Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma Derived Exosome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Lung cancer
|
Diagnostic Test: Exosome sampling
Centrifugation of blood plasma
Size exclusion chromatography
ELISA assay, Western blotting
Deep-learning analysis
|
| Healthy
|
Diagnostic Test: Exosome sampling
Centrifugation of blood plasma
Size exclusion chromatography
ELISA assay, Western blotting
Deep-learning analysis
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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:
- Patients who do not meet the inclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Guro Hospital | Seoul | Guro-gu | Korea, Republic of | 08308 |
Sponsors and Collaborators
- Korea University Guro Hospital
Investigators
- Principal Investigator: Hyun Koo MD, PhD, MD, PhD, Professor
Study Documents (Full-Text)
None provided.More Information
Publications
- Bidard FC, Pierga JY, Vincent-Salomon A, Poupon MF. A "class action" against the microenvironment: do cancer cells cooperate in metastasis? Cancer Metastasis Rev. 2008 Mar;27(1):5-10. Review.
- Kaplan RN, Rafii S, Lyden D. Preparing the "soil": the premetastatic niche. Cancer Res. 2006 Dec 1;66(23):11089-93. Review.
- Psaila B, Lyden D. The metastatic niche: adapting the foreign soil. Nat Rev Cancer. 2009 Apr;9(4):285-93. doi: 10.1038/nrc2621. Review.
- Talmadge JE, Fidler IJ. AACR centennial series: the biology of cancer metastasis: historical perspective. Cancer Res. 2010 Jul 15;70(14):5649-69. doi: 10.1158/0008-5472.CAN-10-1040. Epub 2010 Jul 7. Review.
- van Akkooi AC, Verhoef C, Eggermont AM. Importance of tumor load in the sentinel node in melanoma: clinical dilemmas. Nat Rev Clin Oncol. 2010 Aug;7(8):446-54. doi: 10.1038/nrclinonc.2010.100. Epub 2010 Jun 22. Review.
- 2020GR0176