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

January 20, 2016 updated by: GenoSaber

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non Small Cell Lung Cancer(stage Ⅲ-Ⅳ)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Plasma and tissue matching
predicting clinical efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EGFR mutation detection of FFPE and plasma samples by Human EGFR Mutations Quantitative Detection Kit
Time Frame: 6 months
Each subject will be collected 3-10 FFPE samples and 3 ml plasma samples.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenoSaber

Collaborators

Sun Yat-sen University
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGFR2015-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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