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

基本信息

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
项目类别：
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

项目摘要

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的 30 个或更多参数，这使其成为分析复杂的细胞混合物（例如来自患有各种疾病的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疾病的病理学。 Cytobank 是一个基于网络的软件平台，用于管理、共享和分析流式细胞术数据，使最终用户能够直接从原始流式细胞术数据生成复杂的数据可视化，例如热图。目前，需要多个软件平台来全面分析和传播流式细胞仪的数据，因此难以遵守患者信息保护法规的严格要求。在这笔拨款中，我们将通过确保遵守 21 CFR 第 11 部分并为常用的临床检测开发模板来扩展 Cytobank 的功能。这将使临床研究人员能够将最先进的流式细胞术分析转移到诊所，因为他们将能够与可以协助数据分析和统计解释的批准个人安全地共享数据。赠款的目的是 1) 在 Cytobank 中实施记录电子签名，2) 为数据管理和分析的所有步骤创建审计跟踪，3) 创建用于临床免疫监测和转化研究中常规分析的分析模板癌症。使 Cytobank 符合临床要求的最终目标是通过将研究成果更有效地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连接临床医生和研究人员。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等疾病的患者。在这笔拨款中，我们建议增强之前构建的基于网络的软件分析套件（称为 Cytobank），以使数据管理和分析的各个方面都符合 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尖端的流式细胞术检测增强患者治疗。