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Completed

NCT Number: NCT04253509

Liquid Biopsy Using Methylation Sequencing for Lung Cancer

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

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Key information

Conditions

Lung Cancer Diagnoses Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Circulating Tumor DNA Methylation Sequencing

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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

  1. Diagnostic accuracy of ctDNA methylation sequencing

    Time frame: 2 year

    Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of ctDNA methylation will be compared with that of tumor markers.

  2. Positive predictive value of ctDNA methylation sequencing

    Time frame: 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.

  3. Negative predictive value of ctDNA methylation sequencing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • EDGC Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2020
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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