Clinical Core

临床核心

• 批准号: 7013919
• 负责人: Nezam Hassan Afdahl
• 金额: $ 3.65万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-06-30 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7013919
• 关键词: HIV infections; biomedical facility; biopsy; chronic disease /disorder; clinical research; cooperative study; disease /disorder classification; hepatitis C; hepatitis C virus; human subject; liver cirrhosis; liver transplantation; medical outreach /case finding; pathologic process; pathology; postoperative complications; relapse /recurrence; sample collection; schistosomiasis; tissue resource /registry

The natural history of chronic HCV infection is very variable and retrospective studies have identified both slow progressors who take 40 years to develop cirrhosis and rapid progressors who may develop advanced fibrosis in as little as 10 - 20 years. The underlying pathophysiological mechanisms associated with disease progression are poorly understood and represent the central focus of this HCV Center. We will study cohorts of patients with variable rates of disease progression. The Clinical Center for HCV disease progression will provide liver tissues, specimens, clinical expertise, biostatistics and a pathology core to interact with the basic Investigators in this HCV Center proposal. The clinical center will utilize both existing cohorts and develop novel cohorts of patients with either slow or fast disease progression to study the underlying immunological, virological and metabolic factors associated with progression of liver fibrosis. In particular we will develop: 1) the Infrastructure for clinical investigation into mechanisms of disease progression and fibrosis in patients with HCV 2) Evaluation of 4 distinct cohorts of patients who have variable rates of fibrosis progression: A) Patients with HCV naive to treatment representing a control group of predominantly slow progressors B) Patients with HCV and Schistosomiasis who rapidly develop cirrhosis C) Patients with HIV/HCV; a subset of whom are immunocompromised with low CD4 counts and may progress more rapidly D) Patients post liver transplant who have recurrent HCV These studies may help identify the mechanism of fibrosis progression and lead to rational use of reources to identify and treat patients at higher risk of disease progression.

慢性HCV感染的自然历史非常可变，回顾性研究已经确定了慢速进步者，他们需要40年的时间来发展肝硬化和快速进步者，他们可能在10-20年内可能会发展晚期纤维化。与疾病进展相关的潜在病理生理机制知之甚少，代表了该HCV中心的中心重点。我们将研究具有疾病进展率变化的患者人群。 HCV疾病进展的临床中心将提供肝组织，标本，临床专业知识，生物统计学和病理核心，以与 此HCV中心提案中的基本研究人员。临床中心将同时利用现有的队列，并开发出慢速或快速疾病进展的新型患者，以研究与肝纤维化进展相关的潜在免疫，病毒学和代谢因素。特别是我们将发展：1）HCV患者疾病进展和纤维化机制的临床研究基础设施 2）评估4个不同的纤维化进展率变化率的患者队列的评估： a）HCV患者天真治疗的患者代表对照组的主要速度慢慢b）迅速发展为肝硬化的HCV和血吸虫病患者 c）患有HIV/HCV的患者；其中一个子集以低CD4计数对免疫功能低下，可能会更快地进展d）肝移植后患者复发性HCV 这些研究可能有助于确定纤维化进展的机制，并导致对鉴定和治疗疾病进展风险更高的患者的合理使用。