H2A Clinical Core

H2A 临床核心

• 批准号: 10259884
• 负责人: Jim Aizire
• 金额: $ 8.17万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-09 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10259884
• 关键词: Adherence; Advocate; Africa; Africa South of the Sahara; African; Age; Behavioral; Clinical; Clinical Data; Clinical assessments; Complex; Country; Data; Data Collection; Data Element; Data Set; Development; Ensure; Europe; Evaluation; Goals; HIV; Hepatitis B; Hepatitis B Virus; Hepatitis C virus; Hospitals; Image; Infection; Intercept; Interruption; Interview; Laboratories; Language; Lead; Leadership; Malignant Neoplasms; Measurement; Measures; Medical; Mentors; Methods; Monitor; Participant; Patients; Performance; Periodicity; Pilot Projects; Primary carcinoma of the liver cells; Procedures; Process; Protocols documentation; Questionnaires; Research; Research Personnel; Resources; Risk Factors; Role; Schistosoma mansonii infection; Secondary to; Senegal; Site; Standardization; Switzerland; Technology Transfer; Telemedicine; Testing; Time; Training; Uganda; Universities; base; career; chronic infection; clinical research site; cohort; data dictionary; data harmonization; data integration; data quality; design; experience; novel; quality assurance; recruit; research study; response

Hepatocellular carcinoma (HCC) is a very common and lethal cancer in Africa, and as patients with HIV live longer, the HCC burden may increase. In prior studies, our team identified chronic infection with hepatitis B and C viruses (HBV, HCV), HIV and Schistosomiasis mansoni as independent risk factors for HCC. Compared to the US, HCC in sub-Saharan Africa occurs at younger age and more advanced stage with survival of only months. Proposed is an East and West African partnership between colleagues at Makerere University in Uganda, Fann University in Senegal and Johns Hopkins University focused on HIV and hepatocellular carcinoma (HCC) in Africa: The H2A Consortium. Building on long-standing collaborative research, mentoring and clinical activities in both countries, our overarching goal is to reduce the heavy burden of HCC in sub- Saharan Africa. We advocate investigating cancer interception strategies using appropriate medical treatments to interrupt or reverse the impact of these HCC-causing infections. We will accomplish this objective by developing local capacity and performing important research. The Consortium represents a complex partnership between investigators, staff, hospitals, and universities in 4 countries representing East and West Africa, Switzerland and USA, with 6 clinical sites, 4 primary laboratories, and ~20 coinvestigators speaking English and French. The Clinical and Data Quality Core (CDQ) is designed to support the standardized rigorous data collection, management and analysis of Consortium data. CDQ will ensure that high quality data is rigorously collected, that assessment of clinical measurements and laboratory testing be standardized between sites, that data harmonization be effectively performed, and that high quality analytical datasets be produced in a timely manner. CDQ Core provides support for both Projects and to pilot projects through the Developmental Core. Support to both the scientific and capacity development objectives ensures that comprehensive, systematic and rigorous data collection, management and analysis in Consortium projects will appropriately maximize resources and have a high likelihood of scientific impact.

肝细胞癌 (HCC) 是非洲一种非常常见且致命的癌症，随着艾滋病毒患者的生存 时间越长，HCC 负担可能会增加。在之前的研究中，我们的团队发现了乙型肝炎的慢性感染 C 病毒（HBV、HCV）、HIV 和曼氏血吸虫病是 HCC 的独立危险因素。比较的 与美国相比，撒哈拉以南非洲地区的 HCC 发生年龄更小，阶段更晚期，生存期仅为 几个月。提议在马凯雷雷大学的同事之间建立东非和西非伙伴关系 乌干达、塞内加尔范恩大学和约翰霍普金斯大学专注于艾滋病毒和肝细胞 非洲癌症 (HCC)：H2A 联盟。建立在长期合作研究、指导的基础上 以及两国的临床活动，我们的总体目标是减轻亚裔 HCC 的沉重负担 撒哈拉非洲。我们主张使用适当的医疗方法研究癌症拦截策略 中断或扭转这些引起 HCC 的感染的影响。我们将通过以下方式实现这一目标 发展当地能力并开展重要研究。该财团代表着一个复杂的 代表东西方 4 个国家的研究人员、工作人员、医院和大学之间的合作关系 非洲、瑞士和美国，拥有 6 个临床中心、4 个初级实验室和约 20 名共同研究人员发言 英语和法语。临床和数据质量核心 (CDQ) 旨在支持标准化 联盟数据严格的数据采集、管理和分析。 CDQ将确保高质量的数据 严格收集，临床测量和实验室测试的评估标准化 站点之间，有效地进行数据协调，并提供高质量的分析数据集 及时生产。 CDQ 核心通过以下方式为这两个项目和试点项目提供支持 发展核心。对科学和能力发展目标的支持确保 联合体项目全面、系统、严谨的数据采集、管理和分析 适当地最大化资源并很有可能产生科学影响。