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

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ClinicalTrials.gov Identifier: NCT04529915
Recruitment Status : Active, not recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Hyun Koo Kim, 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 = 420) are obtained from the Human biobank of five hospitals participating in the study.


Condition or disease Intervention/treatment
Lung Cancer Diagnostic Test: Exosome sampling

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Study Type : Observational
Estimated Enrollment : 470 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma
Actual Study Start Date : April 9, 2020
Estimated Primary Completion Date : December 29, 2023
Estimated Study Completion Date : December 29, 2023

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Evaluation of the distinction between healthy controls and lung cancer patients through deep-learning analysis of exosomes [ Time Frame: 3 years ]
    Comparative evaluation of whether it is possible to distinguish between healthy controls and lung cancer patients through deep-learning analysis of exosomes

  2. Evaluating the possibility of distinguishing between normal and lung cancer patients through the analysis of lung cancer-specific exosomal protein [ Time Frame: 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 :
  1. Evaluation of the possibility of distinguishing the early pathological stages in lung cancer patients through deep-learning analysis of exosomes [ Time Frame: 3 years ]
    Evaluating whether the early stages of lung cancer patients can be distinguished using deep-learning analysis of exosomes

  2. Evaluation of the possibility of distinguishing the early pathological stages in lung cancer patients through quantitative analysis of lung cancer specific exosomal proteins [ Time Frame: 3 years ]
    Evaluating whether the early stages of lung cancer patients can be distinguished using quantitative analysis of lung cancer specific exosomal proteins


Biospecimen Retention:   Samples Without DNA
Blood plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  1. Patients with primary adenocarcinoma of lung with permanent pathology of N0
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529915


Locations
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Korea, Republic of
Korea University Guro Hospital
Seoul, Guro-gu, Korea, Republic of, 08308
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
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Principal Investigator: Hyun Koo MD, PhD, MD, PhD Professor
Publications:
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Responsible Party: Hyun Koo Kim, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT04529915    
Other Study ID Numbers: 2020GR0176
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hyun Koo Kim, Korea University Guro Hospital:
Blood plasma
Exosome
Liquid biopsy
Lung cancer
Biomarker
Deep-learning analysis
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases