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

Non Small Cell Lung Cancer Clinical Trial

Official title: Human EGFR(Epidermal Growth Factor Receptor) Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR-TKI Resistant Mutation
• EGFR-TKI Sensitizing Mutation
• Non Small Cell Lung Cancer

• NCT number: NCT02661009
• Study type: Observational
• Source: GenoSaber
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2016