SWOG Biospecimen Bank to Support NCI NCTN

项目摘要 SWOG是国家临床试验网络(NCTN)中的一个成人临床试验癌症小组 癌症研究所(NCI)。SWOG临床试验包括一系列癌症类型(例如，乳腺癌、肺癌、结肠癌、前列腺癌、 白血病、黑色素瘤、淋巴瘤和多发性骨髓瘤)。SWOG Biosecimen Bank(Biobank)，位于 生物病理中心(全国儿童医院阿比盖尔·韦克斯纳研究所的一部分)， 旨在采购、加工、储存和分发作为NCI的主要组成部分收集的生物检疫制剂- 赞助的临床试验。这些生物标本与外科和病理学的人口统计信息有关。 根据SWOG方案登记的研究参与者的报告、治疗和随访数据。在审查和 批准后，优先将生物检疫制剂分发给临床定义的特定SWOG研究人员 试验方案。在计划研究的需求得到解决后，剩余(遗产)被储存起来 生物样品可以通过NCTN导航器分发给SWOG内外的其他研究人员。这个 SWOG集团和Biobank礼宾还可以促进对SWOG遗留生物显微镜的访问 目前已上传到导航器中。此流程旨在反映遗留问题的流程 关于导航器系统的生物检疫，包括SWOG生物库和 提交建议书之前，SWOG统计和数据管理中心。生物库是一个正在运作的 和可行的部分SWOG的临床和转化医学计划，并专注于整合 诊断、治疗、实验室和临床数据，以回答临床和转化性研究中的问题。 SWOG生物库的工作假设是，高质量、临床注释和癌症的银行- 相关的人类生物标本，与分子签名/标记相联系，将大大促进和进一步 推进癌症临床研究。为了支持这一努力，SWOG生物库管理着这些生物标本 根据严格的指导方针和基于当前生物仓库最佳实践的标准操作程序 以及最新的实验室技术。生物库的经验，加上对质量的坚定承诺 和完整的手术，使其独特地能够提供准确和有效的肿瘤和 正常样本以及相关的临床、流行病学和受保护的健康信息。SWOG生物库 旨在协调和扩大一般银行业务做法和创新技术，这将继续 促进分子生物学研究并增加研究人员对临床研究试验的参与 NCI赞助的集团银行委员会(GBC)。SWOG生物库也计划支持加工， 向癌症免疫监测和分析中心(CIMAC)储存和分发生物检疫制剂。

Project Summary SWOG is an adult clinical trials cancer group within the National Clinical Trials Network (NCTN) of the National Cancer Institute (NCI). SWOG clinical trials include a range of cancer types (e.g., breast, lung, colon, prostate, leukemia, melanoma, lymphoma, and multiple myeloma). The SWOG Biospecimen Bank (Biobank), located in the Biopathology Center (part of the Abigail Wexner Research Institute of Nationwide Children's Hospital), was designed to procure, process, bank, and distribute biospecimens collected as a major component of NCI- sponsored clinical trials. These biospecimens are linked to demographic information, surgical and pathological reports, and treatment and follow-up data of study participants enrolled on SWOG protocols. Upon review and approval, biospecimens are prioritized for distribution to the specific SWOG investigators defined in the clinical trial protocols. After the needs of the planned research have been addressed, residual (legacy) banked biospecimens can be distributed to other investigators within and outside SWOG via the NCTN Navigator. The SWOG Group and Biobank Concierges can also facilitate access to SWOG legacy biospecimens that are not currently uploaded in Navigator. This process has been designed to mirror the process for legacy biospecimens on the Navigator system and includes a feasibility assessment by the SWOG Biobank and the SWOG Statistical and Data Management Center prior to proposal submission. The Biobank is a functioning and viable part of SWOG's clinical and translational medicine program, and focuses on the integration of diagnostic, therapeutic, laboratory, and clinical data to answer questions in clinical and translational research. The SWOG Biobank works under the hypothesis that banking of high quality, clinically-annotated and cancer- related human biospecimens, linked to molecular signatures/markers, will significantly facilitate and further advance clinical cancer research. To support this effort, the SWOG Biobank manages these biospecimens under strict guidelines and standard operating procedures based on current Best Practices for biorepositories and the latest laboratory technologies. The Biobank's experience, coupled with a firm commitment to quality and integrity operations, makes it uniquely able to provide an accurate and effective resource of tumor and normal samples with associated clinical, epidemiologic, and protected health information. The SWOG Biobank aims to harmonize and expand general banking practices and innovative technologies, which will continue to facilitate molecular biology research and increase investigator participation in clinical research trials via the NCI-sponsored Group Banking Committee (GBC). The SWOG Biobank also plans to support the processing, banking, and distribution of biospecimens to the Cancer Immune Monitoring and Analysis Centers (CIMACs).