Clinical trial NCT04529915: Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma Derived Exosome
Official title: Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Blood plasma
Exosome
Liquid biopsy
Lung cancer
Biomarker
Deep-learning analysis
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 470
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For this study, Koreans, regardless of gender, were studied for adults over 40 years of age.

Participating institutions for this clinical research are Korea University Guro Hospital, Gangnam Severance Hospital, Bundang Seoul National University Hospital, Seoul Asan Hospital, and Samsung Seoul Hospital.

Blood plasma samples is taken from stored in the biobank of each 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.

To analyze the exosomes abundantly present in the blood and to conduct clinical studies to determine whether it is possible to diagnose lung cancer. To this end, blood samples from normal people (n = 150) and lung cancer patients (n = 320) are obtained from the Human biobank of five hospitals participating in the study.


Eligibility criteria: Inclusion Criteria:

1. Patients with primary adenocarcinoma of lung with permanent pathology of N0 or N1
2. Patients with T1mi, Tsi, T1a, T1b, T1c, T2a, and T2b stage
3. An adult of Korean nationality
4. Patients without prior chemo/radiation treatment prior to lung cancer surgery
5. Patients who have not been diagnosed with other cancers prior to lung cancer surgery

Exclusion Criteria:

* Patients who do not meet the inclusion criteria

Primary outcomes:
measure: Evaluation of the distinction between healthy controls and lung cancer patients through deep-learning analysis of exosomes
timeFrame: 3 years
measure: Evaluating the possibility of distinguishing between normal and lung cancer patients through the analysis of lung cancer-specific exosomal protein
timeFrame: 3 years
Secondary outcomes:
measure: Evaluation of the possibility of distinguishing the early pathological stages in lung cancer patients through deep-learning analysis of exosomes
timeFrame: 3 years
measure: Evaluation of the possibility of distinguishing the early pathological stages in lung cancer patients through quantitative analysis of lung cancer specific exosomal proteins
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
Study officials:
affiliation: Professor
name: Hyun Koo MD, PhD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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