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NCT Number: NCT03791034

Cell Free DNA for the Diagnosis and Treatment in Early NSCLC

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Disease Attributes Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recurrence

    Time frame: 24 months

    Recurrence of primary tumor documented by diagnostic imaging with or without biopsy

Study contacts

Contact information is provided by the study sponsor or research team.

Jhingook Kim, MD

CONTACT

[email protected]

+82-2-3410-3483

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Guardant Health, Inc.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2026
First posted
Jan 2, 2019
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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