CORE--CLINICAL

(申请人摘要)临床核心的使命是提供 所需的人员、设施和组织结构 项目6、2和7的临床数据库和患者样本。这些 资源将支持中心内的各个协议，促进 调查人员之间的互动，并为 临床研究项目的制定、执行和数据分析。这个 临床方案的设计是为了接近最佳可用的策略 用于特发性间质亚型的诊断评估和治疗 肺炎(11P)，包括特发性肺纤维化(通常为间质性 肺炎(UIP)和非特异性间质性肺炎(NSIP)。具体的 目标是： 管理涉及UIP和NSIP患者的临床研究，包括： (A)确定符合条件的患者并协调来自纤维化的患者流动 肺部疾病网络(FLDN)医生向密歇根大学健康学院 初步评估系统(UN4HS) (B)征得知情同意、招募病人、收集临床数据 (生理检查、记分胸片和高分辨率 计算机断层扫描) (C)根据HRCT检查结果选择活检点，并将其传达给 UMHS和FLDN站点的胸外科医生；协调解释 组织学，由合作的病理学家提供的样本 (D)管理使用强的松、强的松/硫唑嘌呤和齐留通的门诊病人 UMBS或FLDN 为个别调查人员采购组织和细胞，包括： (A)在以下地点进行支气管肺泡灌洗和经支气管活检 适当的时间点 (B)协调在LTMHS或在LTMHS采购肺活检标本 FLDN并将标本交付给UNIHS的适当SCOR调查员 向个人调查员提供数据管理服务，包括： (A)组织和管理临床数据库，就研究设计提供咨询， 样本量计算和适当结果变量的选择 (B)协助统计应用和数据分析。

(Applicant's Abstract) 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 6, 2 and 7. 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 protocols are designed to approximate the best available strategies for diagnostic assessment and therapy for subsets of idiopathic interstitial pneumonias (11P), including idiopathic pulmonary fibrosis (usual interstitial pneumonia, UIP) and nonspecific interstitial pneumonia (NSIP). The specific aims are to: Manage the clinical studies involving patients with UIP and NSIP including: (a) Identify eligible patients and coordinate patient flow from the Fibrotic Lung Disease Network (FLDN) physicians to the University of Michigan Health System (UN4HS) for initial evaluation (b) Obtain informed consent, enroll patients, collect clinical data (physiologic testing, scoring chest roentgenograms and high resolution computed tomography) (c) Select the biopsy site based on HRCT findings, communicate this to thoracic surgeons at the UMHS and at FLDN sites; coordinate the interpretation of histologic, samples by collaborating pathologists (d) Manage outpatients on prednisone, prednisone/azathiopnine and zileuton at UMBS or the FLDN Procure Tissues and cells for individual investigators including: (a) Performing bronchoalveolar lavage and transbronchial biopsies at appropriate time points (b) Coordinate procurement of surgical lung biopsy specimens at LTMHS or at the FLDN and deliver specimens to appropriate SCOR investigator at the UNIHS Provide data management services to individual investigators including: (a) Organizing and managing the clinical database, advisino on study design, sample size calculation and selection of appropriate outcome variables (b) Assisting with statistical applications and data analysis.