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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05587114
Other study ID # 2020GR0340
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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