CORE--CLINICAL

临床中心的使命是提供人员，设施， 以及生成临床数据库所需的组织结构 以及项目1、2和3的患者样本。这些资源将 支持中心内的个别协议，促进互动 研究人员之间，并提供一个有凝聚力的框架， 临床研究项目的制定、执行和数据分析。 临床方案旨在接近现有的最佳方案 特发性肺动脉高压的诊断、评估和治疗策略 纤维化和结节病。 具体目标是： 1.管理涉及特发性乳腺癌患者的临床研究 肺纤维化和结节病 * 识别合格患者 * 协调来自纤维化肺病网络的患者流 医生到UMMC进行初步评估 * 获得知情同意并招募患者 * 收集临床数据 * 进行生理测试 * 胸部X线片和高分辨率计算机断层扫描评分 （HRCT） * 根据HRCT结果选择活检部位 * 与UMMC和Fibrotic的胸外科医生沟通活检部位 肺部疾病网络网站 * 管理接受泼尼松和泼尼松/硫唑嘌呤的门诊患者， 甲氨 * 协调泼尼松患者的门诊管理， 泼尼松/硫唑嘌呤和甲氨蝶呤治疗后， 纤维化肺病网络 2.为个别研究者采购组织和细胞 * 进行支气管肺泡灌洗（BAL）和经支气管活检（TBBx） IPF和结节病患者以及正常志愿者的BAL * 从UMMC采集开放性肺活检标本 * 协调患者开放肺活检标本的采购 肺纤维化疾病网络中的医生确定 * 协调纤维化患者开放性肺活检标本的运送 肺部疾病网络到组织核心 * 从进行尸检的患者身上获取肺组织，或 因IPF以外原因行开胸术 3.为个体研究者提供数据管理服务 * 组织和管理临床数据库 * 就研究设计、样本量计算和选择提供建议 适当的结果变量 * 协助统计应用和数据分析

The mission of the Clinical Core is to provide the personnel, facilities, and organizational structure necessary to generate the clinical database and patient specimens for projects 1, 2 and 3. These resources will support individual protocols within the Center, facilitate interactions between investigators, and provide a cohesive framework for the formulation, execution, and data analysis of clinical research projects. The clinical protocol is designed to approximate the best available strategies for diagnostic assessment and therapy of idiopathic pulmonary fibrosis and sarcoidosis. The specific aims are: 1. To manage the clinical studies involving patients with idiopathic pulmonary fibrosis and sarcoidosis * Identity eligible patients * Coordinate patient flow from the Fibrotic Lung Disease Network physicians to UMMC for initial evaluation * Obtain informed consent and enroll patients * Collect clinical data * Perform physiologic testing * Score chest roentgenograms and high resolution computerized tomography (HRCT) * Select the biopsy site based on HRCT findings * Communicate biopsy sites to thoracic surgeons at UMMC and at Fibrotic Lung Disease Network sites * Manage outpatients on prednisone and prednisone/azathioprine and methotrexate * Coordinate outpatient management of patients on prednisone, prednisone/azathioprine and methotrexate therapy being followed in the Fibrotic Lung Disease Network 2. To procure tissues and cells for individual investigators * Perform bronchoalveolar lavage (BAL) and transbronchial biopsies (TBBx) in IPF and sarcoidosis patients and BAL in normal volunteers * Collect open lung biopsy specimens from UMMC * Coordinate the procurement of open lung biopsy specimens from patients identified by physicians in the Fibrotic Lung Disease Network * Coordinate the delivery of open lung biopsy specimens from Fibrotic Lung Disease Network to Tissue Core * Procure pulmonary tissues from patients undergoing autopsy or thoracotomy for reasons other than IPF 3. To provide data management services to individual investigators * Organize and manage the clinical data base * Advise on study design, sample size calculations and selection of appropriate outcome variables * Assist with statistical applications and data analysis