- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05587114
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hyun Koo Kim, MD, PhD
- Phone Number: 82-2-2626-1185
- Email: kimhyunkoo@korea.ac.kr
Study Locations
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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
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Contact:
- Byeong Hyeon Choi, PhD
- Phone Number: 82-2-2626-1978
- Email: bhchoi1001@korea.ac.kr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Time Frame: 2020 ~ 2025
|
|
2020 ~ 2025
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Diagnostic analysis of lung cancer-specific exosome marker concentrations in a peripheral vein and primary lung cancer outflow pulmonary vein
Time Frame: 2020 ~ 2025
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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
Time Frame: 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)
|
2020 ~ 2025
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hyun Koo Kim, MD, PhD, Korea University Guro Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020GR0340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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