NCT06818149

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not 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.

Conditions

• Lung Cancer
• Myocarditis Due to Drug

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biomarker 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.

Timeline

• Start date: 2025-01-30
• Primary completion: 2025-02-01
• Completion: 2028-12-30
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: China