Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Diagnostic sensitivity of ctDNA methylation sequencing
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study aims to investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer.
Detailed Description
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.
Investigators
Sang-Won Um
Professor
Samsung Medical Center
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Diagnostic sensitivity of ctDNA methylation sequencing
Time Frame: 2 year
Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of ctDNA methylation will be compared with that of tumor markers.
Diagnostic specificity of ctDNA methylation sequencing
Time Frame: 2 year
Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of ctDNA methylation will be compared with that of tumor markers.
Secondary Outcomes
- Negative predictive value of ctDNA methylation sequencing(2 year)
- Positive predictive value of ctDNA methylation sequencing(2 year)
- Diagnostic accuracy of ctDNA methylation sequencing(2 year)