Liver Cirrhosis Network: Scientific and Data Coordination Center

肝硬化网络：科学和数据协调中心

• 批准号: 10309196
• 负责人: Jody D. Ciolino
• 金额: $ 239万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-28 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10309196
• 关键词: Adrenergic beta-Antagonists; Alcohol dependence; Ascites; Biometry; Blood Vessels; Body Weight decreased; Budgets; Case Report Form; Cause of Death; Cell physiology; Charge; Chronic Hepatitis C; Cirrhosis; Clinical; Clinical Trials Design; Cohort Studies; Communication; Confusion; Data; Data Analyses; Data Coordinating Center; Development; Disease; Disease Progression; Endothelial Cells; Enzymes; Event; Faculty; Fatigue; Fibrosis; Gastrointestinal Hemorrhage; Hemorrhage; Hepatic; Hepatic Encephalopathy; Human Resources; Icterus; Image; Impairment; Inflammation; Institutional Review Boards; Intervention; Investigation; Kidney; Laboratories; Lead; Leadership; Left; Life Style; Link; Liver; Liver Cirrhosis; Liver diseases; Longitudinal cohort; Malignant Neoplasms; Manuals; Medical; Meta-Analysis; Methodology; Modification; Monitor; Morbidity - disease rate; Multi-site clinical study; Multicenter Studies; National Institute of Diabetes and Digestive and Kidney Diseases; Obesity; Operative Surgical Procedures; Organ; Outcome; Oxidative Stress; Oxidoreductase; Patients; Positioning Attribute; Preventive Medicine; Primary carcinoma of the liver cells; Prognosis; Prospective cohort; Proteins; Protocols documentation; Provider; Public Health; Randomized; Randomized Controlled Trials; Reporting; Reproducibility; Research; Research Design; Research Personnel; Resources; Risk; Role; Safety; Sampling; Site; Social Sciences; Statistical Data Interpretation; Symptoms; Training; Transplantation; United States; Universities; Work; absorption; central database; clinical center; cost; curative treatments; data quality; design; disease natural history; double-blind placebo controlled trial; experience; gastrointestinal; improved; infection risk; innovation; liver transplantation; member; method development; mid-career faculty; mortality; multiple data types; nonalcoholic steatohepatitis; novel; nutrition; operation; prevent; professor; prospective; quality assurance; symptom treatment; transplant centers; treatment strategy

PROJECT SUMMARY Liver cirrhosis poses a significant public health burden in the United States (US) as it is associated with substantial morbidity, mortality and cost. An estimated one-third of patients develop decompensating events such as gastrointestinal variceal bleeding, ascites, hepatic encephalopathy (HE), jaundice, and renal impairment. Further, these poor outcomes are also associated with development of hepatocellular carcinoma (HCC) in the cirrhotic liver, the ninth leading cause of death among cancers within the US. While transplantation is a curative treatment for cirrhosis, patients are often ineligible for transplantation due to lack of available organs and additional risks involved. Thus, patients and providers frequently focus on symptomatic treatment options such as lifestyle/nutrition modifications to initiate weight loss and optimize protein absorption, nonselective beta- blockers to reduce the risk of gastrointestinal bleeding, and treatment for HE to improve confusion. A recent meta-analysis suggests statin therapy as a promising treatment for cirrhosis as statins tend to decrease oxidative stress and inflammation and increase endothelial cell function, with downstream effects including reduction of hepatic inflammation, fibrosis, and vascular tone. Although this review represents over 120 thousand patients, true efficacy data in the setting of a randomized controlled trial (RCT) are presently limited to just four RCTs from outside of the US, representing less than 300 patients with cirrhosis. To better understand the natural history of the disease and also to further evaluate the use of statins in the treatment of cirrhosis, the Liver Cirrhosis Network (LCN), consisting of up to 10 clinical centers (CCs) and one Scientific and Data Coordination Center (SDCC) will be charged with developing (a) a prospective cohort and (b) an RCT to evaluate statin efficacy in patients with cirrhosis. Northwestern University Data Analysis and Coordinating Center (NUDACC) and its partners propose to serve as the SDCC--the central scientific and leadership core for the LCN--coordinating all operational and data-related activities using cutting-edge resources for study design, planning and conduct, ongoing monitoring, and statistical analyses. NUDACC unites an interdisciplinary team with wide-ranging experience including collaborative and methodologic biostatisticians, hepatologists, data managers, project managers, and multiple supporting study staff. Together we propose to collaborate with the LCN to lead the design, conduct, coordination, oversight, management, administration, analyses, and dissemination for the LCN-related studies.

项目摘要 肝肝硬化在美国（美国）造成了巨大的公共卫生负担 大量发病率，死亡率和成本。估计有三分之一的患者发展为代偿事件 例如胃肠道静脉曲张出血，腹水，肝脑病（HE），黄疸和肾功能障碍。 此外，这些差的结果也与肝细胞癌（HCC）的发展有关 肝硬化肝，美国境内癌症中第九次死亡原因。而移植是一种治愈性 肝硬化治疗，由于缺乏可用器官和 涉及其他风险。因此，患者和提供者经常专注于有症状的治疗选择 随着生活方式/营养修饰以启动体重减轻并优化蛋白质吸收，非选择性β- 阻止者降低胃肠道出血的风险，并治疗HE以改善混乱。最近 荟萃分析认为他汀类药物治疗是肝硬化的一种有希望的治疗方法，因为他汀类药物倾向于降低氧化。 压力和炎症并增加内皮细胞功能，下游影响包括减少 肝炎，纤维化和血管张力。尽管这篇评论代表了超过1.2万名患者 在随机对照试验（RCT）设置中的真实疗效数据目前仅限于四个RCT 在美国以外，代表不到300例肝硬化患者。 更好地了解疾病的自然史，并进一步评估他汀类药物在 肝硬化的治疗，肝硬化网络（LCN），最多10个临床中心（CC）和一个组成 科学和数据协调中心（SDCC）将负责开发（a）潜在的队列和 （b）评估肝硬化患者他汀类药物疗效的RCT。西北大学数据分析和 协调中心（NUDACC）及其合作伙伴建议用作SDCC - 中心科学和 LCN的领导力核心 - 协调所有运营和数据相关的活动，使用尖端资源 用于研究设计，计划和行为，正在进行的监测和统计分析。 nudacc unites an 跨学科团队拥有广泛的经验，包括合作和方法论生物统计学家， 肝病学家，数据经理，项目经理和多个支持学习人员。我们一起建议 与LCN合作领导设计，行为，协调，监督，管理，管理， 分析和与LCN相关研究的传播。