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

Completed

• Conditions: Rhabdoid Tumor of the Kidney; Stage II Wilms Tumor; Stage IV Wilms Tumor; Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Stage I Wilms Tumor; Stage III Wilms Tumor; Clear Cell Sarcoma of the Kidney; Stage V Wilms Tumor
• Interventions: Genetic: DNA methylation analysis; Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: diagnostic laboratory biomarker analysis

• Registration Number: NCT01118078
• Lead Sponsor: Children's Oncology Group

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-06
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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
  • Associated precursor lesions (rests)
  • Histologic subtype
  • Site and time of recurrence
  • Days of follow-up
  • Time and reasons for death (e.g., tumor, toxicity, infection, or other)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biomarker (DNA methylation, gene expression, RT-PCR)	gene expression analysis	Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression analysis, DNA methylation, and genomic re-sequencing by microarray analysis-based methods, including PCR analysis, DNA methylation analysis-specific RT-PCR, and quantitative RT-PCR (reverse transcriptase-polymerase chain reaction)
Biomarker (DNA methylation, gene expression, RT-PCR)	microarray analysis	Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression analysis, DNA methylation, and genomic re-sequencing by microarray analysis-based methods, including PCR analysis, DNA methylation analysis-specific RT-PCR, and quantitative RT-PCR (reverse transcriptase-polymerase chain reaction)
Biomarker (DNA methylation, gene expression, RT-PCR)	diagnostic laboratory biomarker analysis	Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression analysis, DNA methylation, and genomic re-sequencing by microarray analysis-based methods, including PCR analysis, DNA methylation analysis-specific RT-PCR, and quantitative RT-PCR (reverse transcriptase-polymerase chain reaction)
Biomarker (DNA methylation, gene expression, RT-PCR)	DNA methylation analysis	Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression analysis, DNA methylation, and genomic re-sequencing by microarray analysis-based methods, including PCR analysis, DNA methylation analysis-specific RT-PCR, and quantitative RT-PCR (reverse transcriptase-polymerase chain reaction)
Biomarker (DNA methylation, gene expression, RT-PCR)	reverse transcriptase-polymerase chain reaction	Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression analysis, DNA methylation, and genomic re-sequencing by microarray analysis-based methods, including PCR analysis, DNA methylation analysis-specific RT-PCR, and quantitative RT-PCR (reverse transcriptase-polymerase chain reaction)

Primary Outcome Measures

Name	Time	Method
Genomic gains and losses in high-risk Wilms tumor	After completion of biomarker analysis
Transcription patterns involved in the pathogenesis of Wilms tumor	After completion of biomarker analysis
Genetic mutations involved in the pathogenesis of Wilms tumor	After completion of biomarker analysis

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States