GDPrime

GDP时代

基本信息

批准号：
9115573
负责人：
DEBBIE S GIPSON
金额：
$ 90.71万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-16 至 2018-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9115573
关键词：
Address Adult Advocate Ancillary Study Area Biology Biopsy Cessation of life Characteristics Child Childhood Chronic Clinical Clinical Trials Cohort Studies Collaborations Communities Creatinine Data Data Analyses Data Coordinating Center Data Reporting Data Set Development Diagnosis Discipline Disease Disease Progression End stage renal failure Ensure Epidemiology Evaluation Event Extramural Activities Focal Segmental Glomerulosclerosis Functional disorder Genetic Polymorphism Goals Health Idiopathic Membranous Nephropathy Immunoglobulin A Individual Kidney Kidney Diseases Knowledge Extraction Lead Measures Medical Genetics Medicine Membranous Glomerulonephritis Molecular Molecular Genetics Monitor Outcome Outcome Measure Pathway interactions Patients Phase Physical Function Population Private Sector Process Prognostic Marker Proteinuria Public Sector Quality of life Recruitment Activity Renal function Renal glomerular disease Research Research Design Research Infrastructure Research Personnel Research Support Resources Sampling Science Scientist Specific qualifier value Specimen Symptoms System Systems Biology Testing Text Therapeutic Training United States Validation Work base biobank case control cohort data integration data integrity data management demographics diagnostic biomarker dissemination research effective therapy empowered genome-wide human subject protection improved new therapeutic target novel novel marker novel therapeutics outcome forecast outcome prediction predict clinical outcome predictive marker prevent programs prospective protocol development response success targeted treatment therapeutic target

项目摘要

DESCRIPTION (provided by applicant): This Data Coordinating Center (DCC) application is submitted in response to RFA-DK-12-014 to establish a primary glomerular disease (GDPrime) consortium with a focus on minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), immunoglobulin A nephropathy (IGAN), and idiopathic membranous nephropathy (IMN). Taken together these diseases are responsible for significant symptom burden, chronic health challenges, and progressive loss of kidney function over 1 to 20 years contributing to 10% of incident end stage kidney disease (ESRD) patients per year in the USA. Despite the health burden imposed by primary glomerular disease, significant gaps in understanding disease pathophysiology, diagnosis, monitoring, prognosis and clinical trials exists and have prevented the implementation of effective therapy for these conditions. The GDPrime consortium will establish a comprehensive research platform centered around a prospective, observational cohort study of 2400 cases and 2400 controls. The overarching goal of the DCC application is to establish the data coordinating center to provide the study design, data management and analysis expertise for the consortium and associated ancillary studies. The GDPrime DCC will establish the infrastructure for conduct of the GDPrime study; coordinate the prospective longitudinal cohort study of children and adults with primary glomerular disease and healthy controls; define disease course and investigate predictors of outcomes in patients compared with non-disease controls and their associations with disease progression. The GDPrime DCC and overall consortium will establish a comprehensive ancillary study program for extramural collaboration and partnership to advance the identification and evaluation of novel biomarkers, therapeutic targets, outcome measures and as yet undefined research proposed by the scientific community at large.

描述（由申请人提供）：本数据协调中心 (DCC) 申请是根据 RFA-DK-12-014 提交的，旨在建立原发性肾小球疾病 (GDPrime) 联盟，重点关注微小病变疾病 (MCD)、局灶性节段性肾小球疾病 (GDPrime)肾小球硬化症 (FSGS)、免疫球蛋白 A 肾病 (IGAN) 和特发性膜性肾病 (IMN)。总的来说，这些疾病会导致严重的症状负担、慢性健康挑战以及 1 至 20 年内肾功能的逐渐丧失，导致美国每年 10% 的终末期肾病 (ESRD) 患者发生这种情况。尽管原发性肾小球疾病造成了健康负担，但在了解疾病病理生理学、诊断、监测、预后和临床试验方面仍存在显着差距，并阻碍了对这些疾病的有效治疗。 GDPrime 联盟将建立一个综合研究平台，以对 2400 例病例和 2400 例对照进行前瞻性观察队列研究为中心。 DCC 应用程序的总体目标是建立数据协调中心，为联盟和相关辅助研究提供研究设计、数据管理和分析专业知识。 GDPrime DCC 将建立进行 GDPrime 研究的基础设施；协调患有原发性肾小球疾病的儿童和成人以及健康对照者的前瞻性纵向队列研究；定义疾病进程并研究与非疾病对照相比患者结果的预测因素及其与疾病进展的关联。 GDPrime DCC 和整个联盟将建立一个全面的辅助研究计划，用于校外合作和伙伴关系，以推进对新型生物标志物、治疗目标、结果测量以及整个科学界提出的尚未定义的研究的识别和评估。