Lung CancerNCT06818149
Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer
An observational study of Lung Cancer and Myocarditis Due to Drug, run by Shanghai Chest Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Myocarditis Due to Drug
- What is being tested?
- Biomarker Analysis for Severity Assessment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2025to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai
Yanbin Kuang, PhD, +86 021-22200000, kybkyb2@163.com
About this study
Official title: A Study on the Clinical Classification and Outcome-Related Biological Markers of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients
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
- Being tested
- Biomarker Analysis for Severity Assessment
- Keywords
- Lung Cancer, Myocarditis, Immune Checkpoint Inhibitors
- Medical subject headings
- Lung Neoplasms, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker Analysis for Severity AssessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Diagnostic Test: Biomarker Analysis for Severity Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 months
Secondary outcomes (4)
In-hospital mortality
The rate of death occurring within the hospital during a patient's stay.
Measured: Up to 3 months
3-month survival rate
The 3-month survival rate will be defined as the proportion of patients alive 3 months after enrollment in the study.
Measured: Up to 3 months
Improvement in patients' symptoms.
Patients' symptom improvement (e.g., fatigue, dyspnea) will be recorded using the New York Heart Association (NYHA) Functional Classification and analyzed in relation to changes in biomarker combinations. This will provide insights into the potential application of biomarkers in predicting symptom improvement and disease severity.
Measured: Up to 3 months
Length of hospital stay.
The length of hospital stay will be recorded and analyzed in relation to biomarker combinations and model prediction results, providing additional data to support practical applications in clinical management.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start30 Jan 2025 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbin Kuang, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818149
- Sponsor's protocol ID
- IS24178
- Status last verified
- Feb 2025
- First submitted
- 9 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Clinical Classification and Outcome-Related Biological Markers of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06818149
- Acronym / sponsor ID
- IS24178
- Conditions
- Lung Cancer, Myocarditis Due to Drug
- Keywords
- Lung Cancer, Myocarditis, Immune Checkpoint Inhibitors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe/critical group | – | Diagnostic Test: Biomarker Analysis for Severity AssessmentSevere 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 . |
| Subclinical myocardial injury/mild group | – | Diagnostic Test: Biomarker Analysis for Severity AssessmentSubclinical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker Analysis for Severity AssessmentBlood 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. | Diagnostic test | Severe/critical group, Subclinical myocardial injury/mild group |
Primary outcome
The correlation between the dynamic changes in biomarker combinations and disease severity.
Time frame: Up to 3 months
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.
Predictive performance of the severity assessment model
Time frame: Up to 3 months
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Myocarditis Due to Drug, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanbin Kuang, PhD (+86 021-22200000, kybkyb2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between the dynamic changes in biomarker combinations and disease severity. (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.