ETIOLOGY OF SARCOIDOSIS A CASE CONTROL STUDY

本项目的总体目标是支持多中心病例- 结节病潜在致病因素的对照研究的 还将跟踪病例，以获得有关 这种疾病包括疾病进展的危险因素。一 指导委员会将制定一项议定书和业务手册， 将讨论最有希望的假设，以确定 结节病的病因该协议将包括一个全面的 每个参与者的临床表征和标记物的测定 免疫反应。参与银行系统 每个临床中心都需要生物样本。的 临床协调中心将收集、管理和分析数据 从临床中心收集。 临床协调中心将协调方案的编写 和操作手册，管理生物库的后勤工作 系统，负责建立数据录入程序， 管理数据库，负责后勤的指导 委员会和数据与安全监查委员会会议，并执行 最终数据集的统计分析。六年计划是 设想如下：第一阶段（12个月）：合作协议， 将制定业务手册;第二阶段（48个月）：将 涉及病例、患者和招募的招募和随访 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.