Aurora Kinase A as a Biomarker for the Detection of Bladder Cancer

极光激酶 A 作为检测膀胱癌的生物标志物

• 批准号: 8287655
• 负责人: BOGDAN A CZERNIAK
• 金额: $ 39.08万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-06 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8287655
• 关键词: Affect; Bedside Testings; Biological Markers; Biopsy; Bladder; Bladder Neoplasm; Cancer Detection; Cell physiology; Cessation of life; Clinical; Clinical Oncology; Cost Effective Management; Cystoscopy; Cytology; Detection; Development; Diagnosis; Diagnostic; Diagnostic Trial; Disease; Early Detection Research Network; Early Diagnosis; Early treatment; Frequencies; Funding; Goals; Grant; Healthcare; Hematuria; Human; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of urinary bladder; Modeling; Monitor; Nomograms; Occupations; Patients; Performance; Positioning Attribute; Protocols documentation; Reproducibility; Role; Sampling; Sensitivity and Specificity; Survival Rate; Techniques; Testing; Treatment Effectiveness; United States; Urine; Validation; Western World; aurora-A kinase; base; clinical practice; clinically significant; commercialization; compare effectiveness; high risk; human STK6 protein; improved; men; minimally invasive; novel; patient population; prognostic; public health relevance; tumor progression

DESCRIPTION (provided by applicant): The long-term objective of this project is to improve the detection of one of the common human cancers arising in the bladder by non-invasive voided urine-based tests. Bladder cancer is the 4th most common cancer in men and 5th most common overall with an approximately 68,800 new cases and 14,100 deaths from the disease in 2008 in the United States. It is estimated that nearly 300,000 patients are regularly monitored in the United States through a variety of non-invasive (urine) and minimally invasive (bladder barbotage, cystoscopy, and biopsy) techniques. Therefore, the development of novel biomarkers that can detect bladder tumors by a non-invasive approach is of major clinical significance. In this grant we propose to validate aurora A FISH test as a biomarker for the detection of bladder cancer in the multi-institutional validation protocol. In this protocol, we will compare the specificity and sensitivity of aurora A FISH test with other known noninvasive bladder cancer detection tests for voided urine sediments such as urine cytology and commercially available multi-chromosomal FISH kit known as UroVysion, and NMP22 point-of-care test. The specific aims for this proposal are as follows: Specific Aim 1: Determine the reproducibility of the Aurora A FISH test. Specific Aim 2: Validate a model for BC detection in patients with hematuria and determine if Aurora A FISH and/or UroVysion FISH improves the model. A previously described nomogram incorporating clinical variables and NMP22 will be validated. Furthermore, the Aurora A FISH and UroVysion FISH tests will be assessed for their ability to improve the current nomogram. Specific Aim 3: Determine the ability of Aurora A FISH to detect BC and determine its performance with cytology, UroVysion FISH, and NMP22. The sensitivity and specificity of Aurora A FISH will be determined. The performance of Aurora A FISH will be compared with cytology, UroVysion FISH as well as NMP22 and the ability of a combination of markers to improve detection will be explored. Specific Aim 4: Determine the ability of Aurora A FISH to detect patients with BC who are at high risk of tumor progression. Aurora A FISH performance will be compared with that of cytology, UroVysion FISH, and NMP22. PUBLIC HEALTH RELEVANCE: In this grant we propose to validate aurora A FISH test as a biomarker for the detection of bladder cancer in the multi-institutional validation protocol and compare it with urine cytology, UroVysion FISH, and NMP22 tests. Given the high frequency of bladder cancer, the development of a specific and sensitive test for the disease by a non-invasive approach will have a great impact on its cost effective management. The clinical use of such a test will represent a novel standard of practice facilitating early treatment of bladder cancer and positively affecting the survival rates of the patients with bladder cancer.

描述(由申请人提供)：该项目的长期目标是通过非侵入性排尿检测来提高对膀胱癌的检测。膀胱癌是男性第四大常见癌症，也是第五大常见癌症，2008年美国新增约68,800例膀胱癌病例和14,100例死亡病例。据估计，美国有近300,000名患者通过各种非侵入性(尿液)和微创(膀胱镜、膀胱镜和活检)技术进行定期监测。因此，开发新型的非侵入性检测膀胱癌的生物标志物具有重要的临床意义。在这笔赠款中，我们建议在多机构验证方案中验证AURORA A FISH测试作为检测膀胱癌的生物标记物。在这项方案中，我们将比较AURORA A FISH检测与其他已知的尿液沉渣非侵入性膀胱癌检测测试的特异性和敏感性，例如尿细胞学和商业上可获得的多染色体FISH试剂盒UroVysion，以及NMP22点检测。这项建议的具体目标如下：具体目标1：确定Aurora A鱼类试验的重现性。具体目标2：验证血尿患者的BC检测模型，并确定Aurora A FISH和/或UroVysion FISH是否改进了该模型。之前描述的包含临床变量和NMP22的诺模图将得到验证。此外，将评估Aurora A FISH和UroVysion FISH测试改善当前诺模图的能力。具体目标3：确定Aurora A FISH检测BC的能力，并用细胞学、UroVysion FISH和NMP22确定其性能。Aurora A鱼类的敏感性和特异性将被确定。Aurora A FISH的性能将与细胞学、UroVysion FISH以及NMP22进行比较，并将探索组合标记提高检测的能力。具体目标4：确定Aurora A FISH检测具有高肿瘤进展风险的BC患者的能力。Aurora A FISH的表现将与细胞学、UroVysion FISH和NMP22进行比较。 公共卫生相关性：在这项赠款中，我们建议在多机构验证方案中验证AURORA A FISH测试作为检测膀胱癌的生物标记物，并与尿液细胞学、UroVysion FISH和NMP22测试进行比较。鉴于膀胱癌的发病率很高，通过非侵入性方法开发一种特异和敏感的检测方法将对膀胱癌的成本效益管理产生重大影响。这种检测方法的临床应用将代表着一种新的实践标准，有助于膀胱癌的早期治疗，并对膀胱癌患者的生存率产生积极影响。