Chronic Kidney Diseases of Uncertain Etiology (CKDu) in Agricultural Communities (CURE) Research Consortium - SDCC

项目概要/摘要 世界各地越来越多的不同地区报告慢性肾病发病率不断上升 病因不确定或未知的疾病（CKDu），一种无法归因于传统方法的危及生命的疾病 慢性肾脏病的危险因素。然而，CKDu 的病因仍不清楚，且缺乏有关 CKDu 的数据 进展、生物学表现、遗传决定因素和可能解释区域性的危险因素 变化。为了应对这些挑战，美国国立卫生研究院成立了慢性肾脏病研究中心 农业社区病因不明疾病 (CKDu) (CURE) 研究联盟。的 联盟将制定一项统一的研究方案，可在多个流行地区实施，以 了解 CKDu 的病因和疾病进展，并确定潜在的治疗靶点和 公共卫生干预措施。 RTI International 和波士顿大学以及我们来自哈佛大学的合作伙伴 大学、尼加拉瓜国立自治大学、科罗拉多大学和斯坦福大学， 提议建立CURE研究联盟科学数据协调中心（SDCC）。 SDCC 将提供领导力、基础设施和工具来联合现场流行病学站点、肾脏科学核心、 人类健康暴露分析资源和 NIH 通过促进共识形成一个有凝聚力的整体 和协作决策。 SDCC 在制定共同研究议程方面的作用对于 CURE 研究联盟实施伦理流行病学研究设计的能力；常见的 数据收集以及生物和环境评估的方法；数据分析的最佳实践 和传播；和辅助研究。具体来说，SDCC 将支持该研究 联盟通过实现以下目标：（1）阐明 CKDu 可能的多因素病因 通过将经典病例对照研究与纵向研究相结合，在流行地区发生和进展 评估病例以评估疾病进展的因素和控制以捕获 CKDu 的发展情况； (2) 通过提供科学领导，促进共识的建立并促进协作与协调， 数据科学和强大的分析方法以及通信、后勤和运营方面的专业知识 支持； (3) 通过提供健全的研究框架来提高联盟的研究效率、生产力和科学严谨性 研究监测和监督并建立有效的数据和样本管理系统 相关技术和数据可视化工具。与多学科的联合研究团队一起， SDCC 的多名 PI，Jill Lebov 博士（联系 PI）、Marie Gantz 博士和 Daniel Brooks 博士带来了 需要联盟协调、项目管理方面的科学和组织能力， 流行病学、生物统计学、数据科学、肾脏病学和肾脏疾病研究、环境和 在资源有限的环境中开展国际研究的职业健康、遗传学和伦理行为 有效管理 SDCC、CURE 研究联盟和 CURE 研究的活动。

PROJECT SUMMARY/ABSTRACT A growing number of geographically diverse regions around the world report increasing rates of chronic kidney disease of uncertain or unknown etiology (CKDu), a life-threatening condition not attributable to traditional chronic kidney disease risk factors. Yet, the etiology of CKDu remains unclear and data are lacking on CKDu progression, biological manifestations, genetic determinants, and risk factors that may explain regional variations. To address these challenges, the National Institutes of Health has formed the Chronic Kidney Diseases of UnceRtain Etiology (CKDu) in Agricultural Communities (CURE) Research Consortium. The Consortium will develop a harmonized study protocol that can be implemented in multiple endemic regions to understand the etiologies of CKDu and disease progression and to identify potential therapeutic targets and public health interventions. RTI International and Boston University along with our partners from Harvard University, National Autonomous University of Nicaragua, University of Colorado, and Stanford University, propose to establish the CURE Research Consortium Scientific Data Coordinating Center (SDCC). The SDCC will provide the leadership, infrastructure, and tools to unite the Field Epidemiology Sites, Renal Science Core, Human Health Exposure Analysis Resource, and NIH into a cohesive whole by promoting consensus building and collaborative decision making. The SDCC's role in cultivating a common research agenda is crucial to the CURE Research Consortium's ability to implement ethical epidemiology research designs; common approaches for data collection, and biological and environmental assessments; best practices for data analysis and dissemination; and ancillary research studies. Specifically, the SDCC will support the Research Consortium by accomplishing the following aims: (1) elucidate the likely multifactorial etiologies of CKDu development and progression in endemic regions by integrating a classic case-control study with longitudinal assessments of cases to assess factors for disease progression and controls to capture CKDu development; (2) promote consensus building and foster collaboration and coordination by providing scientific leadership, expertise in data science and robust analytical methods, and communication, logistical, and operational support; and (3) enhance Consortium research efficiency, productivity, and scientific rigor by providing sound study monitoring and oversight and establishing efficient data and specimen management systems using relevant technology and data visualization tools. Together with a multidisciplinary team of Co-investigators, the SDCC multiple PIs, Jill Lebov, PhD (contact PI), Marie Gantz, PhD, and Daniel Brooks, PhD, bring the required scientific and organizational capabilities in Consortium coordination, project management, epidemiology, biostatistics, data science, nephrology and kidney disease research, environmental and occupational health, genetics, and ethical conduct of international research in resource-limited settings to effectively manage the activities of the SDCC, the CURE Research Consortium, and the CURE Study.