Laboratory Study Using Samples From Patients With Non-Small Cell Lung Cancer Treated on Clinical Trial CASE-2507
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and RNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at biomarkers in tumor tissue and blood samples from patients with non-small cell lung cancer.
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: fluorescence in situ hybridization
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Study of Epithelial Growth Factor Receptor Mutations in Tumor Specimens and Blood Samples From Patients With Non-Small Cell Lung Cancer Enrolled on Clinical Trial CASE-2507|
- Predictive value of T790M mutation status of the second biopsy (before maintenance therapy on CASE-2507) on progression-free survival (PFS) [ Time Frame: At the time of the second biopsy or surgical procedures ] [ Designated as safety issue: No ]
- Difference of PFS between those with and without T790M mutation [ Time Frame: At the time of the second biopsy or surgical procedures ] [ Designated as safety issue: No ]
- Difference of clinical response rate between T790M mutation statuses [ Time Frame: At the time of the second biopsy or surgical procedures ] [ Designated as safety issue: No ]
- Predictive value of mutation status on clinical response [ Time Frame: At the time of the second biopsy or surgical procedures ] [ Designated as safety issue: No ]
- Association between T790M mutation and baseline clinical-pathological factors and smoking status [ Time Frame: At the time of the second biopsy or surgical procedures ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||August 2008|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Genetic: DNA analysis
- Identify mutations in epidermal growth factor receptor (EGFR) in non-small cell lung cancer specimens from clinical trial CASE-2507.
- Investigate EGFR DNA copy-number changes.
- Determine abnormalities of other pathways, such as the c-MET and PI3K pathways as potential mechanisms of resistance.
OUTLINE: This is a multicenter study.
DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907699
|Principal Investigator:||Afshin Dowlati, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|