Minnesota Precision Medicine CKD & Resilient Diabetes Recruiting Site: Engagement, Enrollment & Ethics

项目总结 慢性肾脏疾病(CKD)是与高发病率和高死亡率相关的重要健康问题。 解开与慢性肾脏病风险或保护相关的机制将显著提高精确度- CKD的预防、诊断和治疗的医学方法。 明尼苏达州-KPMP(明尼苏达州-KPMP)将道德和安全地获得研究肾脏活检，生物样本，和 来自表型良好的糖尿病或高血压CKD患者和无糖尿病或高血压患者的数据 CKD的临床表现，尽管有数十年的1型糖尿病(T1D)。在一个高度多样化的大都市地区 积极面对种族主义和不平等，明尼苏达州-KPMP将吸引不同的患者群体来评估和 解决参加KPMP的障碍，并征求我们当地参与者对道德问题的看法 由KPMP提出的问题，如返回结果和生物库治理。这将显著增加KPMP 社区参与和道德规范。 利用明尼苏达临床大学的生物医学信息学和数据访问服务 翻译科学研究所(CTSI)最佳实践集成信息学核心(BPIC)，我们将询问 大型mHealth Fairview(MHealth)数据库，用于识别、招募、登记和获取临床数据、生物样本和 CKD-糖尿病、CKD-高血压和弹性-T1D患者的肾活检。我们将密切合作 使用KPMP，并帮助完善和遵循常见的研究方案，同时遵循最大限度的安全预防措施。 我们团队在招募患者参加CKD临床试验方面的长期成功记录，以及我们的 同意肾活检的伦理严格方法和严格遵守KPMP安全措施将 确保我们对KPMP的使命和目标做出有意义的贡献。 Minn-KPMP组建了一支由调查人员和顾问组成的优秀团队来招募和跟踪 患有慢性肾脏病和弹性T1D(RES-T1D)的参与者。与这一应用程序直接相关的Minn-KPMP 学习团队在成功招募、跟踪、安全和合乎道德的情况下有着长期的记录 在广泛的参与者中进行研究性肾脏活检，包括顺序肾脏活检， 包括患有糖尿病且无CKD临床表现的参与者、患有糖尿病的兄弟姐妹、肾脏 捐赠者、肾移植接受者和胰腺移植接受者。获得高质量的生物样本， 包括来自表型良好的研究参与者的肾活检样本是KPMP成功的关键，因此这些 组织可用于转录组、蛋白质组和代谢组学分析。Minn-KPMP渴望和 做好充分准备，与其他KPMP招募站点、组织审问站点、中央中心、指导站点协作 委员会、密歇根州立大学、外部专家小组和金伯利进程管理计划的近300名成员。

PROJECT SUMMARY Chronic kidney disease (CKD) is an important health problem associated with high morbidity and mortality. Unraveling the mechanisms associated with risk of or protection from CKD will significantly advance a precision- medicine approach to CKD prevention, diagnosis, and treatment. The Minnesota-KPMP (Minn-KPMP) will ethically and safely obtain research kidney biopsies, biosamples, and data from well phenotyped participants with CKD due to diabetes or hypertension and from patients with no clinical manifestations of CKD despite decades of type 1 diabetes (T1D). In a highly diverse metropolitan area actively confronting racism and disparities, Minn-KPMP will engage a diverse patient population to evaluate and address barriers to enrollment in KPMP and to elicit the perspectives of our local participants on ethical issues posed by the KPMP, such as return of results and biobank governance. This will add significantly to KPMP community engagement and ethics. Leveraging the Biomedical Informatics and Data Access service of the University of Minnesota Clinical and Translational Science Institute (CTSI) Best Practices Integrated Informatics Core (BPIC), we will interrogate the large MHealth Fairview (MHealth) database to identify, recruit, enroll, and obtain clinical data, biosamples, and kidney biopsies from patients with CKD-Diabetes and CKD-Hypertension and resilient-T1D. We will work closely with KPMP and help to refine and follow common study protocols while following maximum safety precautions. The long-standing successful track record of our group in recruiting patients into clinical trials of CKD, and our ethically rigorous approach to consenting for kidney biopsy and strict adherence to KPMP safety measures will ensure our meaningful contribution to the KPMP mission and goals. Minn-KPMP has assembled an outstanding team of investigators and consultants to recruit and follow participants with CKD and with resilient T1D (Res-T1D). Directly relevant to this application, the Minn-KPMP study team has a long-standing track record of successfully recruiting, following-up, and safely and ethically performing research kidney biopsies, including sequential kidney biopsies, in a wide range of participants, including participants with diabetes and with no clinical manifestations of CKD, siblings with diabetes, kidney donors, kidney transplant recipients, and pancreas transplant recipients. Obtaining high quality biosamples, including kidney biopsy samples, from well phenotyped study participants is key to KPMP success, so that these tissues can be used for transcriptomic, proteomic, and metabolomic analyses. The Minn-KPMP is eager and fully prepared to collaborate with the other KPMP recruiting sites, tissue interrogation sites, central hub, steering committee, DSMB, external expert panel, and the almost 300 members of the KPMP.