravis score;MG(Myasthenia gravis)-Activies of Daily Living score;MGFA(Myasthenia Gravis Foundation of America) Classification;Thyroid function test results;Total length of hospitalization;Overall hospitalization costs;Hormone usage;Time of ventilator after operation;Postoperative pathological results;Immunofluorescence Analysis of Immune Cell Subgroups in Postoperative Tissue Sections;

Countries

China

Contacts

Public ContactZhang Peng

Tianjin Medical University General Hospital

zhang_peng1225@sina.com+86 13920467283

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026