Cell Free DNA for the Diagnosis and Treatment in Early NSCLC

May 9, 2021 updated by: Jhingook Kim, MD, Samsung Medical Center

Prospective Feasibility Study of Cell Free Circulating Tumor DNA for the Diagnosis and Treatment Monitoring in Early-stage Non-small Cell Lung Cancer

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

non-small cell lung cancer patients who undergone curative surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 24 months
Recurrence of primary tumor documented by diagnostic imaging with or without biopsy
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Guardant Health, Inc.

Investigators

  • Study Chair: Jhingook Kim, MD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2017

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

December 29, 2018

First Submitted That Met QC Criteria

December 29, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 9, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-08-041-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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