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 艰难梭状芽胞杆菌感染(CDI)是美国抗生素相关性腹泻的主要原因 并与严重的发病率和死亡率有关。CDI患者复发率高 20%-30%的成人和儿童有额外的感染。免疫反应的评估 对CDI的研究主要集中在对CDI毒素的抗体反应。不幸的是，CDI疗法和 主要专注于对毒素的免疫反应的毒素疫苗在 到目前为止CDI预防。 对CDI的宿主免疫应答的额外评估是关键的，最好通过基本和 艰难梭状芽胞杆菌Vanderbilt抗体和抗原发现中的翻译研究 疫苗(Vandy-CDV)项目。临床数据和生物制品资料库核心(核心1)将支持 Vandy-CDV的目标是通过丰富的患者生物样本来源和相关的临床数据。核心1将是 负责患者招募、登记、生物样品收集、数据库整合、 和耐心保留。训练有素的研究人员将在大型三级医疗保健医院识别CDI患者 中心通过临床微生物学实验室记录处理了450多个艰难梭菌检测样本 每个月。同意后，将获得剩余的粪便样本。在CDI后两周和两个月， 将获得血清、全血和唾液。临床数据和CDI相关结果将在 初次感染后两周、两个月和六个月。CORE 1将招募40名确诊的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名健康对照。核心1 将对所有生物制剂进行处理、等量和记录，以供将来使用，以支持范迪-CDV团队的目标。堆芯 1还将建立和维护预先确定对以下各项至关重要的临床数据元素储存库 范迪-CDV项目的目标。将向Vandy-CDV提供与生物质谱学相关联的未识别数据 通过标准化和可跟踪的方法为会员服务。这些努力的最终结果将是一个谨慎的 管理和维护临床数据和生物检疫数据库，以直接支持 Vandy-CDV团队调查宿主免疫在CDI患者中的关键作用。