Cell Free DNA for the Diagnosis and Treatment in Early NSCLC

NCT ID: NCT03791034

Last Updated: 2021-05-11

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

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-28

Study Completion Date

2026-12-31

Brief Summary

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The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA (cfDNA) can aid screening of recurrence after complete resection of early stage non-small cell lung cancer.

Detailed Description

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During evolution of primary tumor, tumor cells can be released into the bloodstream. It has also been shown that circulating cell-free tumor DNA (cfDNA) is released from apoptotic or necrotic tumor cells. In a study of cfDNA level after surgery in colon cancer patients, they suggested that cfDNA could detect recurrence of cancer several months earlier than the conventional follow up studies. Following several reports have suggested that cfDNA can invade host cells and alter host cell biology to cause cancer metastasis.

In this regard, we will collect from non-small cell lung cancer patients cohort who underwent curative resection, and will evaluate whether peripheral cfDNA can aid early detection of cancer recurrence. We will also study the genomic signature of cfDNA to assess the relationship between cfDNA and clinical outcome of non-small cell lung cancer patients.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All subjects need to sign the informed consent form
* All subjects have Non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively.
* Non-small cell lung cancer have to confirmed pathologically after operation
* Clinical stage I - IIIA by AJCC 7th staging system

Exclusion Criteria

* Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
* Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix with 3 years before enrollment
* Recurrent lung cancer
* Stage IIIB, IV by AJCC 7th staging system
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guardant Health, Inc.

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jhingook Kim, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jhingook Kim, MD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jhingook Kim, MD

Role: CONTACT

+82-2-3410-3483

Facility Contacts

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Jhingook Kim, MD

Role: primary

+82-2-3410-3483

Other Identifiers

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2017-08-041-003

Identifier Type: -

Identifier Source: org_study_id

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