Laboratory Study Using Samples From Patients With Non-Small Cell Lung Cancer Treated on Clinical Trial CASE-2507
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|ClinicalTrials.gov Identifier: NCT00907699|
Recruitment Status : Withdrawn (Slow Accrual)
First Posted : May 22, 2009
Last Update Posted : July 24, 2014
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.
|Condition or disease||Intervention/treatment|
|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|
- 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).
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|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|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||February 2013|
Genetic: DNA analysis
- 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 ]
- Difference of PFS between those with and without T790M mutation [ Time Frame: At the time of the second biopsy or surgical procedures ]
- Difference of clinical response rate between T790M mutation statuses [ Time Frame: At the time of the second biopsy or surgical procedures ]
- Predictive value of mutation status on clinical response [ Time Frame: At the time of the second biopsy or surgical procedures ]
- Association between T790M mutation and baseline clinical-pathological factors and smoking status [ Time Frame: At the time of the second biopsy or surgical procedures ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907699
|Principal Investigator:||Afshin Dowlati, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|