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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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.

Study details
    Lung Cancer
    Myocarditis Due to Drug

NCT06818149

Shanghai Chest Hospital

5 September 2025

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