Continuation of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Data Coordinating Center

下尿路功能障碍症状延续研究网络 (LURN) 数据协调中心

基本信息

批准号：
10251160
负责人：
Robert M Merion
金额：
$ 102.01万
依托单位：
ARBOR RESEARCH COLLABORATIVE FOR HEALTH
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：
2013-07-25 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10251160
关键词：
Ancillary Study Bar Codes Biological Biological Assay Biological Markers Bladder Case Report Form Characteristics Charge Clinical Clinical Management Clinical Research Clinical Treatment Clinical Trials Collaborations Communication Communities Complex Consensus Data Data Analyses Data Collection Data Coordinating Center Development Diagnosis Diagnostic Disease Functional disorder Funding Future Goals Human Resources Infrastructure Institutional Review Boards Internist Knowledge Lead Leadership Logistics Lower urinary tract Manuscripts Measurement Measures Modeling Monitor Motor National Institute of Diabetes and Digestive and Kidney Diseases Organ Outcome Participant Patient Care Patient Monitoring Patient Self-Report Patient-Focused Outcomes Patients Performance Phase Phenotype Physiological Pilot Projects Plasma Policies Population Process Publications Reporting Research Research Design Research Personnel Sampling Scientist Secure Self Assessment Sensory Severities Site Subgroup Surveys Symptoms System Testing Time Treatment outcome Urethra Urinary Tract Finding Urinary tract Urodynamics Urologist Woman Work Writing base biomarker signature care outcomes clinical phenotype clinical research site cohort data management design expectation experience improved insight instrument lower urinary tract symptoms meetings men novel patient subsets protein biomarkers protocol development quality assurance recruit research study response symposium symptom treatment tertiary care tool treatment response treatment trial urinary web site

项目摘要

Project Summary In the Continuation of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN II), the investigators will advance the subtyping of study participants with Lower Urinary Tract Symptoms (LUTS) with the expectation that clinically useful patient subtypes will be identified. Research efforts will include continued analysis of data and biospecimens from LURN I and development of additional, new and novel collaborative studies to further improve our understanding of lower urinary tract dysfunction, both designed to generate findings that may inform future clinical studies (e.g., clinical treatment trials) and ultimately improve clinical management and patient outcomes. Studies will also refine and evaluate the longitudinal performance of clusters identified in LURN I for patient subtyping, including response to treatment. We will incorporate insights from the LURN I organ-based diagnostics pilot study and biomarker pilot studies. We will evaluate the LURN Comprehensive Assessment of Self-reported Urinary Symptoms (CASUS) instrument in populations with lesser severity of LUTS than seen in the tertiary care setting in LURN I. Consistent with the description in the RFA for this second funding cycle of LURN, the primary goal of this proposal is to better define clinical phenotypes of patients with LUTS, to better describe the impact and diversity of symptoms, and to develop new patient-centric tools for improved measurement of clinical symptoms, all with the goals of informing future clinical studies and improving patient care and outcomes. It is anticipated that the network will consist of up to six clinical sites and a single data coordinating center (DCC). The DCC for the LURN study is charged with providing coordination, communications and logistical support, clinical study design, centralized data management, biosample management, quality assurance, and analytical support to the research sites and the NIDDK Project Scientist for all LURN studies. The proposing team is submitting this response to RFA-DK-18-511 to continue as the DCC for the network.

项目概要在下尿路功能障碍症状研究网络 (LURN II) 的延续中，研究人员将推进对患有下尿路症状 (LUTS) 的研究参与者的亚型分类期望能够确定临床上有用的患者亚型。研究工作将包括继续分析来自 LURN I 的数据和生物样本并开发额外的、新的和新颖的协作研究进一步提高我们对下尿路功能障碍的理解，这两项研究都旨在产生可能为未来临床研究（例如临床治疗试验）提供信息并最终改善临床的发现管理和患者结果。研究还将完善和评估 LURN I 中为患者确定的簇的纵向性能亚型，包括对治疗的反应。我们将结合 LURN I 基于器官的见解诊断试点研究和生物标志物试点研究。我们将评估 LURN 综合评估自我报告泌尿系统症状 (CASUS) 工具适用于 LUTS 严重程度较轻的人群 LURN I 的三级护理环境。与 RFA 中对 LURN 第二个融资周期的描述一致，本次融资的主要目标该提案旨在更好地定义 LUTS 患者的临床表型，更好地描述其影响和症状的多样性，并开发新的以患者为中心的工具，以改进临床测量症状，所有这些都是为了为未来的临床研究提供信息并改善患者护理和结果。这是预计该网络将由多达六个临床站点和一个数据协调中心（DCC）组成。 LURN 研究的 DCC 负责提供协调、沟通和后勤支持，临床研究设计、集中数据管理、生物样本管理、质量保证和分析为所有 LURN 研究的研究中心和 NIDDK 项目科学家提供支持。提案团队是将此回复提交给 RFA-DK-18-511 以继续担任网络的 DCC。