Liquid Biopsy in Lung Cancer

Completed

• Conditions: Circulating Tumor Cell; Lung Cancer (Diagnosis)

• Registration Number: NCT03479099
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to assess clinical utility of combined circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) in the diagnosis of primary lung cancer.

Detailed Description

The peripheral blood and tumor tissue samples are collected from the participants.CTC and ctDNA are analyzed from the blood samples.

Study Timeline

• Study Start: 2018-03-12
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-18
• Study First Posted: 2018-03-27
• Primary Completion: 2019-03-11
• Study Completion: 2019-03-11
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-24
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Patients with histology-proven lung cancer or a clinical suspicion of lung cancer
• Age >=18, < 80 years
• No previous history of cancer treatment within 5 years
• Patients who agree to participate

Exclusion Criteria

• Patients who have been diagnosed with malignancy within 5 years
• Patients with previous history of lung cancer
• Patients who have uncontrolled coagulopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic sensitivity of combined CTC and ctDNA	1 year	To compared the sensitivity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy of combined CTC and ctDNA	1 year	To compared the accuracy of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer
Diagnostic specificity of CTC and ctDNA	1 year	To compared the specificity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of