Collaborative Human Tissue Network

描述(由申请人提供)：合作人体组织网络是一项成功计划的延续，该计划旨在增加人类组织的供应和质量，以支持癌症研究。阿拉巴马大学伯明翰分校(UAB)作为CHTN的南部分部(SD)，自1987年以来一直有效地参与了CHTN在国家一级的所有业务。已经建立的政策和指南为癌症研究人员提供了一个可靠的来源，提供了广泛的经过专业处理、特征良好的高质量人体组织以及相关的组织病理学和人口统计学数据。然而，对生物库操作的新挑战正在出现。目前癌症研究的进展，包括围绕个性化医学研究的问题，导致了对组织样本的需求增加和更复杂的要求。与此同时，医疗保健的变化，如术前治疗、使用高分辨率成像而不是组织诊断，以及不断变化的监管环境正在影响组织收集。该署的领导班子采取了积极主动的态度，以满足癌症研究人员未来的需要。(1)通过招募更多的参与地点来加强行动；更多地使用档案石蜡块来治疗转移性病变和未经治疗 这些研究包括：原发肿瘤；使用新技术，包括硝酸纤维蛋白印迹，以获得等分的小组织标本；以及开发快速尸检程序。与此同时，增加了对调查人员关于使用替代组织(例如，尸检、石蜡切片)和标本限制的教育；(2)通过参与外部认证过程，加强质量保证和质量控制；(3)通过扩大患者权益倡导者的使用，加强道德和监管立场。信息学系统对所有生物信息库的功能至关重要，SD建议开发一个调查人员的IT系统，利用新时代的互操作性和连接的大数据系统。它还建议更加重视信息技术系统的培训和熟练程度测试，同时更多地利用网络获取和培训标准作业程序。运输署重申，会致力于该中心的整体运作。除了领导层的持续参与外，它还继续与各司进行重要的合作努力，包括为微阵列提供组织，以及对当前信息技术系统的修改进行测试。自2008年以来，该处已向264名调查人员提供了20,287个新鲜、冷藏和固定的人体等量样本。值得注意的是，在CHTN网络内，它提供复杂的标本，包括在收集后30分钟内处理的组织等份；大体解剖的石蜡和冷冻组织和mRNA/DNA样本，以及详细的临床信息和对调查人员的跟踪。它是新鲜组织样本和体液的领先供应商之一，也是非洲裔美国患者样本的领先供应商。

DESCRIPTION (provided by applicant): The Collaborative Human Tissue Network is a continuation of a successful program to increase the supply and quality of human tissues to support research in cancer. The University of Alabama at Birmingham (UAB), as the Southern Division (SD) of the CHTN, has participated effectively in all CHTN operations at the national level since 1987. The policies and guidelines that have been established have resulted in a dependable source for cancer researchers of a wide range of expertly processed, well-characterized and high quality human tissues with associated histopathologic and demographic data. New challenges to biorepository operations are emerging, however. The current advances in cancer research, including the issues surrounding research into personalized medicine, have resulted in an increase in demand for tissue samples and more complex requests. Concurrently, changes in medical care, such as preoperative therapy, use of high resolution imaging instead of tissue diagnoses, as well as a changing regulatory environment are affecting tissue collections. The leadership team of the SD has taken a proactive stance to meet the future needs of cancer investigators. (1) Enhancement of operations through recruitment of additional participating sites; increased use of archival paraffin blocks for metastatic lesions and untreated primary tumors; use of novel techniques, including nitrocellulose blots, for obtaining aliquots of small tissue specimens; and development of a rapid autopsy program. These are accompanied by increased education of investigators as to use of alternative tissues (e.g., autopsy, paraffin blocks) and to specimen limitations; (2) Enhancement of quality assurance and quality control through participation in external accreditation processes; and (3) Enhancement of the ethical and regulatory stance through expansion of utilization of patient advocates. The informatics system is critical to all biorepository functions and the SD proposes development of an Investigators' IT system that utilizes new-era interoperability and linked big-data systems. It als proposes an increased emphasis on training and proficiency testing in IT systems, coupled with greater utilization of the Web for access to and training in SOPs. The SD reaffirms its commitment to the operations of the CHTN as a whole. In addition to ongoing involvement at the leadership level, it continues significant collaborative efforts with individual divisions, including supplying tissues for microarrays and beta-testing of modifications of the current IT system. Since 2008, the SD has provided 20,287 fresh, frozen and fixed human aliquots to 264 investigators. Notably, within the CHTN network it provides complex specimens including aliquots of tissue processed within 30 minutes of collection; macrodissected paraffin and frozen tissues and mRNA/DNA samples as well as detailed clinical information and follow-up to investigators. It is one of the leading providers of fresh tissue samples and body fluids and the leading provider of samples from African-American patients.