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

GenoSaber

Status: Unknown

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02661009

EGFR2015-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Plasma and tissue matching group:

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

Trial design

1,000 participants in 2 patient groups

Plasma and tissue matching

predicting clinical efficacy