RecruitingNCT06818149

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

A Study on the Clinical Classification and Outcome-Related Biological Markers of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients

Sponsor

Shanghai Chest Hospital

Enrollment

50 participants

Start Date

Jan 30, 2025

Study Type

OBSERVATIONAL

Conditions

Lung Cancer Myocarditis Due to Drug

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at biological markers (biomarkers) in lung cancer patients who developed heart inflammation (myocarditis) as a side effect of immunotherapy drugs called immune checkpoint inhibitors. The goal is to better understand and classify this rare but serious complication. **You may be eligible if...** - You have been diagnosed with lung cancer (confirmed by a tissue biopsy) - You have received at least one dose of immune checkpoint inhibitor therapy - You have been diagnosed with heart inflammation (myocarditis) caused by that therapy - You are 18 years old or older **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have severe pre-existing heart disease or recently had a heart attack or dangerous irregular heartbeat - You have another active cancer, immune-suppressing condition, or autoimmune disease - You are unable to complete the required tests and follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBiomarker Analysis for Severity Assessment

Blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). Traditional myocardial injury biomarkers, iron metabolism-related biomarkers, and immunological biomarkers will be tested.