Actively Recruiting
Clinical Classification and Outcome Biomarkers of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients
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
Researchers are studying the clinical classification and outcome-related biomarkers of myocarditis caused by immune checkpoint inhibitors (ICIs) in patients with lung cancer. This observational study will enroll 50 patients with ICI-related myocarditis, divided into two groups: 25 with severe or critical myocarditis and 25 with subclinical or mild myocarditis. The goal is to develop a model that accurately assesses disease severity and predicts prognosis by combining various biomarkers and clinical data, improving clinical management. Participants will have blood samples collected at baseline and during follow-up at 3 days, 7 days, and before hospital discharge. These samples will be tested for traditional myocardial injury markers, iron metabolism-related markers, and immunological markers. Patients will be classified into groups based on symptom severity and biomarker levels, with severe/critical patients showing significant symptoms and heart abnormalities, while subclinical/mild patients show limited or no symptoms and mild biomarker changes. During the study, researchers will collect clinical information such as in-hospital mortality, 3-month survival rates, symptom improvement, and length of hospital stay. The primary outcomes include the relationship between biomarker changes and disease severity and the performance of the severity assessment model over three months. Participants will undergo necessary examinations and follow-ups to monitor their condition and biomarker levels throughout the study period.
CONDITIONS
Brief 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 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
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 months
Participants undergo blood sample collection to test traditional myocardial injury biomarkers, iron metabolism-related biomarkers, and immunological biomarkers at baseline and follow-up time points.
1 baseline visit and 3 follow-up visits (at 3 days, 7 days, and before discharge)
Duration - Up to 3 months
Participants are observed for clinical outcomes including symptom improvement, in-hospital mortality, survival rate, and length of hospital stay up to 3 months.
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yanbin Kuang, PhD
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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