Project 1 - Beryllium Antigen: HLA Peptide, Metal Interactions

项目 1 - 铍抗原：HLA 肽，金属相互作用

• 批准号: 7714442
• 负责人: LEE S NEWMAN
• 金额: $ 31.28万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-11 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7714442
• 关键词: Adverse event; Appointments and Schedules; Beryllium; Biological; Biological Markers; Biometry; Blood; Blood Cells; Blood specimen; Bronchoalveolar Lavage; Cell Count; Cells; Clinical; Clinical Data; Clinical Research; Consent; Cost Savings; DNA; Data; Data Analyses; Data Base Management; Data Quality; Databases; Disease; Eligibility Determination; Enrollment; Ensure; Genetic; Grant; Health; Human; Immune; Individual; Industry; Informed Consent; Instruction; Irrigation; Laboratories; Laboratory Procedures; Letters; Maintenance; Measures; Notification; Principal Investigator; Procedures; Process; Public Health; Questionnaires; Reporting; Research Ethics Committees; Rights; Schedule; Serum; Services; Specimen; Specimen Handling; Standardization; Study Subject; Therapeutic; Time; Venipunctures; Visit; Work; cohort; follower of religion Jewish; human subject; human subject protection; laboratory facility; meetings; organizational structure; programs; prospective; reconstruction; research study; safety study

The Clinical Laboratory Core will be responsible for providing study recruitment, scheduling, enrollment and retention support, along with biological specimens to all of the projects. The Core will be responsible for maintaining the rights of human subjects and will process and provide the clinical biological specimens needed for the individual projects. By coordinating all clinical biological specimen processing activities in this Core, the Projects will realize a substantial cost savings. Importantly, by centralizing the specimen processing, it becomes possible to optimize the use of human specimens for as many experiments as possible and, [coordinate the sharing of specimens for simultaneous experiments conducted in Projects 1 and 3]. The Clinical Laboratory Core will provide the following five services: 1) study subject recruitment, scheduling, enrollment and retention support, including data entry of results obtained from these activities; 2) ensure protection of human subjects; 3) standardize specimen handling and distribution; 4) maximize utilization of biological specimens and ensure cost savings; and 5) provide standardized laboratory procedures for blood and bronchoalveolar lavage cells. Along with this, the Core will ensure that laboratory and clinical data generated through the Core are entered into the appropriate databases and are available to Project Leaders as needed. Interaction with Projects and Cores: The Clinical Laboratory Core will interact with the Administrative Core, as it provides the administrative and organizational structure to support this grant mechanism and the synergy between the Projects and Cores. This Core will report to the Administrative Core at monthly meetings of the Executive Committee and provide reports on its activities as needed otherwise. The Clinical Laboratory Core will work with the Biostatistics and Exposure Core which will set up and maintain databases, generate study identification numbers and perform routine data quality checks. The Clinical Laboratory Core will report to the Biostatistics and Exposure Core as to the subjects that are enrolled, so that they may obtain data from the clinical and demographic cohort databases as needed for data analysis for the individual Projects. This notification will trigger an exposure reconstruction to begin through the Biostatistics and Exposure Core staff, as appropriate for subjects enrolled in Projects 2 and 3. These measures will serve all Projects and result in considerable cost savings to the grant. RELEVANCE (See instructions): The reason some workers develop sensitization or disease when exposed to beryllium and others do not, is likely due to immune, genetic and exposure factors. The Clinical Laboratory Core will ensure the recruitment of subjects from a number of workforces, standardization of laboratory procedures and assurance of Human Subjects protection for all Projects in this POI. The Projects' results derived will have important public health implications regarding biomarkers, potential therapeutics and safe exposure limits applicable to industry.

临床实验室核心将负责提供研究招募、安排、注册和 保留支持以及所有项目的生物标本。核心将负责 维护人类受试者的权利并将处理和提供临床生物标本 各个项目所需的。通过协调本部门的所有临床生物样本处理活动 核心的是，这些项目将实现大幅成本节约。重要的是，通过集中样本 处理后，可以优化人体样本的使用，进行尽可能多的实验 可能，[协调项目 1 中同时进行的实验的样本共享 和3]。临床实验室核心将提供以下五项服务：1）研究受试者招募， 日程安排、注册和保留支持，包括从这些活动中获得的结果的数据输入； 2） 确保对人类受试者的保护； 3）规范标本处理和分发； 4）最大化 利用生物标本并确保节省成本； 5）提供标准化实验室 血液和支气管肺泡灌洗细胞的程序。除此之外，核心将确保实验室 通过核心生成的临床数据被输入适当的数据库并可供 根据需要担任项目负责人。与项目和核心的互动：临床实验室核心将互动 与行政核心，因为它提供了行政和组织结构来支持这一点 拨款机制以及项目和核心之间的协同作用。该核心将向 行政核心出席执行委员会的月度会议，并提供其活动报告 否则需要。临床实验室核心将与生物统计和暴露核心合作，后者将 设置和维护数据库，生成研究识别号并执行常规数据质量 检查。临床实验室核心将向生物统计和暴露核心报告受试者的情况 已登记，以便他们可以从临床和人口队列数据库中获取数据 各个项目的数据分析所需的。此通知将触发曝光重建 通过生物统计和暴露核心工作人员开始，视项目 2 中注册受试者的情况而定 3. 这些措施将为所有项目服务，并为赠款节省大量成本。 相关性（参见说明）： 一些工人在接触铍时会出现过敏或疾病，而其他工人则不会，原因是 可能是由于免疫、遗传和暴露因素造成的。临床实验室核心将确保招募 来自多个劳动力的受试者、实验室程序的标准化和人力保证 该 POI 中的所有项目均受保护。该项目的结果将对公众健康产生重要影响 关于适用于工业的生物标志物、潜在治疗方法和安全暴露限制的影响。