Clinical Samples Core

临床样本核心

• 批准号: 10356727
• 负责人: Royce H Johnson
• 金额: $ 8.1万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-24 至 2026-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10356727
• 关键词: Age; Blood; Bronchoalveolar Lavage; California; Case Report Form; Clinical; Clinical Data; Clinical Investigator; Coccidioidomycosis; Code; County; Data; Diagnostic; Ensure; Ethics; Genetic; Genomics; Goals; Human; Immunogenetics; Immunologics; Infection; Infrastructure; Institutes; Institution; Institutional Review Boards; Medical; Patients; Phenotype; Protocols documentation; Research; Research Design; Research Personnel; Running; Sampling; Services; Shipping; Site; Specimen; Statistical Data Interpretation; System; Universities; Virulence; Work; base; clinical phenotype; clinical research site; cohort; desert fever; electronic consent; human subject; phenotypic data; programs; synergism

Abstract The Clinical Core is integral to our CCRC’s activities coordinating and overseeing the access and distribution of biospecimens obtained from well characterized coccidioidomycosis patients to all investigators. This core will also provide regulatory support and, when necessary, assistance with study design and statistical analysis. This Core strengthens the coalition of expert clinical investigators with the fundamental aim of obtaining biospecimens and comprehensive clinical data from subjects with coccidioidomycosis. Our program has partnered with the two largest coccidioidomycosis clinical facilities in California: the Valley Fever Institute (VFI) affiliated with the Kern County Medical System and located in Bakersfield, the epicenter of coccidioidomycosis at the southern end of the California Central Valley; and the University of California Davis (UCD) Center of Excellence in Valley Fever, located at the northern end of the Central Valley. These two centers, and the skilled clinicians who run them, offer our program premier access to the key specimens and data needed to identify the genetic and immunological causes of disseminated coccidioidomycosis (DCM). Coordinating patient samples from two foremost institutions ensures a broadest variety of clinical phenotypes and diverse genomic ancestries of the patients drawn from across the Central Valley of the state of California, and a major strength of this Core is that the patient base we sample from will be among the largest and most diverse ever collected for coccidioidomycosis. We propose two straightforward aims in this core. First, in Aim 1, we will provide clinical samples and data. Biospecimens include blood and bronchoalveolar lavage specimens. Samples will be coded to de-identify. Phenotype information will be captured in an electronic clinical Case Report Form and stored in REDCap. This Core will work with the Administrative core to ensure oversight over samples. In Aim 2, the Clinical Core will ensure ethical approvals and human subjects approvals are all in place. Biosafety protocols for shipping and handling diagnostic specimens from patients will be developed and followed. The Clinical Core thus provides critical infrastructure and services for our research program to meet its goals for all Projects requiring human specimens.

抽象的 临床核心是我们CCRC的活动协调和监督访问和分配不可或缺的一部分 从表征良好的球菌病患者获得的生物菌群给所有研究者。这个核心将 还提供监管支持，并在必要时提供研究设计和统计分析的帮助。 该核心强调了专家临床研究人员的联盟，其基本目的是 来自coccidioysomycisois的受试者的生物测量和综合临床数据。我们的计划有 与加利福尼亚州的两个最大的球虫菌病临床设施合作：山谷发烧研究所（VFI） 隶属于克恩县的医疗系统，位于贝克斯菲尔德，是球菌病的中心 在加利福尼亚中央山谷的南端；加州大学戴维斯分校（UCD）中心 山谷热的卓越，位于中央山谷的北端。这两个中心和熟练的 运行它们的临床医生，提供我们计划的总理访问权限的主要标本和数据，以识别 传播球菌病（DCM）的遗传和免疫学原因。协调患者样品 来自两个最重要的机构可确保最广泛的临床表型和潜水员的基因组祖先 从加利福尼亚州的中央山谷中汲取的患者中，该核心的主要优势 是我们采样的患者基础将是有史以来收集的最大，最多样化的之一 球菌病。 我们在此核心中提出了两个直接的目标。首先，在AIM 1中，我们将提供临床样本和数据。 生物测量包括血液和支气管肺泡灌洗标本。样品将被编码以取消识别。 表型信息将以电子临床病例报告形式捕获，并存储在REDCAP中。这 核心将与行政核心合作，以确保对样本进行监督。在AIM 2中，临床核心将 确保符合道德的批准和人类受试者的批准。运输的生物安全协议 将开发并遵循患者的诊断标本。 因此，临床核心为我们的研究计划提供了关键的基础架构和服务，以实现其目标 对于所有需要人类标本的项目。