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NCT04922073 Clinical Trial

Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC

Lung Neoplasms Clinical Trial

Official title:
Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04922073
Other study ID # 2021-04-150
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date March 31, 2022

Study information
Verified date August 2021
Source Samsung Medical Center
Contact Jhingook Kim, MD
Phone 82-2-3410-1696
Email jhingookkim@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date March 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers
Gender All
Age group 20 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (2)
Lead Sponsor Collaborator
Samsung Medical Center GENECAST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Performance of the EGFR assay ADPS EGFR Mutation Test using plasma sample from clinical stage IB-IIIA NSCLC patients (reference: EGFR assay in tissue specimen) Immediately before the surgery
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