Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer
Recruiting · NCT06818149 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shanghai Chest Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study aims to investigate the clinical classification and outcome-related biomarkers of immune checkpoint inhibitor (ICI)-related myocarditis in patients with lung cancer.A total of 50 patients with ICI-related myocarditis will be enrolled, including 25 with severe/critical myocarditis and 25 with subclinical/mild myocarditis. Blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). Traditional myocardial injury markers, iron metabolism-related markers, and immunological markers will be measured and compared between groups. Changes in biomarkers after treatment will also be assessed. Clinical information such as in-hospital mortality and 3-month survival rates will be integrated to develop a severity assessment model. This model aims to evaluate disease severity and prognostic risk accurately by combining biomarkers, enhancing their application in clinical management.
Who can take part
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 it is running
1 location listed.
- Shanghai Chest Hospital - Shanghai, China