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

RECRUITINGSponsored by Shanghai Chest Hospital
Actively Recruiting
SponsorShanghai Chest Hospital
Started2025-01-30
Est. completion2025-02-01
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

CancerHeart DiseaseLung CancerMyocarditis Due to Drug

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