COG Biospecimen Bank to Support NCI NCTN (U24)

项目摘要 儿童肿瘤学小组(COG)是国家临床试验的儿科临床试验小组 网络(NCTN)。超过90%的美国和加拿大患有癌症的儿童和青少年 在COG机构接受治疗，对注册没有种族、民族或地理偏见，允许近 以人群为基础的临床、转化和基础研究。COG在以下方面建立了良好的跟踪记录 收集和储存参加COG赞助的患者的肿瘤和非疾病生物标本 临床试验，其中大部分包括随机治疗问题。COG生物谱库(COG Biobank)，位于生物病理中心(阿比盖尔·韦克斯纳研究所的一部分，位于 全国儿童医院)，旨在为儿童和青少年提供高质量的恶性肿瘤 向研究界传播生物武器。在审查和批准后，生物检疫剂优先用于 分配给临床试验方案中定义的COG研究人员。经过规划后的需求 研究已经解决，剩余(遗留)库中的生物样本可以分发给其他 通过NCTN导航器、COG集团和Biobank礼宾在COG内外进行调查 还可以方便地访问目前未在导航器中上载的COG遗留生物样本。为 所有生物菌素分配项目，由COG生物库和COG进行可行性评估 统计和数据管理中心(SDMC)在提交建议书之前完成。这 计划支持从登记的患者收集、处理和分发生物检疫试剂 COG赞助的试验。合作人体组织网络(CHTN)的儿科部门 促进经批准的遗留生物检疫剂的分发。 COG生物库旨在直接促进和支持在诊断和治疗方面的杰出研究 通过集中收集、质量控制、存储和分发来治疗儿科癌症 程序。COG生物库将继续努力提供最新的基于生物信息库的 技术创新和最佳实践，使我们的运营不断改进 能力、调查员获得生物标本的机会、调查员满意度以及对这些的管理 宝贵的资源。在适当的监管指导下，并与COG SDMC合作， COG生物库将通过确保适当的跟踪来支持尖端研究的翻译方面 以及与现有人口学、临床、生物学、治疗和结果的联系 数据。最后，COG生物库将为调查人员提供全面的数据库解决方案和 促进儿科癌症研究的动态信息学工具。COG生物库还计划 支持生物标记物的加工、储存和分发，以支持癌症免疫监测和 分析中心(CIMAC)。

Project Summary The Children’s Oncology Group (COG) is the pediatric clinical trials group of the National Clinical Trials Network (NCTN). Over 90% of United States and Canadian children and adolescents with cancer are treated at COG institutions with no racial, ethnic or geographic bias to registration, allowing for near- population-based clinical, translational and basic research. COG has established a strong track record of collecting and banking tumor and non-diseased biospecimens from patients enrolled in COG-sponsored clinical trials, most of which include randomized treatment questions. The COG Biospecimen Bank (COG Biobank), located within the Biopathology Center (part of the Abigail Wexner Research Institute at Nationwide Children’s Hospital), aims to provide high-quality pediatric and adolescent human malignant biospecimens to the research community. Upon review and approval, biospecimens are prioritized for distribution to the COG 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 COG via the NCTN Navigator The COG Group and Biobank Concierges can also facilitate access to COG legacy biospecimens that are not currently uploaded in Navigator. For all biospecimen distribution projects, a feasibility assessment by the COG Biobank and the COG Statistical and Data Management Center (SDMC) is completed prior to proposal submission. This proposal supports the collection, processing, and distribution of biospecimens from patient enrolled on COG-sponsored trials. The Pediatric Division of the Cooperative Human Tissue Network (CHTN) then facilitates the distribution of the approved legacy biospecimens. The COG Biobank seeks to directly promote and support outstanding research in the diagnosis and treatment of pediatric cancer through centralized collection, quality control, storage, and distribution procedures. The COG Biobank will continue efforts to provide the latest biorepository-based technological innovations and best practices, resulting in constant improvements in our operational capabilities, investigator access to biospecimens, investigator satisfaction, and the stewardship of these precious resources. Under proper regulatory guidelines and in association with the COG SDMC, the COG Biobank will support translational aspects of cutting-edge research by ensuring appropriate tracking of biospecimens as well as linkage to existing demographic, clinical, biological, treatment, and outcome data. Finally, the COG Biobank will provide investigators with a comprehensive database solution and dynamic informatics tools that facilitate pediatric cancer research. The COG Biobank also plans to support the processing, banking, and distribution of biospecimens to the Cancer Immune Monitoring and Analysis Centers (CIMACs).