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

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01004783
Collaborator
National Cancer Institute (NCI) (NIH)
165
Enrollment
13
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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

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 Design

Study Type:
Observational
Actual Enrollment :
165 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validation of Prognostic Markers for Very Low Risk Wilms Tumors
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Nov 1, 2010

Outcome Measures

Primary Outcome Measures

  1. 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 []

  2. 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 []

  3. Utility of NFYA, STRA6, TOB2, PDCD4, and SP3 mRNA expression to predict relapse in VLRWT []

  4. 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Children's Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Elizabeth J. Perlman, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01004783
Other Study ID Numbers:
  • AREN10B1
  • COG-AREN10B1
  • CDR0000657973
  • NCI-2011-02199
First Posted:
Oct 30, 2009
Last Update Posted:
May 7, 2015
Last Verified:
May 1, 2015
Keywords provided by Children's Oncology Group
stage I Wilms tumor
stage II Wilms tumor
epithelial predominant Wilms tumor
Additional relevant MeSH terms:
Kidney Neoplasms
Wilms Tumor

Study Results

No Results Posted as of May 7, 2015