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

NCT02661009 | Unknown DMC

• 1 other identifier: EGFR2015-01
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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. 1.methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods.
2. 2.analysis of the relationship between the type and proportion of EGFR sensitive mutation and EGFR-TKI benefit.

Conditions

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

Keywords

NSCLC; EGFR; EGFR-TKI; PCR

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Plasma and tissue matching

predicting clinical efficacy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non Small Cell Lung Cancer(stage Ⅲ-Ⅳ)

You may qualify if:

• \~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

You may not qualify if:

• 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:
• \~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
• 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.

Sponsors & Collaborators

• GenoSaber: lead
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Sun Yat-sen University: collaborator
• Shanghai Chest Hospital: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 21, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Last Updated: January 21, 2016

Record last verified: 2015-12