Kidney Precision Medicine Program (KPMP): Columbia AKI Recruitment Site

肾脏精准医学计划 (KPMP)：哥伦比亚 AKI 招聘网站

• 批准号: 9911000
• 负责人: JONATHAN M. BARASCH
• 金额: $ 30万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9911000
• 关键词: Academic Medical Centers; Acute Renal Failure with Renal Papillary Necrosis; Address; Adult; Affect; African American; Area; Basic Science; Biological Markers; Biopsy; Biopsy Specimen; Blood; Blood Cells; Cardiovascular system; Cells; Chronic Kidney Failure; Clinical; Clinical Data; Clinical Sciences; Collaborations; Collection; Communities; Complement; Computerized Medical Record; Consensus; Consult; Core Biopsy; Coupled; Couples; Critical Pathways; Data; Data Collection; Diagnosis; Diagnostic; Electronic Health Record; Enrollment; Ensure; Epidemiology; Etiology; Event; Feces; Foundations; Functional disorder; Genetic; Genetic Markers; Genetic Processes; Goals; Gold; Histopathology; Hypertension; Injury; Injury to Kidney; Inpatients; Kidney; Kidney Diseases; LCN2 gene; Latino; Life; Longitudinal Studies; Longitudinal cohort; Measurement; Measures; Medical; Medical Genetics; Methods; Molecular; Morbidity - disease rate; Nephrology; Nephrons; New York; Outcome; Participant; Patients; Persons; Phase; Plasma; Protocols documentation; Renal Mass; Renal function; Research; Research Personnel; Resources; Response to stimulus physiology; Risk; Risk Factors; Role; Route; Saliva; Scientist; Sepsis; Serum; Services; Site; Solid; Standardization; Stimulus; Surveys; Techniques; Technology; Testing; Therapeutic; Time; Time trend; Tissues; To specify; Uncertainty; Universities; Urine; Visit; Work; base; cohort; diagnosis standard; effective therapy; expectation; experience; follow-up; genomic biomarker; genomic data; global health; interest; kidney biopsy; metropolitan; microbiome research; mortality; multidisciplinary; nephrotoxicity; novel; patient engagement; precision medicine; programs; prospective; recruit; renal damage; response; response to injury; targeted treatment

Project Summary (Abstract) Our project brings together an experienced multidisciplinary team of clinical and basic scientist investigators at Columbia University Medical Center with expertise in the fields of genetics, biomarkers, pathophysiology, histopathology, renal biopsies, and therapy for kidney diseases to meet the aims of the Kidney Precision Medicine Project (KPMP) Recruitment Site for acute kidney injury (AKI). Our primary objective in establishing this site is to apply precision medicine techniques to patient biospecimens, including renal biopsies, and longitudinal clinical data to understand the etiology of kidney damage and determine critical pathways that can be targeted for therapy. The KPMP will occur in two phases: the UG3 exploratory phase and the UH3 expansion phase. Leveraging our existing inpatient nephrology consult services, we will create a multiethnic cohort (including >50% enrollment of Latino and/or African-American subjects) of at least 200 patients with AKI over five years. In the exploratory phase of the project, we will enroll at least 50 subjects over two years and will standardize the collection of biospecimens from all study participants including blood, saliva, urine, stool, and renal biopsy samples collected specifically for research purposes. The biospecimens will be pre-processed for genetic, genomic, biomarker, and microbiome studies before the material is transferred to the KPMP Central Hub. To track patient progress and outcomes, a longitudinal study protocol will be used consisting of “dynamic” follow-up visits through electronic health records and yearly in-person visits. In addition, we will share all extracted electronic health record data, survey data, and longitudinal clinical data from follow-up visits from our participants with the larger KPMP initiative for collaborative purposes. In the expansion phase, we will increase the cohort size by enrolling an additional 150 patients over three years and use KPMP consortium- wide established protocols from the exploratory phase for biospecimen collection and longitudinal clinical data collection. We will perform proof-of-concept studies with the longitudinal cohort of 200 Columbia patients with AKI to determine a standard set of outcomes based on risk factors, known serum biomarkers, and genomic data. Lastly, we will work with local kidney foundation chapters and community engagement experts to ensure that the aims of the national KPMP are shared with the larger community so that participants understand the importance of this initiative and the long-term benefits of continued study involvement. We expect that this novel, tissue-based, mechanism-centered approach will challenge the traditional methods for diagnosing and treating AKI and will contribute to the overall goals of the national KPMP.

项目摘要(摘要) 我们的项目汇集了一支经验丰富的多学科临床和基础科学家研究团队，位于 哥伦比亚大学医学中心，在遗传学、生物标记物、病理生理学、 肾组织病理学、肾活检和肾脏疾病的治疗以达到肾脏精确术的目标 医学计划(KPMP)急性肾损伤(AKI)招募网站。我们的主要目标是建立 该网站旨在将精确医学技术应用于患者的生物标本，包括肾脏活检，以及 纵向临床数据，以了解肾脏损害的病因并确定关键途径 成为治疗的目标。KPMP将分两个阶段进行：UG3探索阶段和UH3 扩展阶段。利用我们现有的住院肾病会诊服务，我们将创造一个多元化的 至少200名AKI患者的队列(包括50%的拉丁裔和/或非裔美国人受试者) 五年多了。在项目的探索阶段，我们将在两年内招收至少50个科目，并 将标准化收集所有研究参与者的生物样本，包括血液、唾液、尿液、粪便、 和专门为研究目的收集的肾活检样本。这些生物检疫剂将经过前处理 在材料被转移到KPMP之前，用于遗传、基因组、生物标记和微生物组研究 中央枢纽。为了跟踪患者的进展和结果，将使用包括以下内容的纵向研究方案 通过电子健康记录和每年面对面的探视进行“动态”跟踪探视。此外，我们还将 共享所有提取的电子健康记录数据、调查数据和后续访问的纵向临床数据 从我们的参与者那里获得更大的KPMP倡议，以实现合作目的。在扩展阶段，我们将 扩大队列规模，在三年内再招募150名患者，并使用KPMP联盟- 从探索阶段开始广泛建立的生物样品采集和纵向临床数据方案 收集。我们将对200名哥伦比亚患者进行概念验证研究 AKI根据危险因素、已知的血清生物标志物和基因组确定一组标准的结果 数据。最后，我们将与当地肾脏基金会分会和社区参与专家合作，以确保 国家淘汰管理计划的目标与更大的社区共享，以便参与者了解 这一倡议的重要性以及继续参与研究的长期好处。我们预计这一次 新的、基于组织的、以机制为中心的方法将挑战传统的诊断和治疗方法 治疗急性KI，并将有助于实现国家KPMP的总体目标。