Comparision of Various Biomarkers Between Peripheral and Pulmonary Blood

A Retrospective Study to Compare Biomarker Expression of Exosomes Derived From Peripheral Blood and Primary Lung Cancer Drainage Pulmonary Blood in Lung Cancer Patients

Lung cancer is a leading cause of cancer death worldwide. Early diagnosis is linked to a better prognosis. Further, surgical resection at the early stages of non-small cell lung cancer (NSCLC) results in markedly improved survival rates. Computed tomography (CT)- or bronchoscopy-guided needle biopsies are standard definitive diagnostic procedures for lung cancer and are used to obtain tissue for pathological examination. However, these procedures are invasive, difficult to repeat, expensive, and risk exposure to radiation. Conversely, liquid biopsies, such as circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and extracellular vesicles (EVs), are simple and less invasive procedures that can be repeated more frequently than tissue biopsies.

This study is a retrospective blood sample obtained and prospectively comparative analysis of various biomarkers (cancer markers, and exosome markers) derived from peripheral blood and pulmonary venous blood from patients who underwent lung cancer surgery.

And treatment monitoring using biomarkers compare with peripheral and pulmonary blood.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Diagnosis
• Intervention / Treatment: Diagnostic test: frozen blood plasma samples

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Hyun Koo Kim, MD, PhD; Phone Number: 82-2-2626-1185; Email: kimhyunkoo@korea.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Seunghoe Song, MBE; Phone Number: 82-2-2626-1635; Email: ssessong@korea.ac.kr
    • Contact: Byeong Hyeon Choi, PhD; Phone Number: 82-2-2626-1978; Email: bhchoi1001@korea.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

For this study, Koreans, regardless of gender, were studied for adults over 40 years of age.

Blood plasma samples are optained from stored in the biobank of Korea University Guro Hospital or the Department of Thoracic and Cardiovascular Surgery of Korea University Guro Hospital

Description

Inclusion Criteria:

• Adults with Korean nationality
• Patients who did not receive neoadjuvant therapy before surgery
• Patients not diagnosed with any other cancer before surgery
• Patients who agreed to the consent form for a donation of human materials during surgery

Exclusion Criteria:

• Patients who do not meet the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative analysis of cancer marker concentrations in a peripheral vein and primary lung cancer outflow pulmonary vein	Comparative analysis of CEA and lung cancer-specific exosome marker concentrations in peripheral blood and pulmonary blood using ELISA assay; Characterization of exosomes using western blot, NTA, and TEM analysis	2020 ~ 2025
Diagnostic analysis of lung cancer-specific exosome marker concentrations in a peripheral vein and primary lung cancer outflow pulmonary vein	1) Evaluation of the clinical usefulness of lung cancer diagnosis using lung cancer-specific exosome markers in peripheral vein blood and primary lung cancer outflow pulmonary vein-derived blood.	2020 ~ 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of lung cancer treatment monitoring using lung cancer-specific exosome biomarkers	Clinical evaluation of recurrence or cancer metastasis after treatment in patients who underwent lung cancer surgery using lung cancer-specific exosome biomarkers according to blood sample location (peripheral vein blood and primary lung cancer outflow pulmonary vein derived blood)	2020 ~ 2025

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Investigators: Principal Investigator: Hyun Koo Kim, MD, PhD, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 13, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer; biomarker; prognosis; diagnosis; liquid biopsy; Exosome
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Disease
• Other Study ID Numbers: 2020GR0340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No