Clinical Trial: Biomarkers in Tumor Tissue Samples From Young Patients With Very Low Risk Wilms Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Validation of Prognostic Markers for Very Low Risk Wilms Tumors
Brief Summary:
RATIONALE: Studying samples of 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.
PURPOSE: This clinical trial studies biomarkers in tumor tissue samples from young patients with very low risk Wilms tumors.
Detailed Summary:
OBJECTIVES:
- To validate the utility of CUGBP2, HMGA2, and MEIS2 mRNA expression and 11p15 methylation to define a population of pediatric patients with very low risk Wilms tumor (VLRWT) that have virtually no risk of relapse.
- To validate the utility of WT-1 mutation and 11p15 loss of heterozygosity analysis to determine a population of VLRWT that have a higher risk of relapse when not treated with chemotherapy.
- To validate the utility of NFYA, STRA6, TOB2, PDCD4, and SP3 mRNA expression to predict relapse in VLRWT.
- To investigate the feasibility of broadening the definition of VLRWT through analysis of stage I and II epithelial differentiated tumors registered on clinical trial COG-Q9401 (NWTS-5) for CUGBP2, HMGA2, MEIS2, and 11p15 methylation.
OUTLINE: Previously banked tumor tissue samples are analyzed for mRNA expression of CUGBP2, HMGA2, and MEIS2 via reverse-transcriptase (RT)-PCR and are classified as loss of heterozygosity (LOH), loss of imprinting, or neither via 11p15 analysis. Samples are also analyzed for WT-1 mutation via quantitative PCR and 11p LOH using 11p15 methylation analysis and expression of NFYA, STRA6, TOB2, PDCD4, and SP3 via quantitative RT-PCR
Sponsor: Children's Oncology Group
Current Primary Outcome:
- Utility of CUGBP2, HMGA2, and MEIS2 mRNA expression and 11p15 methylation to define a population of pediatric patients with very low risk Wilms tumor (VLRWT) that have virtually no risk of relapse
- Utility of WT-1 mutation and 11p15 loss of heterozygosity analysis to determine a population of VLRWT that have a higher risk of relapse when not treated with chemotherapy
- Utility of NFYA, STRA6, TOB2, PDCD4, and SP3 mRNA expression to predict relapse in VLRWT
- Feasibility of broadening the definition of VLRWT through analysis of stage I and II epithelial differentiated tumors registered on clinical trial COG-Q9401 (NWTS-5) for CUGBP2, HMGA2, MEIS2, and 11p15 methylation
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Children's Oncology Group
Dates:
Date Received: October 29, 2009
Date Started: October 2009
Date Completion:
Last Updated: May 6, 2015
Last Verified: May 2015