ETIOLOGY OF SARCOIDOSIS A CASE CONTROL STUDY

该计划的总体目标是支持多中心案例- 结节病潜在致病因素对照研究。这个 还将跟踪案例，以获得有关自然历史的信息 本病包括疾病进展的危险因素。一个 指导委员会将制定一项协议和操作手册， 将解决最有希望的假设，以确定 结节病病因(S)。该议定书将包括一项全面的 每位受试者的临床特征和标志物的测定 免疫反应性。参与银行体系 每个临床中心都需要生物标本。这个 临床协调中心将收集、管理和分析数据 从临床中心收集的。 临床协调中心将协调协议的编写 和操作手册，管理生物银行的物流 系统，负责建立数据录入程序和 管理数据库，负责转向的后勤工作 委员会、数据和安全监测委员会会议，并履行 对最终数据集进行统计分析。六年的时间表是 设想如下：第一阶段(12个月)：协作议定书和 将编制操作手册；第二阶段(48个月)：将 参与招募和跟进病例、患者和招募 和对照受试者的访谈，以及第三阶段(12个月)：将 涉及数据分析。

The overall objective of this program is to support a multicenter case- control study on the potential etiologic factors for sarcoidosis. The cases will also be followed to gain information on the natural history of this disease including risk factors for progression of disease. A steering committee will develop a protocol and manual of operations which will address the most promising hypotheses to be pursued to identify the cause(s) of sarcoidosis. The protocol will include a comprehensive clinical characterization of each participant and determination of markers of immune responsiveness. Participation in a system for banking biological specimens will be required of each clinical center. The clinical coordinating center will collect, manage and analyze the data collected from the clinical centers. The clinical coordinating center will coordinate writing of the protocol and manual of operations, manage the logistics of the biological banking system, be responsible for setting up the data entry procedures and managing the database, be responsible for the logistics of the steering committee and Data and Safety Monitoring Board meetings, and perform the statistical analysis of the final data set. A six year schedule is envisioned as follows: Phase I (12 Months): A collaborative protocol and manual of operations will be developed; Phase II (48 Months): will involve the recruitment and follow-up of cases, patients and recruitment and interviewing of control subjects, and Phase III (12 Months): will involve data analysis.