Investigating biomarkers for myocarditis in lung cancer patients treated with immune checkpoint inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify clinical classification and outcome-related biomarkers for immune checkpoint inhibitor (ICI)-related myocarditis in lung cancer patients. It will enroll 50 patients, dividing them into two groups based on the severity of myocarditis: severe/critical and subclinical/mild. Blood samples will be collected at various time points to measure traditional myocardial injury markers, iron metabolism-related markers, and immunological markers. The study will also assess changes in these biomarkers post-treatment and integrate clinical information to develop a severity assessment model for better prognostic evaluation.

Why it matters

Who can join: the full rules

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's running

• Shanghai Chest Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yanbin Kuang, PhD
• Email: kybkyb2@163.com
• Phone: +86 021-22200000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.