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Cell Free DNA for the Diagnosis and Treatment in Early NSCLC

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03791034
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : January 1, 2019
Guardant Health, Inc.
Information provided by (Responsible Party):
Jhingook Kim, Samsung Medical Center

Brief Summary:
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.

Condition or disease
Non-small Cell Lung Cancer

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Feasibility Study of Cell Free Circulating Tumor DNA for the Diagnosis and Treatment Monitoring in Early-stage Non-small Cell Lung Cancer
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Recurrence [ Time Frame: 24 months ]
    Recurrence of primary tumor documented by diagnostic imaging with or without biopsy

Biospecimen Retention:   Samples With DNA
We will collect peripheral blood cell-free tumor DNA serially in non-small cell lung cancer cancer patients.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
non-small cell lung cancer patients who undergone curative surgery

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

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 identifier (NCT number): NCT03791034

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Contact: Jhingook Kim, MD +82-2-3410-3483

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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Jhingook Kim, MD    +82-2-3410-3483   
Sponsors and Collaborators
Samsung Medical Center
Guardant Health, Inc.
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Study Chair: Jhingook Kim, MD Samsung Medical Center

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Responsible Party: Jhingook Kim, Professor, Samsung Medical Center Identifier: NCT03791034     History of Changes
Other Study ID Numbers: 2017-08-041-003
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jhingook Kim, Samsung Medical Center:
Non-small cell lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms