ECOG-ACRIN Biospecimen Bank to Support NCTN

项目摘要 ECOG-ACRIN(EA)代表着ECOG和ACRIN的合并，形成一个专注于 从癌症到癌症的整个治疗过程中改变实践的临床和转化性研究 通过管理晚期疾病及其影响进行预防和早期发现。此应用程序 是支持EA中央生物库和病理学的基础设施和银行业务 设施(EA CBPF)，一个高度协作、高效和有影响力的生物资源库，由 五个NCI国家临床试验网络(NCTN)生物谱库的合并，包括目前的一个 正在完成过渡。将生物储存库活动并入EA CBPF显著影响了 通过集中和继续标准和创新的生物储存库活动和加强 开发新的癌症预测生物标记物和治疗方法的能力。EA CBPF将 继续得到EA生物统计和数据管理中心(BDMC)、业务办公室、 其他NCTN单位、NCI赞助的项目和调查人员以及NCI。EA CBPF的目标是确保 从癌症患者获取的注释良好的人类生物标本的收集、储存和分发 参与NIH/NCI和NCTN NCI资助的临床治疗试验。EA CBPF的目标1是收集， 处理、存储、分类和分发恶性和非恶性组织、细胞、血液和其他液体 标本及其衍生物(例如，组织来源的和无细胞的DNA和RNA、蛋白质、外切体和 来自参加电针临床试验的患者的循环肿瘤细胞)，遵循美国国家癌症研究所的 并将标本与相关的临床、病理、免疫学和 NCTN计划中的分子数据；目标2是开发和利用常规数据和创新数据 Biospecimen资源，将有助于成功完成NCTN支持的临床试验 整合生物标志物及相关研究促进新型生物标志物驱动的发展 个性化癌症治疗策略；目标3是开发执行经典和 电针临床试验的组织、细胞、血液和其他体液标本的分子方法学 患者，包括有计划的未来巩固基于标本的功能，并提供专家 与NCTN支持的相关研究人员密切合作，对调查结果进行解释 临床试验；目标4是协助NIH/NCI NCTN和NCORP内外的研究人员 通过积极参与和领导高优先级项目的努力，获得用于研究的生物质谱学 作为NCTN导航器服务和癌症免疫监测中心(CIMAC)，以及 积极促进NCI集团银行委员会(GBC)的生物信息库协调活动 和NIH/NCI支持的样本库组织。

Project Summary ECOG-ACRIN (EA) represents the merger of ECOG and ACRIN to form a cooperative group focused on practice-changing clinical and translational research across the cancer care continuum from cancer prevention and early detection, through the management of advanced disease and its impact. This application is to support the infrastructure and banking operations for the EA Central Biorepository and Pathology Facility (EA CBPF), a highly collaborative, productive and impactful biorepository resulting from the consolidation of five NCI National Clinical Trials Network (NCTN) Biospecimen Banks, including one currently finalizing transition. The consolidation of biorepository activities into EA CBPF has significantly impacted operations by centralizing and continuing the standard and innovative biorepository activities and enhancing capabilities to develop novel predictive biomarkers and therapeutic approaches in cancer. EA CBPF will continue being assisted by the EA Biostatistics and Data Management Center (BDMC), Operations Offices, other NCTN units, NCI-sponsored programs and investigators, and the NCI. The goal of EA CBPF is to ensure the collection, storage, and distribution of well-annotated human biospecimens, procured from cancer patients participating in the NIH/NCI and NCTN NCI-funded clinical treatment trials. EA CBPF's Aim 1 is to collect, process, store, catalog, and distribute malignant and non-malignant tissues, cells, blood, and other fluid specimens and their derivatives (e.g., tissue-derived and cell free DNA and RNA, proteins, exosomes and circulating tumor cells) from patients enrolled in EA clinical trials following the NCI's “Best Practices for Biospecimen Resources” and to link the specimens to relevant clinical, pathologic, immunological and molecular data within the NCTN program; Aim 2 is to develop and utilize both routine and innovative biospecimen resources that will aid in the successful completion of NCTN-supported clinical trials based on integral biomarkers and of related correlative studies to promote the development of novel biomarker-driven personalized cancer therapeutic strategies; Aim 3 is to develop capabilities for performing classic and molecular methodologies on tissue, cell, blood, and other body fluid–based specimens from EA clinical trial patients, including planned future consolidation of specimen-based functions, and provide expert interpretation of the findings in close collaboration with the investigators leading the related NCTN- supported clinical trials; and Aim 4 is to assist investigators outside and within the NIH/NCI NCTN and NCORP to access biospecimens for research by participating actively, and leading efforts in high priority programs such as the NCTN Navigator services and the Center for Immune Monitoring of Cancer (CIMAC), as well as contributing actively to the biorepository harmonization activities of the NCI Group Banking Committee (GBC) and NIH/NCI-supported specimen banking organizations.