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临床试验/NCT01118078
NCT01118078已完成不适用

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 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
185
试验地点
1
主要终点
Genomic gains and losses in high-risk Wilms tumor

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 未提供

结局指标

主要结局

Genomic gains and losses in high-risk Wilms tumor

时间窗: After completion of biomarker analysis

Transcription patterns involved in the pathogenesis of Wilms tumor

时间窗: After completion of biomarker analysis

Genetic mutations involved in the pathogenesis of Wilms tumor

时间窗: After completion of biomarker analysis

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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