Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.

通过在印第安纳州不同且服务不足的人群中进行实用试验来实施基因组医学。

• 批准号: 10820224
• 负责人: Paul Dexter
• 金额: $ 57.79万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-19 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10820224
• 关键词: APOL1 gene; Acute; Address; Administrative Supplement; Adult; Affect; African American population; African ancestry; Antidepressive Agents; Behavior; Blood Pressure; Chronic Kidney Failure; Clinical; Clinical Trials; Diagnosis; Diffusion; Foundations; Funding; Genetic Risk; Genomic medicine; Genomics; Genotype; Grant; Hypertension; Indiana; Individual; Kidney; Kidney Diseases; Kidney Failure; Knowledge; Mental Depression; Methods; Opioid; Outcome; Pain; Participant; Patient Outcomes Assessments; Patient Recruitments; Patient-Focused Outcomes; Patients; Personal Satisfaction; Persons; Pharmaceutical Preparations; Pharmacogenetics; Pharmacotherapy; Pilot Projects; Population; Population Heterogeneity; Postoperative Pain; Pragmatic clinical trial; Provider; Randomized; Safety; Selection for Treatments; Test Result; Testing; Underserved Population; United States; Universities; chronic pain; clinical care; cost effective; cost effectiveness; design; disease disparity; economic impact; genetic information; genetic testing; genetic variant; health care service utilization; health difference; hypertension control; improved; method development; pharmacogenetic testing; pragmatic trial; primary endpoint; recruit; secondary analysis; secondary outcome

The IGNITE (Implementing Genomics in Practice) Consortium was created to enhance the use of genomic medicine by supporting the development of methods for incorporating genomic information into clinical care and exploration of the methods for effective implementation, diffusion and sustainability in diverse clinical settings. The IGNITE II grant was designed to establish the foundation for selected pragmatic clinical trials. As part of the network funding, the Indiana University Clinical Group is recruiting participants into both the ADOPT-PGx (A Depression and Opioid Pragmatic Trial in Pharmacogenetics) and GUARDD-US (Genetic Testing to Understand and Address Renal Disease Disparities across the United States) clinical trials. GUARDD-US: This trial aims to recruit African Americans with hypertension, with or without chronic kidney disease, randomized to immediate versus delayed return of APOL1 genetic testing results. In those who are APOL1 negative, we will also conduct a pilot study to test the impact of pharmacogenetic testing on systolic blood pressure. Secondary outcomes include 6-month systolic blood pressure in chronic kidney disease patients, medications ordered, renal diagnosis and testing, patient psycho-behavioral outcomes, cost effectiveness, and the effect of pharmacogenetic-guided hypertension management on systolic blood pressure. ADOPT-PGx: This randomized pragmatic genotype-guided clinical trial tests the effect of genotype-guided therapy in three scenarios of patients: acute post-surgical pain, chronic pain, and depression. For each scenario, participants are randomized to genotype-guided drug therapy versus usual approaches to drug therapy selection. Changes in patient reported outcomes representing pain and depression control using standard PROMIS scales define the primary endpoints. Secondary analyses include safety endpoints, changes in overall well-being, and economic impact represented by differences in healthcare utilization. The Administrative Supplement supports the continuation and conclusion of GUARDD-US and ADOPT-PGx.

IGNITE(在实践中实施基因组学)联盟是为了加强基因组学的使用而创建的 通过支持将基因组信息结合到临床护理中的方法的开发来提供医学 并探索在不同临床环境下有效实施、推广和持续的方法 设置。IGNITE II拨款旨在为选定的实用临床试验奠定基础。AS 作为网络资金的一部分，印第安纳大学临床小组正在招募参与者参加这两个 采用-PGx(药物遗传学中的抑郁症和阿片类药物实用试验)和GUARDD-US(遗传学 了解和解决美国各地肾脏疾病差异的测试)临床试验。 GUARDD-US：这项试验旨在招募患有高血压、有或没有慢性肾脏的非裔美国人 疾病，随机将APOL1基因检测结果立即返回与延迟返回。在那些 APOL1为阴性，我们还将进行一项初步研究，以测试药物遗传学测试对收缩压的影响 血压。次要结果包括慢性肾脏疾病患者6个月的收缩压 患者、订购的药物、肾脏诊断和检测、患者的心理行为结果、费用 药物遗传学指导下的高血压治疗对收缩压的影响。 采用-PGx：这项随机、实用、基因引导的临床试验测试了基因引导的效果 针对三种情况的患者进行治疗：急性术后疼痛、慢性疼痛和抑郁。对于每个 情景中，参与者被随机分为两组，分别接受基因引导的药物治疗和通常的药物治疗 治疗选择。患者报告的表现为疼痛和抑郁控制的结果的变化 标准Promis比例尺定义了主端点。二次分析包括安全端点、变化 在总体幸福感方面，以及医疗保健利用方面的差异所代表的经济影响。 《行政补编》支持《GUARDD-US》和《采用-PGx》的继续和结束。

项目成果

Transforming primary medical research knowledge into clinical decision.

将初级医学研究知识转化为临床决策。

• 发表时间: 2020
• 期刊: AMIA ... Annual Symposium proceedings. AMIA Symposium
• 作者: Dexter,PaulR;Grout,RandallW;Embi,PeterJ
• 通讯作者: Embi,PeterJ

CYP2C8, CYP2C9, and CYP2C19 Characterization Using Next-Generation Sequencing and Haplotype Analysis: A GeT-RM Collaborative Project.

• DOI: 10.1016/j.jmoldx.2021.12.011
• 发表时间: 2022-04
• 期刊: JOURNAL OF MOLECULAR DIAGNOSTICS
• 影响因子: 4.1
• 作者: Gaedigk, Andrea;Boone, Erin C.;Scherer, Steven E.;Lee, Seung-been;Numanagic, Ibrahim;Sahinalp, Cenk;Smith, Joshua D.;McGee, Sean;Radhakrishnan, Aparna;Qin, Xiang;Wang, Wendy Y.;Farrow, Emily G.;Gonzaludo, Nina;Halpern, Aaron L.;Nickerson, Deborah A.;Miller, Neil A.;Pratt, Victoria M.;Kalman, Lisa, V
• 通讯作者: Kalman, Lisa, V

Development of a Genomic Data Flow Framework: Results of a Survey Administered to NIH-NHGRI IGNITE and eMERGE Consortia Participants.

基因组数据流框架的开发：对 NIH-NHGRI IGNITE 和 eMERGE 联盟参与者进行的调查结果。

• 发表时间: 2019
• 期刊: AMIA ... Annual Symposium proceedings. AMIA Symposium
• 作者: Dexter,Paul;Ong,Henry;Elsey,Amanda;Bell,Gillian;Walton,Nephi;Chung,Wendy;Rasmussen,Luke;Hicks,Kevin;Owusu-Obeng,Aniwaa;Scott,Stuart;Ellis,Steve;Peterson,Josh
• 通讯作者: Peterson,Josh