Human EGFR Mutations Quantitative Detection Kit (Real-tim... | NCT02661009

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

NCT02661009

Sponsor

GenoSaber

Status

Unknown status

Last Update Posted

Jan 21, 2016Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Sep 2016Estimated

Completion Date

Not provided

First Submitted Date

Jan 18, 2016

First Submission Date that Met QC Criteria

Jan 20, 2016

First Posted Date

Jan 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Name	Class
Shanghai Pulmonary Hospital, Shanghai, China	OTHER
Sun Yat-sen University	OTHER
Shanghai Chest Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Non Small Cell Lung Cancer(stage Ⅲ-Ⅳ)

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided