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Clinical Trials/NCT01118078
NCT01118078
Completed
Not Applicable

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 Candidate Molecular Targets for High-Risk Wilms Tumors

Children's Oncology Group1 site in 1 country185 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Clear Cell Sarcoma of the Kidney
Sponsor
Children's Oncology Group
Enrollment
185
Locations
1
Primary Endpoint
Genomic gains and losses in high-risk Wilms tumor
Status
Completed
Last Updated
9 years ago

Overview

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 Description

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of high-risk Wilms tumor meeting ≥ 1 of the following criteria:
  • Relapsed disease
  • Anaplastic disease
  • Clear cell sarcomas of the kidney
  • Rhabdoid tumors
  • Registered on NWTS-4, NWTS-5 (now COG-Q9401), or participation in AREN03B2 protocols with clinical follow-up \> 3 years
  • Banked frozen tumor samples and paired normal DNA available with clinical data points, including the following:
  • Age, race, and gender
  • Stage and reason for stage
  • Tumor weight

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (1)

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