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Completed

NCT Number: NCT01118078

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DNA methylation analysis

Genetic

Undergo DNA methylation analysis

gene expression analysis

Genetic

Undergo gene expression analysis

microarray analysis

Genetic

Undergo microarray analysis

Other names: gene expression profiling

reverse transcriptase-polymerase chain reaction

Genetic

Undergo RT-PCR

Other names: RT-PCR

diagnostic laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Genomic gains and losses in high-risk Wilms tumor

    Time frame: After completion of biomarker analysis

  2. Transcription patterns involved in the pathogenesis of Wilms tumor

    Time frame: After completion of biomarker analysis

  3. Genetic mutations involved in the pathogenesis of Wilms tumor

    Time frame: After completion of biomarker analysis

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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 Candidate Molecular Targets for High-Risk Wilms Tumors

Important dates

Study start
2010
Primary completion
2016
First posted
May 6, 2010
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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