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: 9394618
• 负责人: JONATHAN M. BARASCH
• 金额: $ 41.38万
• 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 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9394618
• 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; Generic Drugs; 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; Recruitment Activity; 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; metropolitan; microbiome; mortality; multidisciplinary; nephrotoxicity; novel; precision medicine; programs; prospective; 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） 我们的项目汇集了经验丰富的临床和基础科学家研究人员的多学科团队， 哥伦比亚大学医学中心在遗传学、生物标志物、病理生理学、 组织病理学，肾活检和肾脏疾病的治疗，以满足肾脏精确的目标 急性肾损伤（阿基）医学项目（KPMP）招募网站。我们的首要目标是建立 该网站将精确医学技术应用于患者生物标本，包括肾活检， 纵向临床数据，以了解肾损伤的病因，并确定关键途径， 成为治疗的目标KPMP将分两个阶段进行：UG 3勘探阶段和UH 3 扩张阶段。利用我们现有的住院肾病咨询服务，我们将创建一个多民族的 至少200例阿基患者的队列（包括>50%的拉丁裔和/或非洲裔美国受试者入组） 超过五年。在该项目的探索阶段，我们将在两年内招募至少50名受试者， 将标准化所有研究参与者的生物标本采集，包括血液、唾液、尿液、粪便， 以及专门为研究目的收集的肾活检样本。生物样本将进行预处理 在材料转移到KPMP之前进行遗传、基因组、生物标志物和微生物组研究 中央枢纽。为了跟踪患者进展和结局，将使用纵向研究方案，包括 通过电子健康记录和每年亲自访问进行“动态”随访。此外，我们将 共享所有提取的电子健康记录数据、调查数据和随访的纵向临床数据 从我们的参与者与更大的KPMP倡议合作的目的。在扩展阶段，我们将 通过在3年内额外招募150例患者来增加队列规模，并使用KPMP联盟- 从探索阶段开始，生物标本采集和纵向临床数据的广泛确立方案 收藏.我们将对200名哥伦比亚患者的纵向队列进行概念验证研究， 基于风险因素、已知的血清生物标志物和基因组标记物， 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， 国家KPMP的目标与更大的社区共享，以便参与者了解 这一举措的重要性和继续参与研究的长期益处。我们期望这 一种新的、基于组织的、以机制为中心的方法将挑战传统的诊断和 治疗阿基，并将有助于实现国家KPMP的总体目标。