Validation of Imaging and Blood-based Small Vessel VCID Biomarkers in Multiethnic Population

多种族人群中影像学和基于血液的小血管 VCID 生物标志物的验证

基本信息

批准号：
10611821
负责人：
Amir H Kashani
金额：
$ 129.03万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2026-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10611821
关键词：
Validation Imaging Blood based Small

项目摘要

PROJECT SUMMARY/ABSTRACT The MarkVCID consortium was established in 2016 to pursue the initial stages of multi-site validation of 7 imaging-based and 4 fluid-based candidate biomarkers for small vessel vascular contributions to cognitive impairment and dementia (VCID). As one of the 7 participating sites, our team at the University of Southern California (USC) has analyzed and optimized candidate VCID biomarkers during the UH2 phase (years 1-2) and participated in the consortium-wide program of biomarker scaling-up, multi-site protocol implementation, and initial multi-site validation during the UH3 phase (years 3-5). USC has led the consortium-wide development and implementation of the optical coherence tomography angiography (OCTA) biomarker kit which is based on an FDA-approved device that allows in vivo and completely noninvasive imaging of retinal capillaries with a spatial resolution of ~10 microns. We have also participated in the validation of the other 6 MRI based candidate biomarkers while contributing blood samples for the validation of the 3 plasma-based candidate biomarkers. The primary objective of the next 5 years is to carry out comprehensive multi-site clinical validation of candidate VCID biomarkers in longitudinal studies of diverse populations that are typical in clinical settings in the US. Capitalizing on the high racial diversity in Los Angeles, we plan to enroll a multiethnic longitudinal cohort of at least 200 subjects that are enriched for small vessel VCID, including 100 Latinx subjects from the Los Angeles Latino Eye Study (LALES), 50 African Americans (AAs) enrolled in the African American Eye Disease Study (AFEDS), and 50 Caucasian participants from the Clinical Core of the USC ADRC. We have performed pilot studies in both Latinx and AA subjects (the two largest minority groups in the US) using MarkVCID protocols to show the feasibility of conducting such studies in a multiethnic cohort. We have also built a multiethnic team of investigators, technical staff, research coordinators, and community outreach staff to streamline enrollment, achieve the recruitment milestones, and perform longitudinal follow-up studies. Our team includes established expertise, equipment and infrastructure for OCTA, MRI, fluid biomarker and clinical/cognitive evaluation of VCID, as well as a proven track record in the sharing of de-identified clinical data through the Laboratory of Neuro Imaging (LONI) for the second phase of MarkVCID project.

项目概要/摘要 MarkVCID 联盟成立于 2016 年，旨在对 7 种基于成像和 4 种基于液体的候选生物标志物进行多中心验证的初始阶段，以了解小血管对认知障碍和痴呆 (VCID) 的影响。作为 7 个参与地点之一，我们南加州大学 (USC) 的团队在 UH2 阶段（第 1-2 年）分析和优化了候选 VCID 生物标志物，并参与了联盟范围内的生物标志物扩大计划，多站点协议实施，以及 UH3 阶段（第 3-5 年）的初始多站点验证。南加州大学领导了整个联盟范围内光学相干断层扫描血管造影 (OCTA) 生物标记试剂盒的开发和实施，该试剂盒基于 FDA 批准的设备，可对视网膜毛细血管进行体内完全无创成像，空间分辨率约为 10 微米。我们还参与了其他 6 个基于 MRI 的候选生物标志物的验证，同时提供血液样本以验证 3 个基于血浆的候选生物标志物。未来 5 年的主要目标是在美国临床环境中典型的不同人群的纵向研究中对候选 VCID 生物标志物进行全面的多中心临床验证。利用洛杉矶高度的种族多样性，我们计划招募至少 200 名多种族纵向队列受试者，这些受试者经过小血管 VCID 丰富，其中包括 100 名来自洛杉矶拉丁裔眼科研究 (LALES) 的拉丁裔受试者、50 名非裔美国人 ( AA）参加了非裔美国人眼病研究 (AFEDS)，还有 50 名来自南加州大学 ADRC 临床核心的白人参与者。我们使用 MarkVCID 方案对拉丁裔和 AA 受试者（美国两个最大的少数群体）进行了试点研究，以展示在多种族队列中进行此类研究的可行性。我们还建立了一支由研究人员、技术人员、研究协调员和社区外展人员组成的多种族团队，以简化招募流程、实现招募里程碑并进行纵向后续研究。我们的团队包括 OCTA、MRI、液体生物标志物和 VCID 临床/认知评估的成熟专业知识、设备和基础设施，以及通过神经影像实验室 (LONI) 共享去识别化临床数据的良好记录。 MarkVCID项目第二期。