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

项目概要 慢性肾脏病（CKD）是一个与高发病率和死亡率相关的重要健康问题。 阐明与 CKD 风险或保护相关的机制将显着提高精确度 CKD 预防、诊断和治疗的医学方法。 明尼苏达州 KPMP (Minn-KPMP) 将合乎道德且安全地获取研究性肾活检、生物样本和 来自因糖尿病或高血压而患有 CKD 的表型良好的参与者以及没有患有 CKD 的患者的数据 尽管患有 1 型糖尿病 (T1D) 数十年，但仍出现 CKD 的临床表现。在高度多元化的大都市区 为了积极应对种族主义和差异，Minn-KPMP 将让不同的患者群体参与评估和 解决加入 KPMP 的障碍，并征求当地参与者对道德问题的看法 由 KPMP 提出，例如结果返回和生物样本库治理。这将显着增加 KPMP 社区参与和道德。 利用明尼苏达大学临床和实验室的生物医学信息学和数据访问服务 转化科学研究所 (CTSI) 最佳实践综合信息学核心 (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 患有 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 与 KPMP 合作，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。 我们小组在招募患者参加 CKD 临床试验方面长期以来的成功记录，以及我们的 以道德严格的方式同意肾活检并严格遵守 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 组建了一支优秀的调查员和顾问团队来招募和跟踪 患有 CKD 和弹性 T1D (Res-T1D) 的参与者。与此应用直接相关的是 Minn-KPMP 研究团队在成功招募、随访以及安全和道德方面拥有长期的记录 对广泛的参与者进行研究性肾活检，包括连续肾活检， 包括患有糖尿病且无 CKD 临床表现的参与者、患有糖尿病、肾病的兄弟姐妹 捐赠者、肾移植受者和胰腺移植受者。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 组织可用于转录组学、蛋白质组学和代谢组学分析。明尼苏达州毕马威会计师事务所 (Minn-KPMP) 热心并 充分准备好与其他 KPMP 招募地点、组织审讯地点、中心枢纽、指导机构合作 委员会、DSMB、外部专家小组以及 KPMP 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.