Liquid Biopsy Using Methylation Sequencing for Lung Cancer

Samsung Medical Center280 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

280

Conditions

Lung Cancer Diagnoses Disease

Interventions

Circulating Tumor DNA Methylation SequencingDIAGNOSTIC_TEST

Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Lung cancer group 1. Pathologically proven lung cancer 2. 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)

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2 year

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2 year

Data from ClinicalTrials.gov

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