Study of Tumor Tissue From Patients With Melanoma Treated on Clinical Trial EST-1690
Recruitment status was: Not yet recruiting
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at tumor tissue samples from patients with melanoma treated on clinical trial EST-1690.
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: polymerase chain reaction
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Official Title:||Molecular Prognostic Factor Analysis in Melanoma|
- Prognostic role of several biomarkers on the outcome associated with melanoma using IHC [ Designated as safety issue: No ]
- Predictive role of these biomarkers in patients undergoing adjuvant interferon alfa therapy [ Designated as safety issue: No ]
- Correlation between the intensity of biomarker expression and survival in the observation and interferon-treated groups [ Designated as safety issue: No ]
- Prognostic role of these biomarkers on the outcome associated with melanoma using quantitative-PCR [ Designated as safety issue: No ]
- Prognostic role of gene expression on the outcome associated with melanoma [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
- To validate the prognostic role of several biomarkers suggested by gene expression profiling and tissue microarray (TMA) studies (e.g., NCOA3, SPP1, and RGS1) on the outcome associated with melanoma in the EST-1690 cohort using IHC analysis.
- To examine the potential predictive role of such biomarkers in patients undergoing adjuvant interferon alfa therapy.
- To analyze the correlation between the intensity of biomarker expression and survival of this cohort both in the observation and in the interferon-treated groups.
- To examine the prognostic role of these biomarkers on the outcome associated with melanoma in the EST-1690 cohort using quantitative-PCR.
- To isolate RNA from the primary specimens from patients enrolled in the EST-1690 cohort to assess the expression of genes suggested by cDNA microarray and IHC analyses (e.g., NCOA3, SPP1, and RGS1) as prognostic or predictive markers.
OUTLINE: Samples from the EST-1690 cohort are obtained and analyzed for several biomarkers (i.e., NCOA3, SPP1, and RGS1) via immunohistochemistry and quantitative PCR. RNA is isolated from the specimens to assess gene expression via quantitative PCR.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937781
|Study Chair:||Mohammed Kashani-Sabet, MD||University of California, San Francisco|