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Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma Derived Exosome

Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04529915
Enrollment
470
Registered
2020-08-28
Start date
2020-04-09
Completion date
2023-12-29
Last updated
2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Blood plasma, Exosome, Liquid biopsy, Lung cancer, Biomarker, Deep-learning analysis

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.

Interventions

DIAGNOSTIC_TESTExosome sampling

* Centrifugation of blood plasma * Size exclusion chromatography * ELISA assay, Western blotting * Deep-learning analysis

Sponsors

Korea University Guro Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the distinction between healthy controls and lung cancer patients through deep-learning analysis of exosomes3 yearsComparative evaluation of whether it is possible to distinguish between healthy controls and lung cancer patients through deep-learning analysis of exosomes
Evaluating the possibility of distinguishing between normal and lung cancer patients through the analysis of lung cancer-specific exosomal protein3 yearsQuantitative analysis using lung cancer-specific exosomal protein evaluated the possibility of distinguishing between healthy controls and lung cancer patients.

Secondary

MeasureTime frameDescription
Evaluation of the possibility of distinguishing the early pathological stages in lung cancer patients through deep-learning analysis of exosomes3 yearsEvaluating whether the early stages of lung cancer patients can be distinguished using deep-learning analysis of exosomes
Evaluation of the possibility of distinguishing the early pathological stages in lung cancer patients through quantitative analysis of lung cancer specific exosomal proteins3 yearsEvaluating whether the early stages of lung cancer patients can be distinguished using quantitative analysis of lung cancer specific exosomal proteins

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026