Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biomarker Analysis for Severity Assessment.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Myocarditis Due to Drug. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study on the Clinical Classification and Outcome-Related Biological Markers of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients
Overview
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.
Interventions
- Diagnostic test Biomarker Analysis for Severity Assessment
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.
Primary outcome measures
- The correlation between the dynamic changes in biomarker combinations and disease severity. [Time frame: Up to 3 months]
- Predictive performance of the severity assessment model [Time frame: Up to 3 months]
Secondary outcome measures (4)
- In-hospital mortality [Time frame: Up to 3 months]
- 3-month survival rate [Time frame: Up to 3 months]
- Improvement in patients' symptoms. [Time frame: Up to 3 months]
- Length of hospital stay. [Time frame: Up to 3 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT06818149 · IS24178