NCCTG Biospecimen Resource

描述（由申请人提供）： 北中央癌症治疗小组（NCCTG）的使命是通过在社区环境中进行高质量的临床和转化研究来改善癌症患者的生存时间和生活质量。NCCTG（生物标本资源）将通过提供来自NCCTG试验入组患者的上级生物标本来支持NCCTG的使命，这些生物标本1）经过充分和一致的注释，2）在优化的标准条件下采集，3）经过质量评估，4）在受控条件下储存，以便有效检索并分发给合格的研究人员。本申请的五个具体目标是：1）最大限度地从NCCTG和其他合作组临床试验入组的患者中采集生物标本。这一目标将有助于增加可用于转化研究的生物标本数量，以便能够容纳更多具有足够统计能力的研究; 2）一致和完整地注释收集的生物标本。这一目标将为转化研究提供一个关键要素，即定义标准临床病理指标、治疗、治疗反应和疾病结局的背景，在此背景下，将评估转化研究测量的生物学参数的意义; 3）制定收集、处理和储存生物标本的标准操作程序（SOP）。标准操作程序的使用将通过提供统一性来增强生物样本资源，使得用于给定转化研究的生物样本彼此可比; 4）开发用于分析生物样本的新方法。技术不断发展，扩大了我们分析生物标本的能力。在这个目标中，我们描述了三种技术，我们正在完善（组织微阵列构建）和开发（分析循环肿瘤细胞和提取RNA从福尔马林固定石蜡包埋的组织块）作为新的方法，扩大使用生物标本的例子;和5）提供监督的资源和机制，为研究界的资源。该目标将描述对生物样本资源的监督，以及我们将如何提供与请求生物样本的机制的公共链接。确定了优先次序系统和评价标准。

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.