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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Biomarker Analysis for Severity Assessment

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators