Translation of a Clinical Molecular Diagnostic Assay for Bladder Cancer

膀胱癌临床分子诊断检测的转化

基本信息

批准号：
10203860
负责人：
Steve Goodison
金额：
$ 62.69万
依托单位：
MAYO CLINIC JACKSONVILLE
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10203860
关键词：
Address Adoption Algorithms Arizona Biological Assay Biological Markers Bladder Neoplasm CLIA certified Cancer Detection Clinic Clinical Clinical Management Cystoscopy Data Detection Development Diagnosis Diagnostic Diagnostic tests Disease Ensure Evaluation FDA approved Face Florida Future Goals Gold Guidelines Hand Health Care Costs Healthcare Systems Immunoassay Industrialization Industry Infrastructure Laboratories Life Malignant Neoplasms Malignant neoplasm of urinary bladder Measurement Modality Modeling Molecular Diagnosis Molecular Diagnostic Testing Monitor Multi-Institutional Clinical Trial Newly Diagnosed Non-Invasive Cancer Detection Pain Participant Patients Performance Phase Positioning Attribute Process Prospective Studies Prospective cohort study Proteomics Quality Control Randomized Recurrence Reproducibility Research Running Sampling Site System Techniques Technology Testing Time Translating Translations Transurethral Resection Urinalysis Urine Urology Validation Work base biobank biomarker signature cancer care cancer diagnosis clinical diagnostics cohort diagnostic assay industry partner molecular diagnostics multiplex assay noninvasive diagnosis novel performance tests prospective protein biomarkers prototype quality assurance recruit research clinical testing skills translation assay tumor urinary validation studies

项目摘要

Project Summary/Abstract Bladder cancer (BCa) is among the five most common malignancies in the US and worldwide. At presentation, the majority of bladder tumors are non-muscle invasive and can be treated by transurethral resection of the tumor; however, more than 70% of patients with BCa will have a recurrence during the first two years after primary treatment. This recurrence phenomenon makes BCa one of the most prevalent cancers worldwide. Accordingly, once diagnosed, patients are under continual surveillance with routine cystoscopy for detection of new tumor development, so the healthcare costs of BCa are a major burden. The overall goal of this project is to adapt and optimize an efficient assay that can achieve the accurate, non-invasive detection of BCa via urinalysis. Using high-throughput proteomic profiling technologies and multiple validation studies, we have defined a multiplex protein biomarker signature that outperforms any currently used non-invasive approach for BCa detection. The next task is to develop a specific technology system and achieve through optimization the translation of the novel assay for clinical molecular diagnosis. To address this, we have created an academic/industry research partnership between the Mayo Clinic and Meso Scale Diagnostics. The proposal will test functionality, enable optimization, and validate the performance of the proposed assay in a real-world clinical laboratory setting. At the end of the study, we aim to have developed a non-invasive, urine-based assay for bladder cancer detection and disease status evaluation that will be of tremendous benefit to both patients and the healthcare system.

项目概要/摘要膀胱癌（BCa）是美国和全世界五种最常见的恶性肿瘤之一。在介绍时，大多数膀胱肿瘤是非肌层浸润性的，可以通过经尿道切除膀胱肿瘤来治疗。瘤;然而，超过 70% 的 BCa 患者会在术后的头两年内复发。初级治疗。这种复发现象使BCa成为全球最常见的癌症之一。因此，一旦确诊，患者将接受常规膀胱镜检查的持续监测，以检测新肿瘤的发展，因此BCa的医疗费用是一个主要负担。该项目的总体目标是调整和优化有效的检测方法，通过以下方式实现 BCa 的准确、非侵入性检测尿液分析。利用高通量蛋白质组分析技术和多项验证研究，我们定义了多重蛋白质生物标志物特征优于目前使用的任何 BCa 非侵入性方法检测。接下来的任务是开发具体的技术体系并通过优化来实现临床分子诊断新方法的转化。为了解决这个问题，我们创建了一个梅奥诊所和 Meso Scale Diagnostics 之间的学术/行业研究合作伙伴关系。提案将测试功能、实现优化并验证所提出的测定在现实世界中的性能临床实验室设置。在研究结束时，我们的目标是开发出一种基于尿液的非侵入性方法膀胱癌检测和疾病状态评估的测定对双方都有巨大的好处患者和医疗保健系统。