Comparision of Various Biomarkers Between Peripheral and Pulmonary Blood

Recruiting

• Conditions: Lung Cancer; Diagnosis

• Registration Number: NCT05587114
• Lead Sponsor: Korea University Guro Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-13
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-16
• Last Update Submitted: 2022-10-16
• Study First Posted: 2022-10-19
• Last Update Posted: 2022-10-19
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

• Patients who do not meet the inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparative analysis of cancer marker concentrations in a peripheral vein and primary lung cancer outflow pulmonary vein	2020 ~ 2025	1. Comparative analysis of CEA and lung cancer-specific exosome marker concentrations in peripheral blood and pulmonary blood using ELISA assay; 2. 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

Name	Time	Method
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)

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of