Lung Cancer Clinical Trial
Official title:
Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer
Verified date | February 2022 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer.
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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center | EDGC Inc. |
Korea, Republic of,
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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