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

NCT06818149 | Recruiting

• 1 other identifier: IS24178
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Myocarditis Due to Drug

Keywords

Lung Cancer; Myocarditis; Immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (2)

• The correlation between the dynamic changes in biomarker combinations and disease severity.

  By monitoring the dynamic changes in biomarker combinations at different time points (baseline, day 3, day 7, and before discharge), this study aims to evaluate the differences between the severe/critical group and the mild/subclinical myocardial injury group, and investigate their correlation with disease severity. Independent sample t-tests will be used to assess the differences between the two groups, assuming a moderate effect size (Cohen's d = 0.7) for biomarkers between the severe/critical and subclinical/mild immune checkpoint inhibitor-related myocarditis patients. If significant differences (p \< 0.10) in biomarkers are observed between the groups, these differences will serve as key indicators for stratified management of disease severity.

  Up to 3 months

• Predictive performance of the severity assessment model

  The severity assessment model, constructed based on biomarker combinations, was evaluated for its predictive performance using indicators such as the ROC curve and AUC value. The model demonstrated a predictive performance with an AUC \> 0.75 at different time points, indicating a high predictive ability and validating its practical application in clinical risk stratification.

  Up to 3 months

Secondary Outcomes (4)

• In-hospital mortality

  Up to 3 months

• 3-month survival rate

  Up to 3 months

• Improvement in patients' symptoms.

  Up to 3 months

• Length of hospital stay.

  Up to 3 months

Study Arms (2)

Severe/critical group

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 .

Diagnostic Test: Biomarker Analysis for Severity Assessment

Subclinical myocardial injury/mild group

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.

Diagnostic Test: Biomarker Analysis for Severity Assessment

Interventions

Biomarker Analysis for Severity Assessment DIAGNOSTIC_TEST

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.

Severe/critical group; Subclinical myocardial injury/mild group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with pathologically confirmed lung cancer who have received at least one dose of immune checkpoint inhibitor (ICI) therapy and have been clinically diagnosed with ICI-related myocarditis. Eligible participants must be 18 years or older and capable of providing informed consent. Patients will be stratified into two groups based on disease severity: severe/critical myocarditis and mild/subclinical myocardial injury. Exclusion criteria include pregnancy or breastfeeding, severe underlying cardiovascular diseases or recent acute cardiac events, concurrent other malignancies or immune-related diseases, and inability to complete required examinations and follow-ups. This population is intended to represent a clinically relevant cohort for exploring the association between biomarker dynamics and disease severity in ICI-related myocarditis.

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Myocarditis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Yanbin Kuang, PhD

CONTACT

+86 021-22200000; kybkyb2@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician,PhD

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 10, 2025
• Study Start: January 30, 2025
• Primary Completion: February 1, 2025
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CN (1)