Study of Biomarkers for Classifying and Predicting Outcomes of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients

What this Trial Is About

Researchers are studying the clinical classification and outcome-related biomarkers of myocarditis caused by immune checkpoint inhibitors ICIs in patients with lung cancer. This observational study will enroll 50 patients with ICI-related myocarditis, divided into two groups 25 with severe or critical myocarditis and 25 with subclinical or mild myocarditis. The goal is to develop a model that accurately assesses disease severity and predicts prognosis by combining various biomarkers and clinical data, improving clinical management. Participants will have blood samples collected at baseline and during follow-up at 3 days, 7 days, and before hospital discharge. These samples will be tested for traditional myocardial injury markers, iron metabolism-related markers, and immunological markers. Patients will be classified into groups based on symptom severity and biomarker levels, with severecritical patients showing significant symptoms and heart abnormalities, while subclinicalmild patients show limited or no symptoms and mild biomarker changes. During the study, researchers will collect clinical information such as in-hospital mortality, 3-month survival rates, symptom improvement, and length of hospital stay. The primary outcomes include the relationship between biomarker changes and disease severity and the performance of the severity assessment model over three months. Participants will undergo necessary examinations and follow-ups to monitor their condition and biomarker levels throughout the study period.

Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer