Actively Recruiting
Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer
Led by Shanghai Chest Hospital · Updated on 2025-02-10
50
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Pregnancy or breastfeeding
- Presence of severe underlying cardiovascular diseases or recent acute cardiac events such as myocardial infarction or severe arrhythmia
- Concurrent other malignancies, immunosuppressive diseases, or autoimmune diseases
- Inability to complete the required examinations and follow-ups specified in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yanbin Kuang, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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