Liquid Biopsy Using Methylation Sequencing for Lung Cancer

Study Overview
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Brief Summary
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This study aims to investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer.

Detailed Description
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Plasma sample of patients with and without lung cancer will be collected and analyzed using methylation-sensitive enzyme sequencing method. Diagnostic performance of ctDNA methylation sequencing will be compared with that of tumor markers (CEA, Cyfra 21-1, and NSE) combined.

Official Title
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Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer

Conditions
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Lung Cancer, Diagnoses Disease

Intervention / Treatment
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* Diagnostic Test: Circulating Tumor DNA Methylation Sequencing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lung cancer group Pathologically proven lung cancer Clinically suspected lung cancer on chest CT scan Benign pulmonary disease group Chronic obstructive pulmonary disease, interstitial lung disease, pneumonia, bronchiectasis, non-tuberculous mycobacterial lung disease, pulmonary vascular disease Exclusion Criteria: Patients with previous history of lung cancer Patients who have been diagnosed with other malignancy within 5 years Unstable vital status Active pulmonary tuberculosis Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung cancer<br> | Diagnostic Test: Circulating Tumor DNA Methylation Sequencing<br>* Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.<br>|
| Benign pulmonary disease<br> | Diagnostic Test: Circulating Tumor DNA Methylation Sequencing<br>* Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic sensitivity of ctDNA methylation sequencing | Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of ctDNA methylation will be compared with that of tumor markers. | 2 year | 
| Diagnostic specificity of ctDNA methylation sequencing | Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of ctDNA methylation will be compared with that of tumor markers. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of ctDNA methylation sequencing | Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of ctDNA methylation will be compared with that of tumor markers. | 2 year | 
| Positive predictive value of ctDNA methylation sequencing | Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of ctDNA methylation will be compared with that of tumor markers. | 2 year | 
| Negative predictive value of ctDNA methylation sequencing | Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of ctDNA methylation will be compared with that of tumor markers. | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Methylation Sequencing, Liquid Biopsy