Translation of a Clinical Molecular Diagnostic Assay for Bladder Cancer

膀胱癌临床分子诊断检测的转化

• 批准号: 9980305
• 负责人: Steve Goodison
• 金额: $ 62.28万
• 依托单位: MAYO CLINIC JACKSONVILLE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9980305
• 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; 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; cancer care; cancer diagnosis; clinical diagnostics; cohort; diagnostic assay; industry partner; molecular diagnostics; noninvasive diagnosis; novel; performance tests; prospective; protein biomarkers; prototype; quality assurance; recruit; research clinical testing; skills; translation assay; tumor; urinary; validation studies

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.

项目总结/摘要 膀胱癌（BCa）是美国和全球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肉侵入性的，可以通过经尿道切除膀胱肿瘤来治疗。 肿瘤;然而，超过70%的BCa患者在术后的前两年会复发。 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，以检测膀胱癌。 新的肿瘤发展，因此BCa的医疗保健费用是一个主要负担。该项目的总体目标是 调整和优化一种有效的检测方法，通过以下方式实现BCa的准确、非侵入性检测： 尿检 使用高通量蛋白质组学分析技术和多重验证研究，我们定义了一个 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 侦测下一步的任务是开发一个特定的技术系统，并通过优化实现 用于临床分子诊断的新测定的翻译。为了解决这个问题，我们创建了一个 马约诊所和Meso Scale Diagnostics之间的学术/行业研究伙伴关系。该提案 将测试功能，实现优化，并在现实世界中验证拟议检测试剂盒的性能 临床实验室设置。在研究结束时，我们的目标是开发出一种非侵入性的、基于尿液的 用于膀胱癌检测和疾病状态评估的分析，这将对两者都有巨大的好处。 患者和医疗系统。