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（由申请人提供）：血尿是膀胱癌 (BCa) 最常见的表现，22% 的患者存在肉眼血尿，8% 的患者存在镜下血尿。 空尿细胞学检查 (VUC) 是最广泛使用的尿液。 - 用于检测 BCa 的检测（和金标准）；然而，它无法检测到大约 50% 的低级或早期 BCa；此外，由于这种严重的局限性，VUC 对复发性 BCa 的检出率也没有提高很多，因此所有有血尿且接受监测以监测复发性 BCa 的患者都必须接受膀胱的侵入性检查，其中需要进行微型膀胱检查。将摄像头插入膀胱并检查膀胱，我们建议通过利用多重 ELISA 检测排泄尿液中先前验证的 BCa 相关诊断特征（特征）来改进 BCa 检测。假设 存在以下分子特征：a) 与 BCa 特异性相关，b) 可用于表明非侵入性获得的排泄尿液样本中是否存在 BCa。 该假设将通过完成以下具体目标进行检验：1) 验证。用于在出现肉眼血尿的受试者中进行 BCa 检测的多重 ELISA，2) 验证用于目前正在接受肿瘤监测的有 BCa 病史的患者的 BCa 检测的多重 ELISA，以及 3) 研究用于确定疾病风险的 BCa 相关诊断特征这项研究将为改进 BCa 检测的非侵入性方法打开大门，并将对患者护理方法产生显着影响。在本提案中，我们将在两项独立研究中测试多重 ELISA：出现肉眼血尿的患者和接受肿瘤监测的 BCa 患者。 预期结果 多重 ELISA 的验证将减少对大量受试者进行检测的需要。具体来说，我们预计每年膀胱镜检查的次数将减少 500,000 次，这将意味着每年节省 2.25 亿美元的成本。