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
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
- 否
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
