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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04253509
Other study ID # 2019-11-080
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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