Comparision of Various Biomarkers Between Peripheral and Pulmonary Blood

Sponsor

Korea University Guro Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05587114

Collaborator

(none)

150

Enrollment

Location

38.6

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Diagnosis	Diagnostic Test: frozen blood plasma samples

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Oct 13, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

Comparative analysis of cancer marker concentrations in a peripheral vein and primary lung cancer outflow pulmonary vein [2020 ~ 2025]
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
Diagnostic analysis of lung cancer-specific exosome marker concentrations in a peripheral vein and primary lung cancer outflow pulmonary vein [2020 ~ 2025]
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.

Secondary Outcome Measures

Evaluation of lung cancer treatment monitoring using lung cancer-specific exosome biomarkers [2020 ~ 2025]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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