Clinical trial NCT02661009: Human EGFR Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
Official title: Human EGFR(Epidermal Growth Factor Receptor) Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
EGFR-TKI Resistant Mutation
EGFR-TKI Sensitizing Mutation
Keywords: NSCLC
EGFR
EGFR-TKI
PCR
Lead sponsor: GenoSaber
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Pulmonary Hospital, Shanghai, China
name: Sun Yat-sen University
name: Shanghai Chest Hospital
First posted: 2016-01-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non Small Cell Lung Cancer(stage Ⅲ-Ⅳ)

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.

Eligibility 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

Primary outcomes:
measure: EGFR mutation detection of FFPE and plasma samples by Human EGFR Mutations Quantitative Detection Kit
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: