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

NCT ID: NCT02661009

Last Updated: 2016-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Plasma and tissue matching

No interventions assigned to this group

predicting clinical efficacy

No interventions assigned to this group

Eligibility Criteria

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

• 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

• 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:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: collaborator

GenoSaber

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EGFR2015-01

Identifier Type: -

Identifier Source: org_study_id