CASCADE Coordinating Center

CASCADE协调中心

• 批准号: 10544439
• 负责人: KyungMann Kim
• 金额: $ 144.71万
• 依托单位: FRONTIER SCI & TECHNOLOGY RSCH FDN, INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-07 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10544439
• 关键词: Acquired Immunodeficiency Syndrome; Area; Biometry; Cervical; Cervical Cancer Screening; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical effectiveness; Data; Data Analyses; Data Reporting; Detection; Division of Cancer Prevention; Effectiveness of Interventions; Emergency Situation; Environment; Goals; HIV; Health Services Accessibility; Human Papillomavirus; Incidence; Informatics; Information Technology; Infrastructure; Intervention; Leadership; Lesion; Logistics; Malignant neoplasm of cervix uteri; Measurement; Methodology; Phase; Positioning Attribute; Pragmatic clinical trial; Protocols documentation; Recurrence; Research; Resource-limited setting; Resources; Risk; Site; Specific qualifier value; Time; United States; Woman; antiretroviral therapy; base; cancer invasiveness; cancer prevention; cervical cancer prevention; clinical research site; cost; cost effective; data management; design; effectiveness evaluation; effectiveness implementation design; effectiveness implementation study; health disparity; high risk; implementation strategy; improved; innovation; low and middle-income countries; multidisciplinary; operation; premalignant; prevention clinical trial; programs; protocol development; scale up; screening; screening services; support network; treatment services; uptake; virtual

Project Summary/Abstract Women living with HIV (WLWH) have a higher risk for acquisition, persistence, and progression of cervical human papillomavirus (HPV) to precancerous lesions, which, in the absence of effective screening and treatment services, can progress to invasive cancer at five-to-six times higher rates than in women without HIV. The massive global mobilization of humanitarian resources spanning over the past couple of decades, through initiatives such as the US President's Emergency Plan for AIDS Relief (PEPFAR), has resulted in millions of WLWH in low- and middle-income countries (LMICs) now accessing affordable antiretroviral therapy and consequently living longer lives. Yet, their risk for cervical cancer continues unabated since effective screening and pre-cancer treatment services remain unavailable in most LMICs. The HIV/Cervical Cancer Prevention “CASCADE” Clinical Trials Network plans to conduct pragmatic clinical trials evaluating the effectiveness of clinically proven interventions to optimize the cervical cancer screening, management, and pre-cancer treatment cascade for WLWH. These clinical trials will be conducted in intended- use environments in resource-constrained settings in LMICs and in regions with health disparities in the United States. The CASCADE Network will have four major scientific focus areas: increasing screening uptake, improving management of screen positives, facilitating pre-cancer treatment access, and optimizing pre-cancer treatment for cervical cancer prevention in WLWH. The CASCADE Network clinical trials will focus on the measurement of the clinical effectiveness of interventions in intended use settings while gathering crucial information informing the implementation and scale-up of such interventions across the cascade of screening and pre-cancer treatment for WLWH. Such hybrid effectiveness-implementation designs will primarily focus on clinical effectiveness endpoints such as HPV positivity rates and/or pre-cancer detection/incidence/recurrence rates and will secondarily gather data on implementation-informing aspects such as costs, acceptability, and intervention fidelity while studying implementation strategy. To support the CASCADE Clinical Trials Network in partnership with the NCI's Division of Cancer Prevention, CASCADE Research Bases and CASCADE Clinical Sites, the CASCADE Network Coordinating Center will (i) provide overall network coordination and facilitate scientific review of network clinical trial concepts and protocols, (ii) provide centralized support for data management for network clinical trials, and (iii) conduct independent risk-appropriate auditing of network clinical trials. The CASCADE Network Coordinating Center will serve as the organizational and coordination hub for the CASCADE Network and provide multi-disciplinary expertise in program and operations management, clinical research informatics/information technology, and clinical trials auditing.

项目概要/摘要 感染艾滋病毒 (WLWH) 的女性患宫颈癌、持续存在和进展的风险更高 人乳头瘤病毒 (HPV) 会导致癌前病变，在缺乏有效筛查和预防的情况下， 接受治疗服务的女性进展为浸润性癌症的比率比未接受治疗的女性高出五到六倍 过去几十年全球大规模调动人道主义资源， 通过美国总统艾滋病紧急救援计划 (PEPFAR) 等举措， 低收入和中等收入国家 (LMIC) 的数百万 WLWH 现在正在获得负担得起的抗逆转录病毒治疗 然而，自生效以来，她们患宫颈癌的风险仍然有增无减。 大多数中低收入国家仍然无法获得筛查和癌前治疗服务。 HIV/宫颈癌预防“CASCADE”临床试验网络计划开展务实临床 评估经过临床验证的干预措施的有效性的试验，以优化宫颈癌筛查， WLWH 的管理和癌前治疗级联这些临床试验将按预期进行。 在中低收入国家资源有限的环境中以及在美国存在健康差异的地区使用环境 CASCADE 网络将有四个主要科学重点领域：提高筛查率、 改善筛查阳性的管理，促进癌前治疗的可及性，并优化癌前治疗 CASCADE 网络临床试验将重点关注 WLWH 中预防宫颈癌的治疗。 衡量干预措施在预期使用环境中的临床有效性，同时收集关键信息 为在一系列筛查中实施和扩大此类干预措施提供信息 这种混合有效性实施设计将主要集中于 WLWH 的癌症前治疗。 临床有效性终点，例如 HPV 阳性率和/或癌前检测/发病率/复发率 率，并其次收集有关实施信息方面的数据，例如成本、可接受性和 研究策略实施时的干预保真度。 为了与 NCI 癌症预防部门合作支持 CASCADE 临床试验网络， CASCADE 研究基地和 CASCADE 临床中心，CASCADE 网络协调中心将 (i) 提供整体网络协调并促进网络临床试验概念的科学审查和 协议，(ii) 为网络临床试验的数据管理提供集中支持，以及 (iii) 进行 CASCADE 网络协调中心的独立风险适当审核。 将作为 CASCADE 网络的组织和协调中心，并提供多学科 项目和运营管理、临床研究信息学/信息技术方面的专业知识，以及 临床试验审核。