Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC

Overview

The aim of the study is to assess the practical usability of EGFR mutation detection in ctDNA from early NSCLC.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 31, 2022

Clinical Trial Outcome Measures

Primary Measures

  • Performance of the EGFR assay
    • Time Frame: Immediately before the surgery
    • ADPS EGFR Mutation Test using plasma sample from clinical stage IB-IIIA NSCLC patients (reference: EGFR assay in tissue specimen)

Participating in This Clinical Trial

Inclusion Criteria

  • Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer – Patients with resectable lung cancer – One of followings: 1) Never-smokers or ex-smokers who quit 10 years ago, 2) Female 3) Subsolid nodule in chest CT 4) Biopsy-proven adenocarcinoma Exclusion Criteria:

  • Patients with metastatic lung cancer (Stage IIIB-IV) – Patients who underwent chemotherapy or radiotherapy – Patients with other malignancies

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 85 Years

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Collaborator
    • GeneCast Biotechnology Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jhingook Kim, MD, Professor – Samsung Medical Center

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