Investigating biomarkers for myocarditis in lung cancer patients treated with immune checkpoint inhibitors
A Study on the Clinical Classification and Outcome-Related Biological Markers of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients
This study is trying to find specific blood markers that can help doctors understand and predict heart problems in lung cancer patients who are being treated with immune therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Chest Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06818149 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify clinical classification and outcome-related biomarkers for immune checkpoint inhibitor (ICI)-related myocarditis in lung cancer patients. It will enroll 50 patients, dividing them into two groups based on the severity of myocarditis: severe/critical and subclinical/mild. Blood samples will be collected at various time points to measure traditional myocardial injury markers, iron metabolism-related markers, and immunological markers. The study will also assess changes in these biomarkers post-treatment and integrate clinical information to develop a severity assessment model for better prognostic evaluation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed lung cancer who have received immune checkpoint inhibitor therapy and are clinically diagnosed with ICI-related myocarditis.
Not a fit: Patients who are pregnant, breastfeeding, or have severe underlying cardiovascular diseases or recent acute cardiac events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the clinical management of lung cancer patients experiencing myocarditis by providing a reliable severity assessment model.
How similar studies have performed: While this approach is focused on a specific condition, similar studies investigating biomarkers in cancer treatments have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed lung cancer and having received at least one dose of immune checkpoint inhibitor therapy; * Clinically diagnosed with immune checkpoint inhibitor-related myocarditis; * Aged 18 years or older; * Voluntarily signed informed consent after being fully informed. Exclusion Criteria: * Pregnancy or breastfeeding; * Presence of severe underlying cardiovascular diseases or recent acute cardiac events (e.g., myocardial infarction, severe arrhythmia); * Concurrent other malignancies, immunosuppressive diseases, or autoimmune diseases; * Inability to complete the required examinations and follow-ups specified in the study.
Where this trial is running
Shanghai
- Shanghai Chest Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yanbin Kuang, PhD
- Email: kybkyb2@163.com
- Phone: +86 021-22200000
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.