Biomarkers in Tumor Tissue Samples From Young Patients With Very Low Risk Wilms Tumors

Kidney Cancer Clinical Trial

Official title:

Validation of Prognostic Markers for Very Low Risk Wilms Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004783
• Other study ID #: AREN10B1
• Secondary ID: COG-AREN10B1CDR0
• Status: Completed
• Phase: N/A
• First received: October 29, 2009
• Last updated: May 6, 2015
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2015
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Cancer
• Wilms Tumor

Intervention

Genetic:
• DNA methylation analysis

• gene expression analysis

• loss of heterozygosity analysis

• microarray analysis

• mutation analysis

• polymerase chain reaction

• reverse transcriptase-polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Primary	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			No
Primary	Utility of NFYA, STRA6, TOB2, PDCD4, and SP3 mRNA expression to predict relapse in VLRWT			No
Primary	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			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database