Liquid Biopsy Using Methylation Sequencing for Lung Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04253509

Enrollment

280

Registered

2020-02-05

Start date

2020-02-03

Completion date

2022-01-31

Last updated

2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnoses Disease, Lung Cancer

Keywords

Lung Cancer, Methylation Sequencing, Liquid Biopsy

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.

Interventions

DIAGNOSTIC_TESTCirculating Tumor DNA Methylation Sequencing

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to 85 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026