CORE 1: The Clinical Data and Biospecimen Repository Core

核心 1：临床数据和生物样本存储库核心

• 批准号: 10625688
• 负责人: Maribeth Ruth Nicholson
• 金额: $ 24万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-03 至 2028-02-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10625688
• 关键词: Academic Medical Centers; Adult; Age; Aliquot; Antibodies; Antibody Response; Antigens; Basic Science; Biological; Biological Specimen Banks; Biological Specimen database; Blood; Child; Clinical; Clinical Data; Clinical Microbiology; Clinical Research; Clostridium difficile; Collaborations; Collection; Consent; Data; Data Element; Databases; Development; Elements; Enrollment; Ensure; Epidemiology; Evaluation; Feces; Future; Gastroenterology; Gender; Goals; Immune response; Immunity; Individual; Infection; Infection prevention; Institutional Review Boards; Laboratories; Link; Maintenance; Measures; Medical History; Medical center; Metadata; Microbiology; Morbidity - disease rate; Outcome; Outcome Measure; Participant; Patient Participation; Patient Recruitments; Patients; Peripheral Blood Mononuclear Cell; Pharmaceutical Preparations; Process; Protocols documentation; Records; Recurrent disease; Reproducibility; Research Personnel; Research Training; Residual state; Resources; Role; Saliva; Sampling; Secure; Serum; Source; Specimen; Standardization; System; Testing; Therapeutic; Time; Toxin; Toxoids; Translational Research; United States; Vaccines; Whole Blood; Work; administrative database; antibiotic-associated diarrhea; biobank; clinical data repository; clinical database; clinical outcome measures; cohort; data de-identification; demographics; high risk; member; mortality; participant enrollment; patient retention; primary care clinic; prospective; recruit; sample collection; stool sample; success; tertiary care; web platform

Project Summary- CORE 1 Clostridioides difficile infection (CDI) is the leading cause of antibiotic-associated diarrhea in the United States and associated with significant morbidity and mortality. Patients with CDI have high rates of recurrence of disease, with 20-30% of adults and children having additional infections. Evaluation of the immune response to CDI has focused primarily on the antibody response to CDI toxins. Unfortunately, CDI therapeutics and toxoid vaccines focused primarily on the immune response to toxins have produced disappointing results in CDI prevention to date. Additional evaluation of the host immune response to CDI is critical and best evaluated through basic and translational research as outlined in the Vanderbilt Antibody and Antigen Discovery for Clostridioides difficile Vaccines (VANDy-CdV) project. The Clinical Data and Biospecimen Repository Core (Core 1) will support the goals of the VANDy-CdV through a rich source of patient biospecimens and linked clinical data. Core 1 will be responsible for all elements of patient recruitment, enrollment, biospecimen collection, database integration, and patient retention. Trained research personnel will identify patients with CDI at a large tertiary care medical center through clinical microbiology laboratory records which process over 450 samples for C. difficile testing per month. After consent, residual stool samples will be obtained. At two weeks and two months after CDI, serum, whole blood, and saliva will be obtained. Clinical data and CDI-related outcomes will be measured at two weeks, two months, and six months after initial infection. Core 1 will enroll 40 CDI case patients identified through laboratory records and an additional 40 healthy controls recruited through primary care clinics. Core 1 will process, aliquot, and log all biospecimens for future use to support the aims of the VANDy-CdV team. Core 1 will also establish and maintain a repository of clinical data elements pre-determined to be essential to the aims of the VANDy-CdV project. De-identified data with linked biospecimens will be provided to VANDy-CdV members through a standardized and tracked approach. The end result of these efforts will be a carefully curated and maintained database of clinical data and biospecimens that will directly support the efforts of the VANDy-CdV team to investigate the critical role of host immunity in patients with CDI.

项目摘要 - 核心1 梭状芽胞杆菌艰难梭菌感染（CDI）是联合抗生素相关腹泻的主要原因 状态并与明显的发病率和死亡率相关。 CDI患者的复发率很高 疾病，有20-30％的成年人和儿童有其他感染。评估免疫反应 CDI主要集中于对CDI毒素的抗体反应。不幸的是，CDI疗法和 主要集中于对毒素免疫反应的毒素疫苗在 CDI预防迄今为止。 对宿主对CDI的免疫反应的其他评估至关重要，并且通过基本和 范德比尔特抗体和抗原发现中概述的翻译研究 疫苗（Vandy-CDV）项目。临床数据和生物测量存储库核心（核心1）将支持 Vandy-CDV的目标通过丰富的患者生物测量来源和连接的临床数据。核心1将是 负责患者招聘，入学，生物循环收集，数据库集成的所有要素， 和患者保留。训练有素的研究人员将在大型三级护理医疗中识别患有CDI的患者 通过临床微生物学实验室记录中心，该记录处理超过450个艰难梭菌测试的样品 每月。同意后，将获得残留的粪便样品。在CDI之后的两个星期零两个月， 将获得血清，全血和唾液。临床数据和与CDI相关的结果将在 初次感染后两个星期，两个月和六个月。 Core 1将招募40例CDI病例患者 通过实验室记录和通过初级保健诊所招募的另外40个健康对照。核心1 将处理，等分和记录所有生物测量，以供将来使用，以支持Vandy-CDV团队的目标。核 1还将建立并维护预先确定的临床数据要素的存储库，这对 Vandy-CDV项目的目的。将提供带有链接的生物测量的数据，将提供给Vandy-CDV 通过标准化和跟踪的方法成员。这些努力的最终结果将是一个谨慎的 策划和维护的临床数据和生物测量数据库，这些数据库将直接支持 Vandy-CDV团队研究宿主免疫在CDI患者中的关键作用。