- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01004783
Biomarkers in Tumor Tissue Samples From Young Patients With Very Low Risk Wilms Tumors
Validation of Prognostic Markers for Very Low Risk Wilms Tumors
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth J. Perlman, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AREN10B1
- COG-AREN10B1 (Other Identifier: Children's Oncology Group)
- CDR0000657973 (Other Identifier: Clinical Trials.gov)
- NCI-2011-02199 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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