Biomarkers in Tumor Tissue Samples From Young Patients With Very Low Risk Wilms Tumors
NCT ID: NCT01004783
Last Updated: 2015-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
165 participants
OBSERVATIONAL
2009-10-31
2010-11-30
Brief Summary
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PURPOSE: This clinical trial studies biomarkers in tumor tissue samples from young patients with very low risk Wilms tumors.
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Detailed Description
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* 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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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DNA methylation analysis
gene expression analysis
loss of heterozygosity analysis
microarray analysis
mutation analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Elizabeth J. Perlman, MD
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Other Identifiers
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COG-AREN10B1
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000657973
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02199
Identifier Type: REGISTRY
Identifier Source: secondary_id
AREN10B1
Identifier Type: -
Identifier Source: org_study_id
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