EGFR Mutation Detection From Advanced NSCLC Patient Tissue and Plasma in EGFR-TKI Treatment

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT02644889
• Lead Sponsor: GenoSaber

Brief Summary

This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-11
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-30
• Study Start: 2016-01
• Study First Posted: 2016-01-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-07
• Primary Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age older than 18 years and under 75 years
• Histologically and cytologically proven non-small Cell Lung Cancer
• Clinical stages Ⅲ ~ Ⅳ
• Not receive any anti-tumor treatment
• Eastern cooperative oncology group performance status (ECOG PS) =1~2
• Estimated survival time more than 3 months
• EGFR-TKI treatment for first-line or second-line
• Voluntary to participate in this clinical trial and sign the consent form

Exclusion Criteria

• Patients have received EGFR-TKI therapy before the study
• With other malignancy history in the recent 5 years before the study
• Pregnancy or breast feeding phase
• Inadequate samples for testing
• Follow-up compliance is poor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EGFR Mutation Detection of plasma samples for the following-up patients who take TKI.	From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years	In order to monitor the change of plasma EGFR mutation copy number.
EGFR Mutation Detection of FFPE and plasma samples	baseline	To evaluate the feasibility of plasma EGFR detection from non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs and evaluate the correlation of EGFR mutations and prognosis.