Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Data Coordinating Center

非酒精性脂肪性肝炎临床研究网络 (NASH CRN) 数据协调中心的延续

• 批准号: 10251387
• 负责人: James A Tonascia
• 金额: $ 35万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-05-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10251387
• 关键词: Adult; Affect; Ancillary Study; Archives; Biological Markers; Biometry; Cardiovascular system; Cessation of life; Child; Childhood; Cirrhosis; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Network; Cohort Studies; Collaborations; Communication; Control Groups; Data; Data Coordinating Center; Development; Diagnosis; Emerging Technologies; Enrollment; Ensure; Ethics; Fibrosis; Funding; Future; Genomics; Health; Hepatic; Histology; Incidence; Industry; Institutional Review Boards; Lead; Leadership; Liver; Liver Cirrhosis; Liver diseases; Losartan; Malignant Neoplasms; Malignant neoplasm of liver; Measures; Metabolic; Metadata; Methods; Mission; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; North America; Outcome; Pathogenesis; Patients; Phase; Primary carcinoma of the liver cells; Private Sector; Proteomics; Public Health; Publications; Quality Control; Research; Research Design; Research Personnel; Safety; Scientist; Therapeutic Clinical Trial; Translational Research; United States; United States National Institutes of Health; adverse outcome; chronic liver disease; clinical center; clinical implementation; cost; data management; digital imaging; disease natural history; genomic data; improved; innovation; liver transplantation; metabolomics; microbiome research; mortality; multidimensional data; neoplastic; non-alcoholic fatty liver; non-alcoholic fatty liver disease; nonalcoholic steatohepatitis; novel; novel therapeutics; pediatric non-alcoholic fatty liver disease; prevent; programs; repository; response; treatment strategy; treatment trial

Project Summary/Abstract Nonalcoholic fatty liver disease (NAFLD) affects one in three adults and one in five children in North America and is a growing public health issue in the United States and many parts of the world. NAFLD, and especially nonalcoholic steatohepatitis (NASH), may lead to cirrhosis requiring liver transplant, and liver cancer, as well as liver-, cardiovascular-, and cancer-related morbidity and mortality, resulting in increased health burdens and associated costs. The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) has been sponsored by the National Institutes of Health (NIH) since 2002 and has provided important information regarding the natural history and treatment of NAFLD and NASH in adults and children, and has set the stage for translational research focused on the pathogenesis, diagnosis, treatment, and clinical management of these patients. This application is in response to the Limited Competition for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Data Coordinating Center (DCC) (RFA-DK-18-506). Our aims for the continuation in response to the RFA are: 1) To complete the pediatric treatment trial initiated during the previous funding cycle; 2) To develop and conduct a new adult phase 2 treatment trial; 3) To coordinate the concepts, development, vetting, and selection by the Steering Committee and NIDDK of additional clinical trials in adults and children of novel therapeutic strategies; 4) To coordinate and facilitate synergistic partnerships between NASH CRN investigators and expert scientists to use biospecimens, histology, digital imaging, and clinical meta-data to derive novel non-invasive biomarkers and advance the understanding of genomic, proteomic, lipidomic, metabolomic, and microbiomic determinants of the pathogenesis and progression of NASH; 5) To coordinate the development of a natural history cohort study of NAFLD, including both hepatic and non-hepatic outcomes; 6) To coordinate and implement use of a centralized IRB (sIRB) to oversee all future NASH CRN studies. The Data Coordinating Center will provide the NASH CRN with leadership, expertise in biostatistical analysis, study design, data management, multicenter coordination, quality control methods, safety oversight, project support, communication, and organization, and is eager to continue its collaboration with the clinical centers, NIDDK program staff, and private sector partners to complete these important research objectives. The NASH CRN is poised to continue its major impact on the field and directly advance the mission of the National Institutes of Health to improve the health of the public.

项目概要/摘要 非酒精性脂肪肝 (NAFLD) 影响北方三分之一的成年人和五分之一的儿童 在美国和世界许多地区，这是一个日益严重的公共卫生问题。非酒精性脂肪肝病，以及 尤其是非酒精性脂肪性肝炎（NASH），可能会导致肝硬化，需要肝移植，而肝 癌症以及肝癌、心血管和癌症相关的发病率和死亡率，导致 健康负担和相关费用。非酒精性脂肪性肝炎临床研究网络 (NASH CRN）自 2002 年以来一直由美国国立卫生研究院 (NIH) 赞助，并提供了重要的 有关成人和儿童 NAFLD 和 NASH 的自然史和治疗的信息，并已 为专注于发病机制、诊断、治疗和临床的转化研究奠定基础 对这些患者的管理。此申请是为了响应延续的有限竞争 非酒精性脂肪性肝炎临床研究网络 (NASH CRN) 数据协调中心 (DCC) (RFA-DK-18-506)。我们继续响应 RFA 的目标是： 1) 完成儿科 在上一个资助周期内启动的治疗试验； 2) 开发并进行新的成人阶段2 治疗试验； 3) 协调指导委员会的概念、开发、审查和选择 委员会和 NIDDK 在成人和儿童中进行新治疗策略的额外临床试验； 4） 协调和促进 NASH CRN 研究人员和专家科学家之间的协同合作伙伴关系 使用生物样本、组织学、数字成像和临床元数据来衍生新型非侵入性 生物标志物并促进对基因组、蛋白质组、脂质组、代谢组学和 NASH 发病机制和进展的微生物决定因素； 5）协调发展 NAFLD 自然史队列研究，包括肝脏和非肝脏结果； 6) 到 协调和实施集中 IRB (sIRB) 的使用，以监督所有未来的 NASH CRN 研究。这 数据协调中心将为 NASH CRN 提供生物统计分析方面的领导力和专业知识， 研究设计、数据管理、多中心协调、质量控制方法、安全监督、项目 支持、沟通和组织，并渴望继续与临床合作 中心、NIDDK 项目工作人员和私营部门合作伙伴来完成这些重要的研究目标。 NASH CRN 准备继续在该领域发挥重大影响，并直接推进 NASH 的使命 美国国立卫生研究院致力于改善公众的健康。