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。案例 也将被跟踪以获得关于这一自然历史的信息 疾病包括疾病进展的风险因素。方向盘 委员会将制定一项议定书和操作手册，以 提出最有希望的假设，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。承包商将参与一个系统， 保存生物标本。 将建立临床协调中心，收集、管理和 分析临床中心的数据。据估计， 总研究人群将包括720例病例和1,440名对照。它 据估计，每个临床中心都将招收、面试和检查 72例结节病患者(21岁或以上)，登记，面试 从144名匹配的对照组受试者身上采集一份血液样本 一年期间。临床中心将测试具体的假设，包括 危险因素、家族聚集性及其病因的遗传学 2)描述结节病的自然病史。A六年 时间表设想如下：第一阶段(12个月)：协作 将制定操作规程和手册；第二阶段(48个月)： 将涉及招募和跟进患者以及招募和 访谈对照受试者，以及第三阶段(12个月)：将包括 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. 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. The contractor will participate in a system for banking biological specimens. A clinical coordinating center will be established to collect, manage and analyze the data from the clinical centers. It is estimated that the total study population will consist of 720 cases and 1,440 controls. It is estimated that each clinical center will enroll, interview, and examine 72 cases (age 21 years or older) with sarcoidosis and, enroll, interview and collect a blood specimen from 144 matched control subjects over a four year period. Clinical centers will 1) test specific hypotheses involving risk factors, familial aggregation, and genetics of the etiology of this disease and 2) describe the natural history of sarcoidosis. 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 patients and recruitment and interviewing of control subjects, and Phase III (12 Months): will involve data analysis.