COG Biospecimen Bank

 描述（由申请人提供）：儿童肿瘤组（COG）是国家临床试验网络（NCTN）的儿科临床试验组。超过90%的美国和加拿大儿童和青少年癌症患者在COG机构接受治疗，没有种族，民族或地理偏见的注册，允许近人口为基础的临床，转化和基础研究。COG已经建立了从入组COG申办的临床试验的患者中收集和储存肿瘤和非疾病生物标本的良好记录，其中大多数包括随机治疗问题。COG生物标本库（COG BB）位于全国儿童医院生物病理学中心，旨在为研究界提供高质量的儿科和青少年人类恶性生物标本。每年，COG BB从超过225个COG机构的大约5，500名COG患者接收和储存超过100，000份标本，并将大约10，000份标本分发给批准的研究者。该银行还提供核酸分离，病理学审查，虚拟显微镜，临床参考实验室测试和信息学计划等服务。本提案支持从入组COG III期和大型II期试验（每年约4，000例患者）的患者中采集、处理和分发生物标本。COG BB旨在通过集中收集、质量控制、储存和分发程序，直接促进和支持儿科癌症诊断和治疗方面的杰出研究。COG BB将继续努力提供最新的基于生物储存库的技术创新和最佳实践，从而不断提高我们的运营能力，研究者对生物标本的访问，研究者的满意度以及这些宝贵资源的管理。在适当的监管指导方针下，并与COG统计和数据中心合作，COG BB将通过确保适当跟踪生物标本以及与现有人口统计学，临床，生物学，治疗和结局数据的联系来支持尖端研究的转化方面。最后，COG BB将为研究人员提供全面的数据库解决方案和动态信息学工具，以促进儿科癌症研究，包括使用生物标本IT导航器和NCTN生物标本前门服务。

 DESCRIPTION (provided by applicant): 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 BB), located within the Biopathology Center at Nationwide Children's Hospital, aims to provide high-quality pediatric and adolescent human malignant biospecimens to the research community. Annually, the COG BB receives and banks over 100,000 specimens from approximately 5,500 COG patients from over 225 COG institutions, and distributes approximately 10,000 specimens to approved investigators. The bank also offers services such as nucleic acid isolations, pathology review, virtual microscopy, clinical reference laboratory testing, and informatics initiatives. This proposal supports the collection, processing, and distribution of biospecimens from patient enrolled on COG Phase III and large Phase II trials (approximately 4,000 patients per year). The COG BB 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 BB 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 Statistical and Data Center, the COG BB will support translational aspects of cutting-edge research by ensuring appropriate tracking of biospecimens as well as linkages to existing demographic, clinical, biological, treatment, and outcome data. Finally the COG BB will provide investigators with a comprehensive database solution and dynamic informatics tools that facilitate pediatric cancer research, including the use of the Biospecimen IT Navigator and the NCTN Biospecimen front door services.