Core C - Clinical Research and Biorepository

核心 C - 临床研究和生物样本库

• 批准号: 9122347
• 负责人: Corey Casper
• 金额: $ 24.38万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9122347
• 关键词: Acquired Immunodeficiency Syndrome; Adherence; Africa South of the Sahara; Clinic; Clinical; Clinical Research; Cohort Studies; Collaborations; Collection; Data; Data Analyses; Enrollment; Epidemiology; Future; HIV; HIV Seropositivity; Individual; Institutes; Investigation; Kaposi Sarcoma; Laboratories; Lead; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Medical; Mentorship; Natural History; Non-Hodgkin' s Lymphoma; Office of Administrative Management; Participant; Patients; Population; Procedures; Protocols documentation; Recruitment Activity; Research; Research Infrastructure; Research Personnel; Risk; Science; Specimen; Time; Training; Translational Research; Uganda; Work; biobank; experience; leadership development; programs; prospective; repository; research study; treatment response

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.

临床和知识库核心旨在促进所有三个联盟项目的实验室研究，同时也受益于行政核心的管理，并通过以下具体目标与导师核心合作，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、筛选和登记患有艾滋病定义的恶性肿瘤或有患艾滋病定义的恶性肿瘤风险的受试者; 2）对参与者进行前瞻性跟踪研究，严格遵守研究程序; 3）帮助维持一个强大的生物标本库，以促进乌干达艾滋病定义恶性肿瘤的自然史研究，并向参与所有三个方案项目的实验室提供这些标本; 4）促进收集和分析从临床研究参与者那里获得的数据，以便能够描述乌干达艾滋病定义恶性肿瘤治疗反应的临床、流行病学和医学决定因素。为了实现这些目标，核心将利用哈钦森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。在坎帕拉的合作研究诊所工作的50多名工作人员都接受过艾滋病毒相关恶性肿瘤研究以及良好临床和实验室实践的培训，该诊所研究了7 000多名参与者，目前维持着一个生物储存库，其中有15万多份来自艾滋病毒和癌症患者的标本。核心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卡波西肉瘤、非霍奇金淋巴瘤和浸润性宫颈癌患者的标本和数据。与此同时，临床研究和实验室科学方面的受训人员将与指导核心小组合作，纳入核心小组的活动，继续培养一支优秀的乌干达研究人员队伍，领导今后与艾滋病毒有关的恶性肿瘤的研究。