Ignite Creation Date:
2024-05-06 @ 12:57 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01697163
Status:
UNKNOWN
Last Update Posted:
2012-10-02
First Post:
2012-09-12
Brief Title:
De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors
Sponsor:
Severance Hospital
Organization:
Severance Hospital
Study Overview
Official Title:
Pilot Study to Identify the Mechanism of De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors EGFR-TKIs in NSCLC With EGFR Mutation
Status:
UNKNOWN
Status Verified Date:
2012-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is based on the following hypothesis De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes
Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN HGF and IGFR To identify genetic mutations amplification and protein over expression as predictive markers of treatment outcomes investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC
Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN HGF and IGFR To identify genetic mutations amplification and protein over expression as predictive markers of treatment outcomes investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC
Detailed Description:
Investigators will prospectively enroll patients who match the following criteria pathologically proven unresectable NSCLC planning to treat with EGFR-TKI patients with activating EGFR mutations and available tissue sample for DNA extraction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None