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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Myocarditis Due to Drug; Lung Cancer

Treatments: Diagnostic Test: Biomarker Analysis for Severity Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT06818149

IS24178

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

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 .

Treatment:

Diagnostic Test: Biomarker Analysis for Severity Assessment

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.

Treatment:

Diagnostic Test: Biomarker Analysis for Severity Assessment