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Central Laboratory Core

中心实验室核心

基本信息

批准号：
10706305
负责人：
TIMOTHY J. WILKIN
金额：
$ 10.67万
依托单位：
WEILL MEDICAL COLL OF CORNELL UNIV
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-20 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10706305
关键词：
Accreditation Address Adult American Anus Brazil CD8B1 gene Cancer Center Cells Cervical Clinical Trials Collection DNA Documentation Ensure Evaluation Female Formalin Future Genotype Goals Guidelines HIV HPV E7 HPV-High Risk Human Papilloma Virus Vaccine Human Papilloma Virus-Related Malignant Neoplasm Human Papillomavirus Human papilloma virus infection Immunologic Tests Immunologics Infrastructure International Investigation Laboratories Laboratory Study Latin America Manuscripts Methylation Mexico Molecular Virology Natural History Papillomavirus Transforming Protein E6 Paraffin Embedding Pathologist Pathology Peer Review Persons Policies Prevention Procedures Process Publications Puerto Rico Recommendation Research Research Assistant Research Design Research Personnel Research Support Resources Sampling Services South Africa Specimen Standardization Testing Universities Vaccine Clinical Trial Viral Woman adjudication biobank biological specimen archives cervical biopsy college experience laboratory experience laboratory experiment male medical schools men operation oral HPV programs square foot vaccine trial

项目摘要

CENTRAL LABORATORY CORE PROJECT SUMMARY/ABSTRACT The Central Laboratory Core serves as the central storage facility for specimens collected by the U54 Partnership for Prevention of HPV-Associated Cancers in People Living with HIV: Brazil, Mexico and Puerto Rico (PHAC-BMPR) Program, co-led by Drs. Anna R Giuliano and Luisa L Villa. This core builds on the extensive infrastructure and international experience of the HPV Infection in Men (HIM) Study laboratory core in operation since 2004 supporting research conducted in the US, Mexico, and Brazil. Originally a core to support HPV natural history research the core infrastructure expanded in 2012 to include HPV vaccine clinical trial operations in Mexico and South Africa. In addition, the core builds on the extensive experience and infrastructure in Brazil managing the biorepository and cervical HPV testing in support of the Ludwig-McGill HPV Natural History Study since 1994. The overall goal of the CL Core is to receive, process, store, and release high-quality, well-annotated biospecimens in support of the three clinical trials proposed to reduce HPV-related cancers among men and women living with HIV in Latin America. In addition, the CL Core will provide centralized research-quality cervical pathology evaluation for endpoint adjudication, DNA extraction, HPV genotyping, and immunological evaluation for the proposed clinical trials. Core activities will be centralized in two laboratories, one led by Dr. Giuliano at the Moffitt Cancer Center and one led by Dr. Villa at the University of São Paulo, Brazil.

中心实验室核心项目总结/摘要中央实验室核心是U 54收集的标本的中央储存设施。预防艾滋病毒感染者HPV相关癌症的合作伙伴关系：巴西、墨西哥和波多黎各（PHAC-BMPR）计划，由安娜R朱利亚诺和路易莎L别墅博士共同领导。这个核心是建立在男性HPV感染（HIM）研究实验室的广泛基础设施和国际经验自2004年以来，该中心一直在运作，支持在美国、墨西哥和巴西进行的研究。最初是一个核心，支持HPV自然史研究核心基础设施在2012年扩大到包括HPV疫苗临床在墨西哥和南非进行试运营。此外，核心建立在丰富的经验，巴西的基础设施管理生物储存库和宫颈HPV检测，以支持Ludwig-McGill HPV自然史研究自1994年以来。CL核心的总体目标是接收、处理、存储和发布高质量，注释良好的生物标本，以支持三项临床试验，以减少拉丁美洲艾滋病毒感染者中与HPV相关的癌症此外，CL Core将提供集中的研究质量的宫颈病理学评价，用于终点裁定，DNA提取， HPV基因分型和拟定临床试验的免疫学评价。核心活动将是集中在两个实验室，一个由Giuliano博士在Moffitt癌症中心领导，另一个由Villa博士在巴西圣保罗大学。