- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04529915
Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma Derived Exosome
Multicenter Clinical Research for Early Diagnosis of Lung Cancer Using Blood Plasma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Guro-gu
-
Seoul, Guro-gu, Korea, Republic of, 08308
- Korea University Guro Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lung cancer
|
|
Healthy
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 years
|
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hyun Koo MD, PhD, MD, PhD, Professor
Publications and helpful links
General Publications
- Psaila B, Lyden D. The metastatic niche: adapting the foreign soil. Nat Rev Cancer. 2009 Apr;9(4):285-93. doi: 10.1038/nrc2621.
- Kaplan RN, Rafii S, Lyden D. Preparing the "soil": the premetastatic niche. Cancer Res. 2006 Dec 1;66(23):11089-93. doi: 10.1158/0008-5472.CAN-06-2407.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020GR0176
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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