Vasculitis Clinical Research Network (VCRN)

血管炎临床研究网络 (VCRN)

• 批准号: 6941107
• 负责人: PETER A MERKEL
• 金额: $ 125万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6941107
• 关键词: biomedical facility; clinical research; cooperative study; human subject; medical outreach /case finding; orphan disease /drug; patient /disease registry; vasculitis

DESCRIPTION (provided by applicant): AIM 1. Establish a multicenter Vasculitis clinical Research Network (VCRN) to foster and facilitate clinical investigation in the inflammatory vasculitides. The 4 major US vasculitis centers (Boston University, Cleveland Clinic, Johns Hopkins, and Mayo Clinic) will combine their clinical and research expertise with the resources of the General Clinical Research Centers at each site to form the core of the Network. Additionally, the combined strengths of several domestic and foreign secondary centers will be incorporated into the Network. The VCRN would serve as the focal point for vasculitis research in the United States and internationally for both clinical investigators and patients. To achieve this aim, the following activities are proposed: 1.1 Develop a clinical data repository in collaboration with other Rare Disease Clinical Research Networks and the Rare Disease Data and Technology Coordinating Center. 1.2 Build a vasculitis clinical specimen bank for storage of serum, plasma, DNA and tissue samples linked to the clinical data repository. 1.3 Enact a national recruitment program in cooperation with various vasculitis patient advocacy groups. 1.4 Utilize the extensive resources of the General Clinical Research Centers at each Primary Network Site AIM 2. Conduct a series of related longitudinal studies of novel biomarkers of vasculitis disease activity. Utilizing the VCRN Clinical Data Repository and Clinical Specimen Bank and in coordination with biostatistical support from the Data and Technology Coordinating Center, the VCRN Biomarkers Project will use several promising techniques to develop new markers of disease activity including: 2.1 Proteomics 2.2 Molecular Markers of Oxidative Stress and Inflammation 2.3 Additionally, this program will be established in a fashion that would easily allow for testing of future novel biomarkers by investigators both within and beyond the Network. AIM 3. Utilize the VCRN and patient base to conduct Phase I and II clinical trials within the proposed grant period and create the infrastructure to greatly facilitate the design and performance of other future trials. AIM 4. Establish the Vasculitis Clinical Investigator Fellowship as a core mission on the VCRN to provide a mechanism to support, train, and mentor fellows interested in establishing academic careers focused on vasculitis research. This aim will address the pressing need in academic medicine for the training and retaining of patient oriented clinical investigators. AIM 5. Build and contribute to an electronic website resource with substantive content for clinicians, researchers, and patients.

描述（由申请人提供）： 目的 1. 建立多中心血管炎临床研究网络（VCRN），以促进和促进炎症性血管炎的临床研究。美国四大血管炎中心（波士顿大学、克利夫兰诊所、约翰霍普金斯大学和梅奥诊所）将把他们的临床和研究专业知识与每个地点的普通临床研究中心的资源结合起来，形成该网络的核心。此外，还将整合国内外多个二级中心的优势并纳入该网络。 VCRN 将成为美国和国际临床研究人员和患者血管炎研究的焦点。为实现这一目标，建议开展以下活动： 1.1 与其他罕见病临床研究网络和罕见病数据和技术协调中心合作开发临床数据存储库。 1.2 建立血管炎临床标本库，用于存储与临床数据存储库相连的血清、血浆、DNA和组织样本。 1.3 与各个血管炎患者倡导团体合作制定全国招募计划。 1.4 利用每个主要网络站点的综合临床研究中心的广泛资源 目标 2. 对血管炎疾病活动的新型生物标志物进行一系列相关的纵向研究。 利用 VCRN 临床数据存储库和临床样本库，并与数据和技术协调中心的生物统计支持相协调，VCRN 生物标志物项目将使用几种有前途的技术来开发疾病活动的新标志物，包括： 2.1 蛋白质组学 2.2 氧化应激和炎症的分子标志物 2.3 此外，该计划的建立方式将允许网络内外的研究人员轻松测试未来的新型生物标志物。 目标 3. 利用 VCRN 和患者基础在拟议的资助期内进行 I 期和 II 期临床试验，并创建基础设施以极大地促进其他未来试验的设计和执行。 目标 4. 建立血管炎临床研究者奖学金作为 VCRN 的核心使命，以提供一种机制来支持、培训和指导有兴趣建立专注于血管炎研究的学术职业的研究员。这一目标将解决学术医学中培训和保留以患者为导向的人才的迫切需求。 临床研究者。 目标 5. 为临床医生、研究人员和患者建立并贡献包含实质性内容的电子网站资源。