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

Korea University

Status

Unknown

Conditions

Lung Cancer

Treatments

Diagnostic Test: Exosome sampling

Study type

Observational

Funder types

Other

Identifiers

NCT04529915

2020GR0176

Details and patient eligibility

About

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.

Enrollment

470 estimated patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria