CLINICAL CENTER FOR ETIOLOGY OF SARCOIDOSIS

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 例 也将被跟踪，以获得有关这一自然历史的信息。 疾病，包括疾病进展的风险因素。 转向 委员会将制定一项议定书和业务手册， 解决最有希望的假设，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。 承包商将参加一个系统， 生物标本库 将建立一个临床协调中心，收集、管理和 分析来自临床中心的数据。 预计全年 总研究人群将包括720例病例和1，440例对照。 它 估计每个临床中心都将招募、面试和检查 72例结节病病例（年龄≥ 21岁），入组，访谈 并从144名匹配的对照受试者中收集血液样本， 年期间。 临床中心将1）检验特定假设， 危险因素，家族聚集性，和遗传学的病因， 疾病和2）描述结节病的自然史。 六年 第一阶段（12个月）：合作 将制定方案和操作手册;第二阶段（48个月）： 将涉及患者的招募和随访以及招募和 对照组受试者访谈和第III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. 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.