Non Small Cell Lung Cancer Clinical Trial
Official title:
Human EGFR(Epidermal Growth Factor Receptor) Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
Verified date | December 2015 |
Source | GenoSaber |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GenoSaber | Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Sun Yat-sen University |
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 |
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