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

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: Exosome sampling

• Registration Number: NCT04529915
• Lead Sponsor: 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-09
• Study First Submitted: 2020-08-02
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-30
• Primary Completion: 2023-12-29
• Study Completion: 2023-12-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 470

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

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Exclusion Criteria

• Patients who do not meet the inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung cancer	Exosome sampling	-
Healthy	Exosome sampling	-

Primary Outcome Measures

Name	Time	Method
Evaluating the possibility of distinguishing between normal and lung cancer patients through the analysis of lung cancer-specific exosomal protein	3 years	Quantitative analysis using lung cancer-specific exosomal protein evaluated the possibility of distinguishing between healthy controls and lung cancer patients.
Evaluation of the distinction between healthy controls and lung cancer patients through deep-learning analysis of exosomes	3 years	Comparative evaluation of whether it is possible to distinguish between healthy controls and lung cancer patients through deep-learning analysis of exosomes

Secondary Outcome Measures

Name	Time	Method
Evaluation of the possibility of distinguishing the early pathological stages in lung cancer patients through deep-learning analysis of exosomes	3 years	Evaluating 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 proteins	3 years	Evaluating whether the early stages of lung cancer patients can be distinguished using quantitative analysis of lung cancer specific exosomal proteins

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Guro-gu, Korea, Republic of