Collaborative Human Tissue Network

描述（由申请人提供）：协作人体组织网络是一个成功的计划，以增加人体组织的供应和质量，以支持癌症研究的延续。伯明翰的亚拉巴马大学（UAB），作为CHTN的南部分部（SD），自1987年以来有效地参与了所有CHTN在国家一级的行动。已经建立的政策和指导方针为癌症研究人员提供了一个可靠的来源，可以获得广泛的专业加工，良好表征和高质量的人体组织以及相关的组织病理学和人口统计学数据。然而，生物储存库业务正在出现新的挑战。目前癌症研究的进展，包括围绕个性化医疗研究的问题，导致对组织样本的需求增加和更复杂的请求。同时，医疗护理的变化，如术前治疗，使用高分辨率成像代替组织诊断，以及不断变化的监管环境正在影响组织收集。特别处的领导团队已采取积极主动的态度，以满足癌症研究人员未来的需要。(1)通过招募更多的参与研究中心来加强操作;增加档案石蜡块用于转移性病变和未经治疗的病变 原发性肿瘤;使用新的技术，包括硝酸纤维素印迹，获得小组织标本的等分试样;和快速尸检程序的发展。这些措施还伴随着增加对研究者使用替代组织的教育（例如，（2）通过参与外部认证程序，加强质量保证和质量控制;（3）通过扩大使用病人辩护律师，加强道德和监管立场。信息系统对所有生物库功能至关重要，SD建议开发一个利用新时代互操作性和链接大数据系统的研究人员IT系统。它还建议更加重视信息技术系统的培训和能力测试，同时更多地利用网络获取标准作业程序并进行培训。SD重申其对整个CHTN业务的承诺。除了领导层的持续参与外，它还继续与各个部门进行重大合作，包括为微阵列提供组织和对当前IT系统的修改进行β测试。自2008年以来，SD已向264名研究人员提供了20，287份新鲜，冷冻和固定的人体等分试样。值得注意的是，在CHTN网络中，它提供复杂的标本，包括在采集后30分钟内处理的组织等分试样;宏观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研究人员的随访。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.