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

NCT04529915 | Unknown

• 1 other identifier: 2020GR0176
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Evaluation of the distinction between healthy controls and lung cancer patients through deep-learning analysis of exosomes

  Comparative evaluation of whether it is possible to distinguish between healthy controls and lung cancer patients through deep-learning analysis of exosomes

  3 years

• Evaluating the possibility of distinguishing between normal and lung cancer patients through the analysis of lung cancer-specific exosomal protein

  Quantitative analysis using lung cancer-specific exosomal protein evaluated the possibility of distinguishing between healthy controls and lung cancer patients.

  3 years

Secondary Outcomes (2)

• Evaluation of the possibility of distinguishing the early pathological stages in lung cancer patients through deep-learning analysis of exosomes

  3 years

• 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

Study Arms (2)

Lung cancer

Diagnostic Test: Exosome sampling

Healthy

Diagnostic Test: Exosome sampling

Interventions

Exosome sampling DIAGNOSTIC_TEST

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

Healthy; Lung cancer

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

Location

Related Publications (5)

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  PMID: 17145848 BACKGROUND

• Psaila B, Lyden D. The metastatic niche: adapting the foreign soil. Nat Rev Cancer. 2009 Apr;9(4):285-93. doi: 10.1038/nrc2621.

  PMID: 19308068 BACKGROUND

• 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.

  PMID: 20610625 BACKGROUND

• 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. doi: 10.1007/s10555-007-9103-x.

  PMID: 18066649 BACKGROUND

• 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.

  PMID: 20567244 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hyun Koo MD, PhD, MD, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 28, 2020
• Study Start: April 9, 2020
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

KR (1)