MULTIPLEXED PROTEIN BIOMARKER-BASED ASSAY FOR THE DETECTION OF BLADDER CANCER

用于检测膀胱癌的多重蛋白质生物标志物检测

• 批准号: 9267137
• 负责人: Charles J Rosser
• 金额: $ 59.53万
• 依托单位: UNIVERSITY OF HAWAII AT MANOA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-01 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9267137
• 关键词: American; Biological Assay; Biological Markers; Bladder; Blood; Cancer Detection; Cancer Patient; Clinical Data; Complex; Cost Savings; Cystoscopy; Cytology; Data; Data Set; Detection; Diagnostic; Disease; Enzyme-Linked Immunosorbent Assay; European; Evaluation; Gene Expression; Gene Expression Profiling; Goals; Gold; Health Care Costs; Healthcare; Hematuria; Individual; Intervention; Investigation; Link; Longitudinal cohort; Malignant Neoplasms; Malignant neoplasm of urinary bladder; Measurement; Methodology; Methods; Microscopic; Modeling; Molecular; Molecular Profiling; Monitor; National Comprehensive Cancer Network; Outcome; Patient Care; Patients; Performance; Prospective cohort; Protocols documentation; Publishing; Recommendation; Recording of previous events; Recurrence; Research; Risk; Sampling; Specificity; Techniques; Testing; Time; Translating; Tumor stage; Urine; Urology; Validation; base; cohort; cost; design; disorder risk; improved; individual patient; innovation; molecular diagnostics; patient stratification; prospective; protein biomarkers; public health relevance; tumor; urinary; urologic

 DESCRIPTION (provided by applicant): Hematuria is the most common presentation of bladder cancer (BCa) with 22% of patients with gross hematuria and 8% of patients with microscopic hematuria harboring BCa. Voided urinary cytology (VUC) is the most widely used urine-based assay (and gold standard) for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients with hematuria and who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected. We propose to improve the detection of BCa by utilizing a multiplex ELISA for the detection of a previously validated BCa- associated diagnostic signature (signature) in voided urine. Hypothesis A molecular profile exists that a) is specificall associated with BCa and b) can be utilized to indicate the presence of BCa in non-invasively obtained voided urine samples. This hypothesis will be tested by completing the following Specific Aims: 1) To validate the multiplex ELISA for BCa detection in subjects presenting with gross hematuria, 2) To validate the multiplex ELISA for BCa detection in patients with a history of BCa currently undergoing tumor surveillance and 3) To investigate the ability of the BCa-associated diagnostic signature to determine risk of disease. Significance This research will open the door for improving on the non-invasive methods for detecting BCa and will have a marked impact on patient care. Methodology Our group has developed and tested a multiplex ELISA towards this signature. In this proposal, we will test the multiplex ELISA in 2 independent studies: patients presenting with gross hematuria and BCa patients undergoing tumor surveillance. Expected Results The validation of the multiplex ELISA will reduce the need to subject large numbers of patients who do not have BCa to frequent, uncomfortable and expensive cystoscopic examinations. Specifically, we would anticipate a reduction in the number of cystoscopies/year by 500,000, which would translate into cost savings of $225 million/year.

 描述（由适用提供）：血尿是膀胱癌（BCA）最常见的表现，其中22％的总血尿病患者和8％的微观血尿具有BCA患者。无效的尿细胞学（VUC）是用于检测BCA的最广泛使用的尿液评估（和金标准）；但是，当最可治愈时，它无法检测到大约50％的低级或早期BCA。此外，复发性BCA的VUC的检测率并不高。由于这种严重的局限性，所有血尿和正在监视以监测复发性BCA的患者都必须对尿中膀胱进行侵入性检查，在该检查中，将微型摄像头插入了膀胱和检查器检查中。我们建议通过利用多重ELISA来检测VAIRINE尿液中先前验证的BCA相关诊断（签名）来改善BCA的检测。假设一个分子曲线存在a）特定于BCA和b）可以用来指示在非侵入性获得的无效尿液样品中存在BCA。该假设将通过完成以下具体目的来检验：1）在出现毛血状的受试者中验证BCA检测的多重ELISA，2）2）以验证BCA目前正在接受肿瘤监测的BCA患者的BCA检测的多重ELISA，以确定BCA疗法的诊断风险的能力，以确定BCA症状的能力。意义上这项研究将为改善检测BCA的非侵入性方法开辟大门，并对患者护理产生明显影响。方法论我们的小组已经开发并测试了一个多重ELISA针对此签名。在此提案中，我们将在2项独立研究中测试多重ELISA：呈现肿瘤监测的患者和BCA患者。预期的结果验证多重ELISA将减少对没有BCA经常，不舒服且昂贵的膀胱镜检查的大量患者的需求。具体来说，我们预计膀胱镜工程的数量会减少500,000，这将转化为每年节省2.25亿美元的成本。