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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01004783
Enrollment
165
Registered
2009-10-30
Start date
2009-10-31
Completion date
2010-11-30
Last updated
2015-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

stage I Wilms tumor, stage II Wilms tumor, epithelial predominant Wilms tumor

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 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

Interventions

GENETICDNA methylation analysis
GENETICgene expression analysis
GENETICmicroarray analysis
GENETICmutation analysis
GENETICpolymerase chain reaction
GENETICreverse transcriptase-polymerase chain reaction
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Patient with very low risk Wilms tumor registered on clinical trial COG-AREN03B2 * Patient with stage I or II epithelial tubular differentiated Wilms tumor registered on clinical trial COG-Q9401 (NWTS-5) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not Specified

Design outcomes

Primary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026