Clinical trial NCT05587114: Comparision of Various Biomarkers Between Peripheral and Pulmonary Blood
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Diagnosis
Keywords: Exosome
biomarker
lung cancer
diagnosis
prognosis
liquid biopsy
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparative analysis of cancer marker concentrations in a peripheral vein and primary lung cancer outflow pulmonary vein
timeFrame: 2020 ~ 2025
measure: Diagnostic analysis of lung cancer-specific exosome marker concentrations in a peripheral vein and primary lung cancer outflow pulmonary vein
timeFrame: 2020 ~ 2025
Secondary outcomes:
measure: Evaluation of lung cancer treatment monitoring using lung cancer-specific exosome biomarkers
timeFrame: 2020 ~ 2025
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Hyun Koo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: