NCT01118078

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 185 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clear Cell Sarcoma of the Kidney
• Recurrent Wilms Tumor and Other Childhood Kidney Tumors
• Rhabdoid Tumor of the Kidney
• Stage I Wilms Tumor
• Stage II Wilms Tumor
• Stage III Wilms Tumor
• Stage IV Wilms Tumor
• Stage V Wilms Tumor

Interventions

Type	Name	Description
GENETIC	DNA methylation analysis	Undergo DNA methylation analysis
GENETIC	gene expression analysis	Undergo gene expression analysis
GENETIC	microarray analysis	Undergo microarray analysis
GENETIC	reverse transcriptase-polymerase chain reaction	Undergo RT-PCR
OTHER	diagnostic laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-05-01
• Primary completion: 2016-05-01
• First posted: 2010-05-06
• Last updated: 2016-05-19

Locations

1 site across 1 country: United States