SNPMiner Trials (Home Page)
Report for Clinical Trial NCT00907699
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
Name: DNA analysis
Description: DNA is 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.
Type: Genetic
Name: RNA analysis
Description: RNA is extracted from tumor samples. 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).
Type: Genetic
Name: fluorescence in situ hybridization
Description: 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).
Type: Genetic
Name: gene expression analysis
Description: 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).
Type: Genetic
Name: mutation analysis
Description: 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).
Type: Genetic
Name: polymerase chain reaction
Description: 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).
Type: Genetic
Name: reverse transcriptase-polymerase chain reaction
Description: 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).
Type: Genetic
Name: laboratory biomarker analysis
Description: 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).
Type: Other
Primary Outcomes
Measure: Predictive value of T790M mutation status of the second biopsy (before maintenance therapy on CASE-2507) on progression-free survival (PFS) Time: At the time of the second biopsy or surgical procedures
Measure: Difference of PFS between those with and without T790M mutation Time: At the time of the second biopsy or surgical procedures
Measure: Difference of clinical response rate between T790M mutation statuses Time: At the time of the second biopsy or surgical procedures
Measure: Predictive value of mutation status on clinical response Time: At the time of the second biopsy or surgical procedures
Measure: Association between T790M mutation and baseline clinical-pathological factors and smoking status Time: At the time of the second biopsy or surgical procedures
Time Perspective: Cross-Sectional
Case-Only
There is one SNP
SNPs
1 T790M
Predictive value of T790M mutation status of the second biopsy (before maintenance therapy on CASE-2507) on progression-free survival (PFS). --- T790M ---
Difference of PFS between those with and without T790M mutation. --- T790M ---
Difference of clinical response rate between T790M mutation statuses. --- T790M ---
Association between T790M mutation and baseline clinical-pathological factors and smoking status. --- T790M ---