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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 2, 2020
First Posted Date August 28, 2020
Last Update Posted Date August 28, 2020
Actual Study Start Date April 9, 2020
Estimated Primary Completion Date December 29, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2020)
  • 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
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 24, 2020)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma Derived Exosome
Official Title Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood plasma
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.

Condition Lung Cancer
Intervention Diagnostic Test: Exosome sampling
  • Centrifugation of blood plasma
  • Size exclusion chromatography
  • ELISA assay, Western blotting
  • Deep-learning analysis
Study Groups/Cohorts
  • Lung cancer
    Intervention: Diagnostic Test: Exosome sampling
  • Healthy
    Intervention: Diagnostic Test: Exosome sampling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 24, 2020)
470
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 29, 2023
Estimated Primary Completion Date December 29, 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT04529915
Other Study ID Numbers 2020GR0176
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Hyun Koo Kim, Korea University Guro Hospital
Study Sponsor Korea University Guro Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Hyun Koo MD, PhD, MD, PhD Professor
PRS Account Korea University Guro Hospital
Verification Date August 2020