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

NCT ID: NCT04529915

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

470 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-09

Study Completion Date

2023-12-29

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Keywords

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Lung cancer

Exosome sampling

Intervention Type DIAGNOSTIC_TEST

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

Healthy

Exosome sampling

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Exosome sampling

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients with primary adenocarcinoma of lung with permanent pathology of N0 or N1
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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyun Koo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun Koo MD, PhD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Korea University Guro Hospital

Seoul, Guro-gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 17145848 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 19308068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20610625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18066649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20567244 (View on PubMed)

Other Identifiers

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2020GR0176

Identifier Type: -

Identifier Source: org_study_id