ETIOLOGY OF SARCOIDOSIS A CASE CONTROL STUDY

结节病的病因学病例对照研究

• 批准号: 6315937
• 负责人: Henry Yeager
• 金额: --
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-07-17 至 2000-07-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6315937
• 关键词: biomarker; case history; clinical trials; data collection; disease /disorder proneness /risk; family genetics; handbook; human subject; immunity; information systems; longitudinal human study; pathologic process; patient care management; sarcoidosis; tissue resource /registry

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.

该计划的总体目的是支持多中心案例 - 对照研究的结节病潜在病因因素。 案例 还将遵循以获取有关自然历史的信息 疾病，包括疾病进展的危险因素。 转向 委员会将制定一项协议和手册，将 解决最有前途的假设，以确定 结节病的原因。 该协议将包括一个综合 每个参与者的临床表征和标记的确定 免疫反应能力。 承包商将参加 银行生物标本。 将建立一个临床协调中心，以收集，管理和 分析来自临床中心的数据。 据估计 总研究人群将由720例和1,440例对照组成。 它 据估计，每个临床中心将注册，面试和检查 72例（21岁或以上）患有结节病，注册，面试 并从四个匹配的对照对象中收集一个血液标本 年期。 临床中心将1）检验涉及的特定假设 这种病因的危险因素，家族聚集和遗传学 疾病和2）描述结节病的自然史。 六年 时间表的设想如下：第一阶段（12个月）：协作 将制定协议和手册；第二阶段（48个月）： 将涉及患者和招聘的招聘和随访以及 对照对象的访谈和第三阶段（12个月）：将涉及 数据分析。