Trials / Completed
CompletedNCT01004783
Biomarkers in Tumor Tissue Samples From Young Patients With Very Low Risk Wilms Tumors
Validation of Prognostic Markers for Very Low Risk Wilms Tumors
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 165 (actual)
- Sponsor
- Children's Oncology Group · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | DNA methylation analysis | |
| GENETIC | gene expression analysis | |
| GENETIC | loss of heterozygosity analysis | |
| GENETIC | microarray analysis | |
| GENETIC | mutation analysis | |
| GENETIC | polymerase chain reaction | |
| GENETIC | reverse transcriptase-polymerase chain reaction | |
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2009-10-30
- Last updated
- 2015-05-07
Source: ClinicalTrials.gov record NCT01004783. Inclusion in this directory is not an endorsement.