Clinical Trial: Biomarkers in Tissue Samples From Patients With High-Risk Wilms Tumor

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative High-Risk Renal Tumor Project: Application of Array-Based Methods and Next Generation Sequencing to Identify Ca

Brief Summary: This research study is studying biomarkers in tissue samples from patients with high-risk Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.

Detailed Summary:

OBJECTIVES:

I. To assess genomic gains and losses in high risk renal tumors, including up to 80 favorable histology Wilms tumors that relapse (RFHWT), 50 anaplastic Wilms tumors (UHWT), 15 clear cell sarcomas of the kidney (CCSK), and 40 rhabdoid tumors (RT) using a high density genetic platform to survey for recurrent copy number variations and allelic imbalances. II. To define transcription patterns within 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using a high throughput platform for global gene expression. III. To define DNA methylation patterns within 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using a high throughput platform. IV. To identify genetic mutations involved in the pathogenesis of Wilms tumor, and in the development of relapse and anaplasia through the study of 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using next generation sequencing tools.

V. To facilitate the integration of the above databases and allow meaningful access by investigators through the infrastructure provided by TARGET, including its data portal and associated caBIG tool.

OUTLINE: This is a multicenter study.

Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression, DNA methylation, and genomic re-sequencing by array-based methods, including PCR analysis, methylation-specific reverse transcriptase-PCR (RT-PCR), and quantitative RT-PCR.


Sponsor: Children's Oncology Group

Current Primary Outcome:

  • Genomic gains and losses in high-risk Wilms tumor [ Time Frame: After completion of biomarker analysis ]
  • Transcription patterns involved in the pathogenesis of Wilms tumor [ Time Frame: After completion of biomarker analysis ]
  • Genetic mutations involved in the pathogenesis of Wilms tumor [ Time Frame: After completion of biomarker analysis ]


Original Primary Outcome:

  • Genomic gains and losses in high-risk Wilms tumor
  • Transcription patterns involved in the pathogenesis of Wilms tumor
  • Genetic mutations involved in the pathogenesis of Wilms tumor


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: May 5, 2010
Date Started: May 2010
Date Completion:
Last Updated: May 17, 2016
Last Verified: May 2016