Liquid Biopsy Using Methylation Sequencing for Lung Cancer

Samsung Medical Center

Status: Completed

Conditions: Lung Cancer; Diagnoses Disease

Treatments: Diagnostic Test: Circulating Tumor DNA Methylation Sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT04253509

2019-11-080

Details and patient eligibility

About

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

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

280 participants in 2 patient groups

Lung cancer

Treatment:

Diagnostic Test: Circulating Tumor DNA Methylation Sequencing

Benign pulmonary disease

Treatment:

Diagnostic Test: Circulating Tumor DNA Methylation Sequencing