Liquid Biopsy in Lung Cancer

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.

Completed

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Key information

Conditions

Lung Cancer (Diagnosis) Circulating Tumor Cell Disease Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 06278, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Diagnostic sensitivity of combined CTC and ctDNA

Time frame: 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 outcomes

Diagnostic accuracy of combined CTC and ctDNA

Time frame: 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

Time frame: 1 year

To compared the specificity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Clinical Utility of Combined CTC and ctDNA Assay in the Diagnosis of Primary Lung Cancer

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Mar 27, 2018
Registry last updated: Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed