NRG Oncology Biospecimen Bank

项目总结： NRG肿瘤学(以下简称NRG)，NCI支持的国家临床试验网络(NCTN)的成员， 成立于2014年，由国家外科辅助乳肠项目合并而成 (NSABP)、放射治疗肿瘤组(RTOG)和妇科肿瘤组(GOG)。 这三个由美国国家癌症研究所(NCI)支持的传统癌症合作小组有150多个 多年实践定义、多机构、第二阶段和第三阶段实践的累积经验 改变癌症临床试验。自成立以来，NRG在实现其目标方面取得了重大进展 通过以下途径改善成人非血液系统恶性肿瘤患者的病程和生活质量 进行其临床研究。它特别定义了感兴趣的患者群体，那些有性别的人- 特定的恶性肿瘤和/或那些具有局部或局部晚期疾病的疾病在NCTN内是独一无二的， 构成了一大群相对未被充分调查的癌症患者。支持这些活动 自2015年以来一直是NRG肿瘤学生物库(下称NRG-BB)， 处理、注释和存储来自103期14,356名患者的259,415份生物标本 I、II和III成人NCTN和NCORP试验。这些生物标记物已用于集成、集成、 和探索性翻译科学来回答癌症中的一系列关键问题，直接导致82 极具影响力和实践变化的出版物。NRG肿瘤学计划每年招收多达3183名患者 NCI资助的NRG和NCORP赞助的癌症临床试验的未来一年。用于与试验相关的 NRG-BB将收集、处理和管理未来的活动和翻译科学项目 来自参加II和III期临床治疗试验的患者的生物样品，以保持准确和 有效的肿瘤和正常组织信息库以及相关的临床、流行病学和描述性资料 生物制品信息。NRG-BB将最大限度地提高生物杀虫剂和它们的 通过使用标准化和最佳的保存、储存、质量保证和 分配方法。我们将以标准化和公平的方式销售和分发未经确认的样品 通过继续与NRG肿瘤学密切合作，向NRG肿瘤学内外的所有合格研究人员提供态度 NCTN导航器和前门服务。与其他NCTN组织的生物库和 在NCI集团银行委员会的支持下，我们将继续协调生物检疫活动和流程。 最后，我们将利用我们的分布式基础设施来支持和/或执行创新的基因组学 由NRG肿瘤学进行的多臂靶向治疗试验的患者分配分析。健壮 信息学被要求让翻译科学家知道NRG-BB中有什么可用，并 将生物样品公平地分配给NRG内外的翻译科学界 肿瘤学。我们已经实施了一个强大和集成的样本跟踪和报告系统 (STARS)覆盖我们三个NRG-BB表演站点的生物信息学平台。这个常见的IT平台 在3个生物谱库站点之间实现了更高的服务水平，互操作性 并可与我们的NRG-BB合作伙伴自由交换数据，以及加强我们与 SDMC。此外，这个新平台加强了与集团银行的对外联系 委员会、国家情报局和导航员和前门项目。 相关性： 高质量和注释良好的相关生物标本的收集、管理和分发 有了NRG临床试验数据，将导致验证肿瘤预后生物标志物的翻译研究 以及对治疗反应的预测，最终导致癌症患者的治疗得到改善。这些 活动将支持提高生物标本的质量，并扩大翻译科学家的机会， 从而导致更高质量的研究，并为个性化方法确定合适的患者 改善癌症护理。

Project summary: NRG Oncology (hereafter NRG), a member of the NCI-supported National Clinical Trials Network (NCTN), was created in 2014 through the merger of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG). These three National Cancer Institute (NCI)-supported legacy cancer cooperative groups had over 150 years cumulative experience in the conduct of practice-defining, multi-institutional, Phase II and III practice changing clinical cancer trials. Since its inception, NRG has made significant progress toward its goal of improving the duration and quality of lives of adults with specific non-hematologic malignancies through the conduct of its clinical research. Its specifically defined patient populations of interest, those with gender- specific malignancies, and/or those with localized or locally advanced disease, are unique within the NCTN, constituting a large and relatively under-investigated cohort of cancer patients. Underpinning these activities has been the NRG Oncology Biospecimen Bank (hereafter NRG-BB) that has since 2015 received, processed, annotated and stored 259,415 biospecimens from over 14,356 patients enrolled on 103 phase I, II and III adult NCTN and NCORP trials. These biospecimens have been used for integral, integrated, and exploratory translational science to answer a range of key questions in cancer directly leading to 82 highly influential and practice changing publications. NRG Oncology plans to enroll up to 3,183 patients per year in future NCI-funded NRG and NCORP sponsored cancer clinical trials. For use in trial-related activities and future translational science projects the NRG-BB will collect, process and manage biospecimens from patients enrolled in Phase II & III clinical treatment trials to maintain an accurate and effective repository of tumor and normal tissues with associated clinical, epidemiologic, and descriptive biospecimen information. The NRG-BB will maximize the quality and quantity of biospecimens and their derivatives through the utilization of standardized and optimal preservation, storage, quality assurance and distribution methods. We will market and distribute de-identified samples in a standardized and equitable manner to all qualified investigators both within and outside NRG Oncology by continue to work closely with the NCTN Navigator and "front door" services. Working with the biobanks from other NCTN groups and the Group Banking Committee of the NCI, we will continue to harmonize biospecimen activities and processes. Finally, we will capitalize on our distributed infrastructure to support and/or perform innovative genomic analyses for patient assignment to multi-arm targeted therapy trials conducted by NRG Oncology. Robust informatics is required to allow translational scientists to know what is available within the NRG-BB and to equitably distribute biospecimens to the translational science community both within and outside NRG Oncology. We have implemented a robust and integrated specimen Tracking and Reporting System (STARS) bioinformatics platform across our three NRG-BB performance sites. This common IT platform across the 3 biospecimen bank sites has permitted an improved service level for the group, interoperability and freely exchangeable data with our NRG-BB partners and opportunities to enhance our links with the SDMC. Moreover, this new platform has permitted better external linkages with the Group Banking Committee, the NCI and with the Navigator and Front Door project. Relevance: The collection, management and distribution of high quality and well annotated biospecimens associated with NRG clinical trials data will lead to translational studies for validating biomarkers of tumor prognosis and prediction of response to therapy, ultimately leading to improved treatment of cancer patients. These activities will support improved quality of biospecimens, and expanded access for translational scientists, thus leading to better quality research and identifying appropriate patients for personalized approaches to improved cancer care.