Clinical trial NCT06818149: Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer
Official title: A Study on the Clinical Classification and Outcome-Related Biological Markers of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Myocarditis Due to Drug
Keywords: Lung Cancer
Myocarditis
Immune Checkpoint Inhibitors
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The correlation between the dynamic changes in biomarker combinations and disease severity.
timeFrame: Up to 3 months
measure: Predictive performance of the severity assessment model
timeFrame: Up to 3 months
Secondary outcomes:
measure: In-hospital mortality
timeFrame: Up to 3 months
measure: 3-month survival rate
timeFrame: Up to 3 months
measure: Improvement in patients' symptoms.
timeFrame: Up to 3 months
measure: Length of hospital stay.
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: