NRG Oncology Biospecimen Bank

 描述（由申请人提供）：NRG肿瘤学（NRG）是一个新成立的国家临床试验网络（NCTN）小组，通过国家外科辅助乳腺和肠道项目（NSABP）、放射治疗肿瘤学小组（RTOG）和妇科肿瘤学小组（GOG）的协调努力和科学合并创建。NRG肿瘤学生物标本库（NRG-BB）将由RTOG、GOG和NSABP这三个传统生物标本资源组成，并将其整合为一个单一的储存库，用于储存作为NRG肿瘤学临床试验一部分采集的所有生物标本。NRG Oncology和NCI已同意在未来由NRG赞助的癌症临床试验中每年招募多达5，099名患者。我们将收集、处理和管理参加II期和III期临床治疗试验的患者的生物标本，以保持准确有效的肿瘤和正常组织储存库以及相关的临床、流行病学和描述性生物标本信息，用于试验相关活动和未来的转化科学项目。国家生物资源小组将通过采用标准化和最佳的保存、储存、质量保证和分配方法，最大限度地提高生物标本及其衍生物的质量和数量。我们将通过使用Biospecial IT Navigator和NCTN Biospecial“前门”服务，以标准化和公平的方式向NRG肿瘤学内外的所有合格研究者销售和分发去识别样本。我们将与其他NCTN集团和NCI集团银行委员会的生物样本库合作，协调生物样本活动和流程。最后，我们将开发分布式基础设施，以支持和/或执行创新的基因组分析，用于将患者分配到NRG肿瘤学进行的多组靶向治疗试验。需要强大的信息学，以使翻译科学家了解NRG-BB中的可用内容，并将生物标本公平地分配给NRG肿瘤学内外的翻译科学界。我们已经预见到了这一需求，已经使用一个通用的标本跟踪和报告系统（STARS）生物信息学平台协调和整合了我们的IT资源。通过在3个传统生物样本库中采用通用IT平台，提高了集团的服务水平，实现了与我们的NRG-BB合作伙伴的互操作性和自由交换数据，并有机会加强我们与SDMC的联系。此外，这一新平台还使集团银行委员会、NCI以及Navigator和Front Door项目能够更好地与外部联系。

 DESCRIPTION (provided by applicant): NRG Oncology (NRG) is a newly constituted National Clinical Trials Network (NCTN) group created through the coordinated efforts and scientific merger of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG). The NRG Oncology Biospecimen Bank (NRG-BB) will be formed from the three legacy biospecimen resources of the RTOG, GOG and NSABP into a single repository for all biospecimens collected as part of NRG Oncology clinical trials. NRG Oncology and the NCI have agreed to enroll up to 5,099 patients per year in future NCI-funded NRG-sponsored cancer clinical trials. We 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, for use in trial-related activities and future translational science projects. 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 utilizing Biospecimen IT Navigator and NCTN Biospecimen "front door" services. Working with the biobanks from other NCTN groups and the Group Banking Committee of the NCI, we will harmonize biospecimen activities and processes. Finally, we will develop 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 anticipated this need by already harmonizing and consolidating our IT resources using a common Specimen Tracking and Reporting System (STARS) bioinformatics platform. This adoption of a common IT platform across the 3 legacy biospecimen banks 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.