Liquid Biopsy Using Methylation Sequencing for Lung Cancer

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04253509
• Collaborator: EDGC Inc. (Other)
• Enrollment: 280
• Location: 1
• Actual Duration (Months): 23.9
• Patients Per Site Per Month: 11.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Diagnoses Disease	Diagnostic Test: Circulating Tumor DNA Methylation Sequencing

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 280 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer
• Actual Study Start Date: Feb 3, 2020
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Lung cancer	Diagnostic Test: Circulating Tumor DNA Methylation Sequencing; Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.
Benign pulmonary disease	Diagnostic Test: Circulating Tumor DNA Methylation Sequencing; Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center
• EDGC Inc.

Investigators

• Principal Investigator: Sang-Won Um, MD, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sang-Won Um, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT04253509
• Other Study ID Numbers: 2019-11-080
• First Posted: Feb 5, 2020
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sang-Won Um, Professor, Samsung Medical Center: Lung Cancer; Methylation Sequencing; Liquid Biopsy
• Additional relevant MeSH terms: Lung Neoplasms; Disease

Study Results

No Results Posted as of Feb 8, 2022