Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Myocarditis Due to Drug | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker Analysis for Severity Assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Severe/critical group
- description
- Severe Type: Significant symptoms (e.g., fatigue, palpitations, chest pain) triggered by daily activities without hemodynamic changes; elevated myocardial biomarkers (Cardiac troponin, creatine kinase, Creatine kinase myocardial band, Aspartate aminotransferase,natriuretic peptides); new ECG changes; structural and functional myocardial abnormalities on echocardiography or MRI. Critical Type: Intolerable symptoms (e.g., respiratory dysfunction, heart failure, cardiogenic shock) at rest or minimal activity, with hemodynamic instability; significantly elevated myocardial biomarkers (Cardiac troponin, creatine kinase, Creatine kinase myocardial band, Aspartate aminotransferase, natriuretic peptides); severe myocardial structural and functional abnormalities on echocardiography or MRI; new severe arrhythmias on ECG .
- interventionNames
- Diagnostic Test: Biomarker Analysis for Severity Assessment
- label
- Subclinical myocardial injury/mild group
- description
- Subclinical Myocardial Injury: All three of the following criteria must be met: 1. No clinical symptoms triggered by daily activities; 2. Only mild elevation of Cardiac troponin levels without elevation of other myocardial injury biomarkers; 3. No abnormalities detected in other auxiliary examinations. Mild Type: The following conditions must be met for diagnosis: 1. Daily activities may cause mild, nonspecific symptoms such as fatigue or shortness of breath; 2. Mild elevation of myocardial injury biomarkers (Cardiac troponin, creatine kinase, Creatine kinase myocardial band, Aspartate aminotransferase,natriuretic peptides); 3. Mild abnormalities on ECG, including new-onset sinus tachycardia, atrial arrhythmias, or nonspecific ST-T changes; 4. No structural or functional abnormalities of the myocardium detected by echocardiography or cardiac MRI.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnancy or breastfeeding; * Presence of 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.
References
Publications (0)
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