Core C - Clinical Research and Biorepository

临床和储存核心旨在促进所有三个财团项目的实验室调查，同时也受益于行政核心的管理，并通过以下具体目标与指导核心合作，为科学领导力发展提供机会：1)从乌干达艾滋病毒阳性人群中招募、筛选和登记研究方案的受试者，这些受试者患有或有患艾滋病恶性肿瘤风险；2)前瞻性随访受试者，严格遵守研究程序；3)帮助维持一个健全的生物标本库，以促进对乌干达艾滋病恶性肿瘤自然历史的研究，并将这些标本提供给参与所有三个方案项目的实验室；4)促进收集和分析从临床研究参与者那里获得的数据，以便确定乌干达境内艾滋病界定恶性肿瘤治疗效果的临床、流行病学和医学决定因素。为了实现这些目标，Core将利用由Hutchinson中心和乌干达癌症研究所合作建立的完善的转化和临床研究基础设施。该合作组织在坎帕拉的研究诊所有50多名工作人员，他们都接受过艾滋病毒相关恶性肿瘤研究以及良好的临床和实验室实践工作方面的培训，该诊所研究了7000多名参与者，目前保存着一个生物库，其中有来自艾滋病毒和癌症患者的15万多份标本。Core将支持选定的工作人员提供正在进行的前瞻性队列研究中患有卡波西肉瘤、非霍奇金淋巴瘤和侵袭性宫颈癌或有风险的患者的标本和数据。与此同时，临床研究和实验室科学方面的学员将与指导核心合作，纳入核心的活动，继续培养一支优秀的乌干达研究人员骨干队伍，以领导今后对艾滋病毒相关恶性肿瘤的研究。

The Clinical and Repository Core seeks to facilitate the laboratory investigations of all three Consortium projects, while also benefitting from the management of the Administrative Core and providing opportunities for scientific leadership development in collaboration with the Mentorship Core through the following Specific Aims: 1) To recruit, screen, and enroll into research protocols subjects from Ugandan HIV-positive populations with or at risk for AIDS-Defining malignancies; 2) To follow participants prospectively on studies, maintaining close adherence to study procedures; 3) To help maintain a robust biospecimen repository to facilitate the study of the natural history of AIDS-defining malignancies in Uganda and to make these specimens available to the laboratories involved in all three program projects; 4) To facilitate the collection and analysis of data obtained from participants in clinical research studies to allow for the characterization of the clinical, epidemiologic and medical determinants of response to treatment of AIDS-defining malignancies in Uganda. To achieve these aims, the Core will leverage a well-established translational and clinical research infrastructure that has been built by the collaboration between the Hutchinson Center and the Uganda Cancer Institute. A staff of more than 50 individuals who have all been trained in HIV-associated malignancy research and good clinical and laboratory practice work at the collaboration's research clinic in Kampala, which has studied more than 7,000 participants and currently maintains a biorepository with more than 150,000 specimens from patients with HIV and cancer. The Core will support selected staff to provide specimens and data from patients in ongoing prospective cohort studies with or at risk for Kaposi Sarcoma, non-Hodgkin Lymphoma and invasive cervical cancer. At the same time, trainees in clinical research and laboratory science will be integrated into the Core's activities in collaboration with the Mentorship Core to continue to develop a cadre of outstanding Ugandan investigators to lead future studies in HIV-associated malignancies.