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Biomarkers in Young Patients With Neuroblastoma

2016年5月17日 更新者:Children's Oncology Group

Therapeutically Applicable Research to Generate Effective Treatments (TARGET) for Neuroblastoma

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in young patients with neuroblastoma.

研究概览

详细说明

OBJECTIVES:

Primary

  • To discover the therapeutically relevant driver mutations in high-risk pediatric neuroblastoma.

Secondary

  • To identify a set of highly annotated neuroblastoma specimens (primary tumors and cell lines) for comprehensive genomic analyses, validation studies, resequencing efforts, and future functional assays.
  • To define genome-wide DNA copy number and allelic status in at least 300 high-risk and 50 low-risk neuroblastoma primary untreated tumors, and 30 human neuroblastoma-derived cell lines.
  • To define the genome-wide methylation profile of neuroblastoma in a minimum of 200 high-risk cases.
  • To define the genome-wide microRNA expression profile of neuroblastoma in a minimum of 200 high-risk cases.
  • To define genome-wide RNA expression signatures, including splice variations, in the same tumors and cell lines studied above.
  • To identify mutations in candidate therapeutic targets using a staged resequencing strategy with ultimate genome-scale next generation resequencing of 3 genomes for 200 high-risk cases: the neuroblastoma genome and transcriptome as well as the paired constitutional genome.
  • To characterize the relapsed high-risk neuroblastoma genome and epigenome.

OUTLINE: This is a multicenter study.

Previously collected samples are analyzed to define the genome-wide DNA copy number and allelic status; to define the genome-wide methylation profile of high-risk neuroblastoma cases; to define the genome-wide microRNA expression profile of high-risk neuroblastoma cases; to define the genome-wide RNA expression and relating gene expression to DNA copy number and gene polymorphisms, DNA methylation, and microRNA expression; to resequence three genomes: the neuroblastoma genome, the transcriptome, and the paired constitutional genome; and to characterize the relapsed high-risk neuroblastoma genome and epigenome.

PROJECTED ACCRUAL: A total of 300 tumor samples from patients with high-risk disease, 50 tumor samples from patients with low-risk primary neuroblastoma, and 30 human neuroblastoma-derived cell lines will be accrued for this study.

研究类型

观察性的

注册 (预期的)

380

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 30年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients registered on the COG-ANBL00B1 Neuroblastoma Biology Study

描述

DISEASE CHARACTERISTICS:

  • Registered on the COG-ANBL00B1 Neuroblastoma Biology Study or its CCG or POG precursor
  • Sufficient high-quality tumor material available for the proposed studies meeting the following criteria:

    • Tissue histopathologic review with > 70% tumor cells in sections adjacent to areas used for nucleic acid preparation
    • Matched normal cells (blood or uninvolved bone marrow) available
    • ≥ 5 μg DNA available
    • ≥ 5 μg RNA available
    • ≥ 200 mg tissue available
  • Tumor samples must meet 1 of the following criteria:

    • High-risk tumor

      • With or without MYCN amplification
      • With or without tumor progression or relapse (during ≥ 2.5 years of follow up)
      • Patients aged 18 months to 5 years
    • Low-risk tumor

      • Primary neuroblastoma
      • Stage I disease (completely resected)
      • No event in ≥ 3 years of follow up
    • Cell lines representing diverse high-risk genetics including with or without MYCN amplification and clinical course (at diagnosis or after relapse)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
Discovery of therapeutically relevant driver mutations

次要结果测量

结果测量
Identification of a set of neuroblastoma specimens for analyses
Genome-wide DNA copy number and allelic status
Genome-wide methylation profile
Genome-wide microRNA expression profile
Genome-wide RNA expression signatures
Identification of mutations in candidate therapeutic targets
Characterization of the relapsed high-risk neuroblastoma genome and epigenome

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年7月1日

初级完成 (实际的)

2016年5月1日

研究完成 (实际的)

2016年5月1日

研究注册日期

首次提交

2010年7月23日

首先提交符合 QC 标准的

2010年7月23日

首次发布 (估计)

2010年7月26日

研究记录更新

最后更新发布 (估计)

2016年5月18日

上次提交的符合 QC 标准的更新

2016年5月17日

最后验证

2016年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • ANBL10B1
  • COG-ANBL10B1 (其他标识符:Children's Oncology Group)
  • CDR0000681912 (其他标识符:Clinical Trials.gov)
  • NCI-2011-02246 (注册表标识符:CTRP (Clinical Trial Reporting Program))

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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