Comparision of Various Biomarkers Between Peripheral and Pulmonary Blood

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587114
• Other study ID #: 2020GR0340
• Status: Recruiting
• Start date: October 13, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Korea University Guro Hospital
• Contact: Hyun Koo Kim, MD, PhD
• Phone: 82-2-2626-1185
• Email: kimhyunkoo[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnosis
• Disease
• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• frozen blood plasma samples
Analysis of various biomarkers using frozen blood samples

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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