CORE--CLINICAL

临床核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 支持中心内的各个协议，促进交互 调查人员之间的联系，并为 临床研究项目的制定、执行和数据分析。 临床方案被设计为接近最好的可用方案 特发性肺疾病的诊断、评估和治疗策略 纤维化和结节病。 具体目标是： 1.管理涉及特发性疾病患者的临床研究 肺纤维化与结节病 *身份符合资格的病人 *协调来自纤维化肺部疾病网络的患者流 医生前往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 *记分胸片和高分辨率计算机体层摄影术 (HRCT) *根据HRCT结果选择活检点 *与UMMC和Fibrotic的胸外科医生沟通活检地点 肺病网络网站 *管理使用强的松和强的松/硫唑嘌呤的门诊患者和 甲氨蝶呤 *协调使用强的松的患者的门诊管理， 强的松/硫唑嘌呤和甲氨蝶呤治疗 纤维性肺疾病网络 2.为个别调查人员采购组织和细胞 *进行支气管肺泡灌洗(BAL)和经支气管镜活检(TBBx) IPF和结节病患者及正常志愿者的BAL *从UMMC收集开放的肺活检标本 *协调向病人采购开胸肺活检标本 在纤维化肺疾病网络中被内科医生识别 *协调运送来自纤维性疾病的开放肺活检标本 从肺部疾病网络到组织核心 *从正在进行尸检或 IPF以外原因的开胸手术 3.为个别调查人员提供资料管理服务 *组织和管理临床数据库 *就研究设计、样本容量计算和选择提供意见 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