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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02661009
• Other study ID #: EGFR2015-01
• Status: Not yet recruiting
• Phase: N/A
• First received: January 18, 2016
• Last updated: January 20, 2016
• Start date: January 2016

Study information

• Verified date: December 2015
• Source: GenoSaber
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
GenoSaber	Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EGFR mutation detection of FFPE and plasma samples by Human EGFR Mutations Quantitative Detection Kit	Each subject will be collected 3-10 FFPE samples and 3 ml plasma samples.	6 months	No