Core--Clinical

(申请人摘要)临床核心的总体目标是 提供所需的人员、物力和组织 为项目I至项目生成临床数据库和生物标本 5.临床核心将负责1)设计、实施和 在SCOR中执行临床研究方案，2)相互作用 在各种项目中的调查人员之间以及3)数据收集、数据 管理和统计分析。一项拟议的临床方案纳入了 特发性肺疾病的最新诊断和治疗方法 纤维化JPF)和对其治疗反应的评估。具体目标是 详情如下： 执行涉及特发性肺病患者的临床方案 纤维化症。 从加州大学洛杉矶分校及其网络附属公司招募符合条件的IPF患者 洛杉矶地区获取和审查初步评估的预筛查数据 学习资格。 征得知情同意，收集临床数据，并进行肺功能检查 测试 获得胸部X光片和胸部高分辨率计算机化评分 体层摄影术确定进入磨合阶段(泼尼松)的登记资格 治疗3个月) 在指定的时间重复临床、放射和生理评估 间隔时间 确定随机分组的资格，并将符合条件的患者随机分配到 治疗阶段 管理随机患者的研究治疗方案(干扰素-伽马 [干扰素-γ]加小剂量泼尼松与硫唑嘌呤[阿赛加小剂量 强的松)，监测毒性，并正式评估治疗反应3- 使用CRP评估工具的月份间隔 获取肺组织和支气管肺泡灌洗液及细胞。 处理和运送IPF患者的肺活检标本到组织 病理学核心 随机、6个月和12个月后进行纤维支气管镜检查 以下患者的研究治疗开始时间和复发时间 停用干扰素-γ或AZA后，病情会恶化。办理和转接 支气管肺泡灌洗液和细胞及经支气管镜活检标本 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.