NCCTG Biospecimen Resource

描述(由申请人提供)： 北中癌症治疗小组(NCCTG)的使命是通过在社区环境中进行高质量的临床和转化性研究来改善癌症患者的持续时间和生活质量。NCCTG(Biosecimen Resources)将支持NCCTG的使命，为参加NCCTG试验的患者提供优质的生物样本，这些样本1)有完整和一致的注释，2)在优化的标准条件下收集，3)经过质量评估，4)储存在受控条件下，允许有效检索并分发给合格的研究人员。这项应用的五个具体目标是：1)最大限度地收集参加NCCTG和其他合作小组临床试验的患者的生物标本。这一目标将有助于增加可用于翻译研究的生物标本的数量，以便能够容纳更多具有足够统计能力的研究；2)对收集的生物标本进行一致和完整的注释。这一目标将为转译研究提供一个关键要素，即确定标准临床病理指数、治疗方法、治疗反应和疾病结局的背景，其中将评估转译研究所测量的生物参数的重要性；3)制定收集、处理和储存生物标本的标准操作程序(SOP)。标准操作规程的使用将通过提供一致性来增强生物谱资源，从而使特定翻译研究的生物谱彼此具有可比性；4)开发分析生物谱的新方法。技术在不断发展，扩展了我们分析生物群落的能力。在这一目标中，我们描述了我们正在提炼和开发的三项技术(组织微阵列构建)和开发(循环肿瘤细胞分析和从福尔马林固定的石蜡包埋组织块中提取RNA)，作为扩大生物标本使用的新方法的例子；以及5)为研究界提供对资源的监督和获取资源的机制。这一目标将描述对生物检疫资源的监督，以及我们将如何提供与生物检疫申请机制的公共链接。确定了优先顺序体系和评价标准。

DESCRIPTION (provided by applicant): The mission of the North Central Cancer Treatment Group (NCCTG) is to improve the duration and quality of life of cancer patients by performing high-quality clinical and translational research in the community setting. The NCCTG (Biospecimen Resource will support the NCCTG mission by providing superior biospecimens from patients enrolled on NCCTG trials that 1) are fully and consistently annotated, 2) have been collected under optimized standard conditions, 3) have undergone quality assessment, and 4) are stored under controlled conditions allowing efficient retrieval for distribution to qualified researchers. The five specific aims of this application are 1) To maximize collection of biospecimens from patients enrolled on NCCTG and other cooperative group clinical trials. This aim will serve to increase the numbers of biospecimens available for translational research so that more studies with sufficient statistical power can be accommodated; 2) To consistently and completely annotate biospecimens collected. This aim will serve to provide a crucial element in translational research, namely to define the context of standard clinical-pathologic indices, treatments, response to treatment, and disease outcome within which the significance of the measured biologic parameters of translational studies will be evaluated; 3) To develop standard operating procedures (SOP) for collecting, processing, and storing biospecimens. The use of SOPs will enhance the Biospecimen Resource by providing uniformity so that biospecimens for a given translational study are comparable with one another; 4) To develop new methods for analysis of biospecimens. Technologies are constantly developing that expand our ability to analyze biospecimens. In this aim we describe three technologies that we are refining (tissue microarray construction) and developing (analysis of circulating tumor cells and extraction of RNA from formalin-fixed paraffin embedded tissue blocks) as examples of new methodologies that expand the use of biospecimens; and 5) To provide oversight to the resource and a mechanism for access to the resource for the research community. This aim will describe the oversight of the Biospecimen Resource and how we will provide a public link to the mechanism for requesting biospecimens. A prioritization system and evaluation criteria are defined.