Observation Study of Persons with Chronic Hepatitis B Virus infection in North America

 描述（由申请方提供）：慢性B型肝炎（HBV）感染的治疗目标是抑制病毒复制和炎症，以及促进对病毒血症的免疫控制。慢性病毒性肝炎的成功治疗依赖于对肝内免疫成分的了解。先前的研究表明，肝内免疫应答可预测自然病程和治疗结果。肝脏特异性免疫应答（肝内免疫）与慢性肝炎中免疫系统的外周成分（外周血免疫）不一致，可能与肝脏病理学更相关。因此，外周血单核细胞（PBMC）不足以表征肝内和整体相关的免疫反应。目前，肝活检是获取肝组织样本以监测肝内状况的唯一手段。标准肝活检是痛苦的，侵入性的，并且不能以直接观察肝脏状况所需的频率重复。我们建议使用细针穿刺活检（FNAB）作为一种微创手术，在慢性HBV感染的不同疾病和治疗阶段定期监测肝内情况。细针穿刺活检（FNAB）是一种简单快速的程序，通常用于浅表实体瘤或囊肿的取样。FNAB也经常用于跟踪移植器官或组织（肝脏，肾脏）的状况。FNAB已成功用于研究抗HCV和抗HBV免疫应答的肝内组分。使其成为研究肝内环境的合适程序的FNAB的优点是：1）微创; 2）风险最小; 3）可多次应用; 4）良好的样品质量。假设：FNAB可作为一种非侵入性的方法定期使用，以直接调查和监测慢性HBV感染和治疗过程中不同阶段的肝内免疫成分。研究目的：本研究旨在实现这些目标：-评估肝脏的免疫特征-将肝内免疫特征与外周血进行比较-确定肝内免疫细胞特征与疾病的不同阶段和治疗的相关性。这些数据将用于制定疾病和治疗不同阶段的诊断和预测标准。研究设计：年龄在18岁至70岁之间的患者，经筛选并入组至少一项同意并同意FNAB程序的HBRN研究，将被考虑用于本研究。血小板计数或血凝素水平低的患者以及接受抗凝治疗或终末期肾病的患者将被排除。

 DESCRIPTION (provided by applicant): Treatment for chronic hepatitis B infection (HBV) is targeted at suppressing viral replication and inflammation as well as promoting immune control of viremia. Successful treatment of chronic viral hepatitis relies on the understanding of intrahepatic immune components. Previous studies have shown that intrahepatic immune responses are predictive of natural history and treatment outcomes. Liver-specific immune responses (intra-hepatic immunity) do not correspond to the peripheral components of the immune system (peripheral blood immunity) in chronic hepatitis and likely are more relevant to liver pathology. Thus, peripheral blood mononuclear cells (PBMCs) are insufficient to characterize the intrahepatic and overall relevant immune responses. Currently, liver biopsies are the only means for acquiring liver tissue samples for monitoring intrahepatic conditions. Standard liver biopsies are painful, invasive, and cannot be repeated at frequencies that are necessary for direct observation of liver conditions. We are proposing to use fine needle aspiration biopsy (FNAB) as a minimally invasive procedure for regular monitoring of intrahepatic conditions throughout different disease and treatment stages of chronic HBV infection. A fine needle aspiration biopsy (FNAB) is a simple and quick procedure that is regularly used for sampling superficial solid tumors or cysts. FNAB is also routinely applied for following up the conditions of transplanted organs or tissues (liver, kidney). FNAB has been successfully used for studying the intrahepatic components of anti-HCV and anti-HBV immune responses. The advantages of FNAB that make it a suitable procedure for studying intrahepatic environment are: 1) Minimal invasiveness; 2) Minimum risk; 3) Can be applied multiple times; 4) Good sample quality. Hypothesis: FNAB can be used regularly as a non-invasive procedure to directly investigate and monitor the intrahepatic immune components during different stages of chronic HBV infection and treatment. Study Aims: This study aims at achieving these objectives: - Evaluating the immune profile of the liver- Comparing the intrahepatic immune profile to peripheral blood - Determining the association of intrahepatic immunocyte profiles with different stages of the disease and treatment. These data will be used to develop diagnostic and predictive criteria for different stages of the diseases and treatments. Study design: Patients between the ages of 18 and 70 that were screened and enrolled in at least one of HBRN studies that agree and consent to the FNAB procedure will be considered for the study. Patients with low levels of platelet count, or hemoglobulin, and patients under anticoagulation treatment or end- stage renal diseases will be excluded.