COG Biospecimen Bank to Support NCI NCTN (U24)

COG 生物样本库将支持 NCI NCTN (U24)

• 批准号: 10405653
• 负责人: Mignon Lee-Cheun Loh
• 金额: $ 341.11万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-22 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10405653
• 关键词: Address; Adolescent; Advocate; Affect; Basic Science; Biological Response Modifier Therapy; Biological Specimen Banks; Canada; Child; Childhood; Childhood Cancer Treatment; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Network; Clinical trial protocol document; Collaborations; Collection; Communities; Conduct Clinical Trials; Cooperative Human Tissue Network; Data; Data Reporting; Databases; Diagnosis; Education; Enrollment; Ensure; Fostering; Geography; Guidelines; Human; Immunologic Monitoring; Improve Access; Institution; Leadership; Malignant - descriptor; Malignant Childhood Neoplasm; Malignant Neoplasms; Mission; National Clinical Trials Network; Patients; Pediatric Hospitals; Pediatric Oncology; Pediatric Oncology Group; Play; Procedures; Process; Protocols documentation; Quality Control; Randomized; Research; Research Institute; Research Personnel; Residual state; Resources; Role; Site; Standardization; System; Translational Research; Treatment Side Effects; Treatment outcome; United States; anticancer research; base; biobank; cancer therapy; data management; data sharing; design; early phase clinical trial; improved; informatics tool; operation; population based; racial and ethnic; satisfaction; success; technological innovation; treatment trial; tumor; working group

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).

项目摘要 儿童肿瘤组（COG）是国家临床试验委员会的儿科临床试验组。 网络（NCTN）。超过90%的美国和加拿大儿童和青少年患有癌症， 在COG机构治疗，没有种族，民族或地理偏见的登记，允许近- 基于人口的临床、转化和基础研究。COG已经建立了强大的跟踪记录， 从入组COG申办的研究的患者中收集并储存肿瘤和非疾病生物标本， 临床试验，其中大多数包括随机治疗问题。生物样本库（COG Biobank），位于生物病理学中心（Abigail Wexner研究所的一部分， 全国儿童医院），旨在提供高质量的儿科和青少年人类恶性肿瘤 生物标本的研究社区。在审查和批准后，生物标本优先用于 分发给临床试验方案中规定的COG研究者。在计划的需求之后， 研究已经解决，剩余的（遗产）库存生物标本可以分发给其他 通过NCTN Navigator COG Group和Biobank Concierges，COG内外的研究人员 还可以方便地访问当前未上传到Navigator中的COG遗留生物标本。为 所有生物样本分发项目，由COG生物库和COG进行可行性评估 统计和数据管理中心（SDMC）在提案提交前完成。这 提案支持从入组的患者中采集、处理和分发生物标本， COG申办的试验。合作人体组织网络（CHTN）的儿科部门， 便于分发已批准的遗留生物标本。 COG生物库旨在直接促进和支持诊断和治疗领域的杰出研究， 通过集中收集、质量控制、储存和分发治疗儿童癌症 程序. COG生物库将继续努力提供最新的基于生物仓的 技术创新和最佳实践，使我们的业务不断改善 能力、研究者对生物标本的访问、研究者满意度以及这些的管理 宝贵的资源。根据适当的监管指南，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转化方面 生物标本的数量以及与现有人口统计学、临床、生物学、治疗和结局的联系 数据最后，COG生物库将为研究者提供全面的数据库解决方案， 动态信息学工具，促进儿科癌症研究。COG生物银行还计划 支持生物标本的处理、储存和分发，以进行癌症免疫监测， 分析中心（CIMAC）。