Human EGFR Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)

• Conditions: Non Small Cell Lung Cancer; EGFR-TKI Sensitizing Mutation; EGFR-TKI Resistant Mutation

• Registration Number: NCT02661009
• Lead Sponsor: GenoSaber

Brief Summary

In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical performance of the EGFR quantitative kits.

1. methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods.

2. analysis of the relationship between the type and proportion of EGFR sensitive mutation and EGFR-TKI benefit.

Detailed Description

According to the types of samples and the purpose of the study, the research consists of two groups: plasma and tissue matching group and predicting clinical efficacy group. The samples of the plasma and tissue matching group are the same period plasma and matched FFPE(formalin-fixed paraffin-embedded tissue)samples which will be collected before the first time patients accept any anti-tumor treatment. The samples of predicting clinical efficacy group are FFPE samples which will be collected before the patients receive EGFR-TKI treatment. In addition, the subjects have the complete prognostic follow-up data.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2016-01
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-20
• Last Update Submitted: 2016-01-20
• Study First Posted: 2016-01-21
• Last Update Posted: 2016-01-21
• Primary Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 18~80 years old
• Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
• Did not receive any anti-tumor treatment.
• Sufficient samples for analysis

Exclusion Criteria

• Female patients of childbearing potential who are nursing or are pregnant.
• Samples are collected after patients receiving anti-tumor treatment.
• The plasma sample hemolysis.
• Tumor cells are not found in FFPE samples.
• Incomplete information of subjects

predicting clinical efficacy group:

Inclusion Criteria:

• 18~80 years old
• Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
• At least one measurable focus
• With EGFR-TKI treatment
• Complete follow-up information after EGFR-TKI treatment
• Sufficient samples for analysis

Exclusion Criteria:

• FFPE samples are collected after EGFR-TKI treatment.
• Female patients of childbearing potential who are nursing or are pregnant.
• Tumor cells are not found in FFPE samples.
• Incomplete information of subjects

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EGFR mutation detection of FFPE and plasma samples by Human EGFR Mutations Quantitative Detection Kit	6 months	Each subject will be collected 3-10 FFPE samples and 3 ml plasma samples.