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 艰难梭菌感染 (CDI) 是美国抗生素相关性腹泻的主要原因 状态并与显着的发病率和死亡率相关。 CDI患者复发率高 20-30% 的成人和儿童患有其他感染。免疫反应评估 to CDI 主要关注针对 CDI 毒素的抗体反应。不幸的是，CDI 疗法和 主要针对毒素免疫反应的类毒素疫苗在以下方面产生了令人失望的结果： 迄今为止的 CDI 预防。 对 CDI 宿主免疫反应的额外评估至关重要，最好通过基本和 范德比尔特艰难梭菌抗体和抗原发现中概述的转化研究 疫苗（VANDy-CdV）项目。临床数据和生物样本存储库核心（核心 1）将支持 通过丰富的患者生物样本来源和关联的临床数据来实现 VANDy-CdV 的目标。核心 1 将是 负责患者招募、登记、生物样本收集、数据库集成的所有要素， 和患者保留率。训练有素的研究人员将在大型三级医疗机构中识别 CDI 患者 中心通过临床微生物学实验室记录处理超过 450 个样本进行艰难梭菌检测 每月。征得同意后，将获取残留粪便样本。 CDI 后两周零两个月时， 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。核心 1 将招募 40 名已确诊的 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 名健康对照者进行研究。核心1 将处理、等分并记录所有生物样本以供将来使用，以支持 VANDy-CdV 团队的目标。核 1 还将建立并维护一个预先确定的临床数据元素存储库，这些元素对 VANDy-CdV 项目的目标。带有链接生物样本的去识别化数据将提供给 VANDy-CdV 成员通过标准化和跟踪的方法。这些努力的最终结果将是一个仔细的 策划和维护临床数据和生物样本数据库，这将直接支持 VANDy-CdV 团队研究宿主免疫在 CDI 患者中的关键作用。