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

Recruitingn/aAges 18 Years - anyAllShanghai Chest Hospital
NCT06818149 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Biomarker Analysis for Severity Assessment
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Where

1 site
Shanghai Chest Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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