Core--Clinical

（申请人摘要）临床核心的总体目标是 提供所需的人员、物质资源和组织， 为项目I生成临床数据库和生物样本， 5.临床中心将负责1）设计、实施和 在SCOR内执行临床研究方案，2）进行互动 在不同项目的研究人员之间，3）为了收集数据， 管理和统计分析。拟议的临床方案包括 诊断和治疗特发性肺动脉高压最新方法 纤维化JPF）和评估其对治疗的反应。具体目标是 如下所示： 执行涉及特发性肺动脉高压患者的临床方案 纤维化 从UCLA及其网络附属机构招募符合条件的IPF患者， 洛杉矶地区获取并审查初步评估的预筛选数据 研究资格。 获得知情同意书，收集临床数据并进行肺功能检查 测试 获取胸部X线片和胸部高分辨率计算机化片并评分 确定是否有资格进入导入期（泼尼松 治疗3个月） 在指定的时间点重复进行临床、影像学和生理学评估 间隔 确定随机化的合格性，并将合格患者随机分配至 治疗期 管理接受研究治疗方案（干扰素-γ）的随机化患者 [IFN-γ]加低剂量泼尼松与硫唑嘌呤[AZAI加低剂量泼尼松] 泼尼松），监测毒性，并在3- 使用CRP评估工具的月间隔 获取肺组织和支气管肺泡灌洗液和细胞。 处理和运输IPF患者的肺活检标本至组织 病理学核心 在随机化时以及术后6个月和12个月进行纤维支气管镜检查 研究治疗开始时和复发时， IFN-γ或AZA停药后的疾病。处理和转移 支气管肺泡灌洗液和细胞以及经支气管活检标本， 组织病理学核心

(Applicant's Abstract) The overall objective of the Clinical Core is to provide the personnel, physical resources and organization required to generate the clinical database and biologic specimens for projects I through 5. The Clinical Core will be responsible 1) for the design, implementation and execution of clinical research protocols within the SCOR, 2) for interactions between investigators in the various projects and 3) for data collection, data management and statistical analysis. A proposed clinical protocol incorporates state-of-the-art methods for diagnosis and treatment of idiopathic pulmonary fibrosis JPF) and assessment of its response to therapy. The specific aims are as follows: To execute clinical protocols involving patients with idiopathic pulmonary fibrosis. Recruit eligible patients with IPF from UCLA and its network affiliates in the Los Angeles area Acquire and review pre-screening data for initial assessment of study eligibility. Obtain informed consent, collect clinical data and perform pulmonary function testing Obtain and score chest radiographs and thoracic high resolution computerized tomographs Determine eligibility for enrollment into run-in phase (prednisone therapy for 3 months) Repeat clinical, radiographic and physiologic assessments at specified intervals Determine eligibility for randomization and randomize eligible patients into the treatment phase Manage randomized patients on study treatment regimens (interferon -gamma [IFN-gamma] plus low-dose prednisone vs. azathioprine [AZAI plus low-dose prednisone), monitor toxicity and formally assess response to therapy at 3- month intervals using CRP assessment tools To procure lung tissue and bronchoalveolar lavage fluid and cells. Handle and transport lung biopsy specimens from IPF patients to the Tissue Pathology Core Perform fiberoptic bronchoscopy at randomization and at 6 and 12 months after initiation of study treatment and at the time of relapse in patients whose disease worsens after discontinuation of IFN-gamma or AZA. Handle and transfer bronchoalveolar lavage fluid and cells and transbronchial biopsy specimens to the Tissue Pathology Core.