Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC

• Conditions: Lung Neoplasms

• Registration Number: NCT04922073
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-26
• Study Start: 2021-06-01
• Study First Submitted QC: 2021-06-06
• Study First Posted: 2021-06-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-27
• Primary Completion: 2022-01-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of