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RECRUITING
NCT06818149

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

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2025-01-30

Completion Date

2028-12-30

Last Updated

2025-02-10

Healthy Volunteers

No

Interventions

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, China