Liquid Biopsy Using Methylation Sequencing for Lung Cancer

Completed

• Conditions: Lung Cancer; Diagnoses Disease
• Interventions: Diagnostic Test: Circulating Tumor DNA Methylation Sequencing

• Registration Number: NCT04253509
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Study Start: 2020-02-03
• Study First Posted: 2020-02-05
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-05
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung cancer	Circulating Tumor DNA Methylation Sequencing	-
Benign pulmonary disease	Circulating Tumor DNA Methylation Sequencing	-

Primary Outcome Measures

Name	Time	Method
Diagnostic sensitivity of ctDNA methylation sequencing	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of