Secure Web-Based Flow Cytometry in Clinical Use and Translational Research

临床使用和转化研究中安全的基于网络的流式细胞术

• 批准号: 8253426
• 负责人: Nikesh Kotecha
• 金额: $ 26.85万
• 依托单位: CYTOBANK, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-01 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8253426
• 关键词: AIDS/HIV problem; Address; Autoimmune Diseases; Autoimmunity; Back; Biological Assay; Blinded; Blood; Cells; Child; Clinic; Clinical; Clinical Data; Clinical Research; Communities; Complex; Complex Mixtures; Computational algorithm; Computer software; Custom; Cytometry; Data; Data Analyses; Data Files; Development; Diagnosis; Disease; Electronics; Ensure; Financial compensation; Flow Cytometry; Fluorescence; Follicular Lymphoma; Goals; Grant; Health; Hematopoietic Neoplasms; Hospitals; Human; Imagery; Immune Tolerance; Immunologic Monitoring; Immunology; Individual; Industry; Information Protection; Internet; Laboratories; Laboratory Research; Letters; Lymphoma; Malignant Neoplasms; Manuals; Manufacturer Name; Measures; Online Systems; Pathology; Patient Monitoring; Patients; Phase; Population; Process; Provider; Reagent; Records; Regulation; Reporting; Research Personnel; Sampling; Secure; Security; Signal Pathway; Software Tools; Specimen; Statistical Data Interpretation; Stem Cell Research; Stem cells; System; Technology; Testing; Time; Tissues; Translating; Translational Research; Universities; Work; aggressive therapy; base; cancer diagnosis; circulating cancer cell; clinical Diagnosis; data management; data sharing; global health; human disease; innovation; insight; instrument; medical schools; peripheral blood; physical separation; prognostic; repository; research study; stem; therapy resistant; tool; tumor; web-accessible

DESCRIPTION (provided by applicant): The ability of flow cytometry to measure 30 or more parameters on individual cells makes it a perfect tool for analyzing complex mixtures of cells such as peripheral blood or tumor sample from patients with various diseases. New assays have enabled researchers to measure signaling pathways inside individual cells, providing insight into the pathology of cancers and immunological disorders. Cytobank is a web--‐based software platform for the management, sharing, and analysis of flow cytometry data, providing end users with the ability to generate complex data visualizations such as heatmaps directly from raw flow cytometry data. Currently, multiple software platforms are required for fully analyzing and disseminating data from flow cytometers, therefore making it difficult to comply with the strict requirements of patient information protection regulations. In this grant, we will extend the capabilities of Cytobank by ensuring compliance with 21 CFR Part 11 and developing templates for commonly performed clinical assays. This will allow clinical researchers to move cutting edge flow cytometry assays into the clinic, as they will be able to securely share data with approved individuals who can assist in data analysis and statistical interpretation. The Aims of the grant are to 1) implement an electronic signature for records in Cytobank, 2) create an audit trail for all steps of data management and analysis, and 3) create analysis templates for routine analyses in clinical immune monitoring and translational research in cancer. The ultimate goal of making Cytobank clinically compliant is to enhance global health by enabling more efficient translation of research findings into clinical settings, primarily by connecting clinicians and researchers via a simple to use interface for data management and analysis. PUBLIC HEALTH RELEVANCE: Flow cytometry is used in clinical research and for diagnosis and monitoring of patients with diseases ranging from cancer to autoimmunity. In this grant, we propose to enhance a previously built web-based software analysis suite, called Cytobank, to make all aspects of data management and analysis clinically compliant under 21 CFR Part 11. This will enable important new tools developed in the research laboratory to be translated into clinical settings and enhance patient treatment with cutting edge flow cytometry assays.

描述（由申请人提供）：流式细胞术能够测量单个细胞上的30个或更多参数，这使其成为分析复杂细胞混合物（如各种疾病患者的外周血或肿瘤样本）的完美工具。新的检测方法使研究人员能够测量单个细胞内的信号通路，从而深入了解癌症和免疫性疾病的病理学。Cytobank是一个基于Web的软件平台，用于管理、共享和分析流式细胞术数据，为最终用户提供直接从原始流式细胞术数据生成复杂数据可视化（如热图）的能力。目前，需要多个软件平台来全面分析和传播来自流式细胞仪的数据，因此难以遵守患者信息保护法规的严格要求。在这项资助中，我们将通过确保符合21 CFR第11部分并为常用的临床检测开发模板来扩展Cytobank的能力。这将使临床研究人员能够将最先进的流式细胞仪检测技术引入临床，因为他们将能够与经批准的个人安全地共享数据，这些个人可以协助数据分析和统计解释。该补助金的目的是1）为Cytobank中的记录实施电子签名，2）为数据管理和分析的所有步骤创建审计跟踪，以及3）为临床免疫监测和癌症转化研究中的常规分析创建分析模板。使Cytobank符合临床要求的最终目标是通过更有效地将研究结果转化为临床环境来增强全球健康，主要是通过简单易用的数据管理和分析界面将临床医生和研究人员联系起来。 公共卫生相关性：流式细胞术用于临床研究以及诊断和监测患有从癌症到自身免疫性疾病的患者。在这项资助中，我们建议增强以前建立的基于网络的软件分析套件，称为Cytobank，使数据管理和分析的各个方面符合21 CFR第11部分的临床要求。这将使研究实验室开发的重要新工具能够转化为临床环境，并通过最先进的流式细胞术检测增强患者治疗。