Liquid Biopsy Using Methylation Sequencing for Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253509
• Other study ID #: 2019-11-080
• Status: Completed
• Start date: February 3, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diagnoses Disease
• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• Circulating Tumor DNA Methylation Sequencing
Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	EDGC Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic sensitivity of ctDNA methylation sequencing	Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of ctDNA methylation will be compared with that of tumor markers.	2 year
Primary	Diagnostic specificity of ctDNA methylation sequencing	Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of ctDNA methylation will be compared with that of tumor markers.	2 year
Secondary	Diagnostic accuracy of ctDNA methylation sequencing	Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of ctDNA methylation will be compared with that of tumor markers.	2 year
Secondary	Positive predictive value of ctDNA methylation sequencing	Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of ctDNA methylation will be compared with that of tumor markers.	2 year
Secondary	Negative predictive value of ctDNA methylation sequencing	Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of ctDNA methylation will be compared with that of tumor markers.	2 year