San Antonio Center for Biomarkers of Risk for Prostate Cancer (SABOR)

圣安东尼奥前列腺癌风险生物标志物中心 (SABOR)

• 批准号: 8996921
• 负责人: Robin Jean Leach
• 金额: $ 10万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-05-15 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8996921
• 关键词: Address; Advisory Committees; Aging; American; Assessment tool; Biological Markers; Biopsy; Blood; Cancer Burden; Cancer Detection; Cancer Etiology; Cessation of life; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Communities; Complement; Constitutional; DNA; Decision Making; Detection; Development; Disease; Disease Outcome; Early Detection Research Network; Early Diagnosis; Eligibility Determination; Ensure; Ethnic group; Evaluation; FASN gene; FOLH1 gene; Future; Genetic Polymorphism; Goals; Human Resources; Indolent; Laboratory Scientists; Lead; Leadership; Life; Malignant Neoplasms; Malignant neoplasm of prostate; Minority; Nuclear; Online Systems; Outcome; Outcome Assessment; Patients; Performance; Phase; Physicians; Population Heterogeneity; Positioning Attribute; Preventive; Preventive service; Prognostic Marker; Prostate; Prostate Cancer Prevention Trial; Prostate specific antigen measurement; Prostate-Specific Antigen; Prostatic Neoplasms; Publishing; Race; Recommendation; Recording of previous events; Reporting; Research Personnel; Resources; Risk; Risk Assessment; Risk Marker; SP1 gene; Sampling; Screening for Prostate Cancer; Selenium and Vitamin E Efficacy Trial; Series; Serinus; Serum; Services; Southwest Oncology Group; Specimen; Stress; TMPRSS2 gene; Testing; Time; Tissue Microarray; Tissues; Tumor-Derived; Urine; Urologist; Urology; Validation; Work; base; biomarker development; cancer diagnosis; cancer risk; clinical practice; cohort; disorder risk; ethnic diversity; factor A; genetic variant; improved; individual patient; interest; man; men; molecular marker; outcome forecast; prostate biopsy; public health relevance; response; screening; surveillance study; tissue biomarkers; tool; tumor; urologic; validation studies

 DESCRIPTION (provided by applicant): Prostate cancer is the most common non-cutaneous cancer in American men. In May of 2012, the U.S. Preventive Task Force recommended that serum prostate specific antigen (PSA) screening no longer be recommended as standard clinical practice. A factor contributing to this recommendation is that many prostate cancers diagnosed via PSA-screening are indolent disease that will never progress. Current American Urologic Association recommendations stress informed decision making. To this end, this Clinical Validation Center will address the following major unmet clinical needs: 1) Optimize serum PSA screening protocols to identify men with aggressive diseases and reduce screening and detection of men with low risk disease (aim 1); 2) Validate markers that distinguish indolent versus aggressive disease using serum, DNA, urine, and tissue markers (aims 1 and 2); 3) Enhancing risk assessment for informed decision for individual patients, improving their ability to determine if a biopsy is in their best interest; 4) Develop a risk assessment tool for men on active surveillance to assist patients and physicians with decision making regarding biopsy. The SABOR EDRN Clinical Validation Center, established in 2000, has a long history of development of new tests for prostate cancer and critically evaluating such tests to ensure that, if they are used in the clinic, patients benefit from their use. Using the 4000-man SABOR cohort with other established cohorts (e.g., SWOG PCPT and PASS), Phase II and III validation studies will be conducted to improve biomarker performance related to prostate cancer risk and long term disease outcomes. The first aim focuses on assessing long term performance of current biomarkers including PHI, PCA3 and TMPRSS2:ERG. Also proposed in this aim are validation studies of constitutional genetic variants that may identify men at greater cancer risk or who are more likely to have poor disease outcomes. In aim 2, tissue microarrays (TMAs) will be developed for validating published markers of prognosis. In addition, TMAs that allow evaluation of performance of new tissue-based markers in ethnical/racial diverse tumors will be constructed. For the third aim, the PCPT risk calculator will be refined and a new tool developed to help men on active surveillance determine if a surveillance biopsy is necessary. The Center will continue its work to provide carefully-collected samples from patients to other investigators to either help discover the tests of the future or to conduct studies to ensure that the tests trul help patients. In addition, the SABOR scientific personnel will continue to provide service in leadership positions of the EDRN to ensure that the entire Network accelerates toward the goal of successful early detection and cure of cancer.

 描述（由申请人提供）：前列腺癌是美国男性中最常见的非皮肤癌。2012年5月，美国预防工作组建议血清前列腺特异性抗原（PSA）筛查不再被推荐为标准临床实践。促成这一建议的一个因素是，许多通过PSA筛查诊断的前列腺癌是永远不会进展的惰性疾病。目前美国泌尿外科协会的建议强调知情决策。为此，该临床验证中心将解决以下主要未满足的临床需求：1）优化血清PSA筛查方案，以识别患有侵袭性疾病的男性，并减少对患有低风险疾病的男性的筛查和检测（目标1）; 2）使用血清、DNA、尿液和组织标记物来识别区分惰性与侵袭性疾病的标记物（目标1和2）; 3）加强风险评估，让个别病人在知情的情况下作出决定，提高他们的能力， 确定活检是否符合他们的最佳利益; 4）为积极监测的男性开发风险评估工具，以帮助患者和医生做出关于活检的决策。SABOR EDRN临床验证中心成立于2000年，在开发前列腺癌新检测方法和严格评估此类检测方法方面有着悠久的历史，以确保如果将其用于临床，患者将从中受益。使用4000人SABOR队列和其他已建立的队列（例如，SWOG PCPT和PASS）、II期和III期验证研究，以改善与前列腺癌风险和长期疾病结局相关的生物标志物性能。第一个目标集中于评估当前生物标志物的长期性能，包括PHI、PCA 3和TMPRSS 2：ERG。在这一目标中还提出了对体质遗传变异的验证研究，这些研究可能会识别出癌症风险更高或更有可能出现不良疾病结果的男性。在目标2中，将开发组织微阵列（TMA）用于验证已发表的预后标志物。此外，将构建允许评价新的基于组织的标志物在种族/种族多样性肿瘤中的性能的TMA。对于第三个目标，PCPT风险计算器将得到改进，并开发一种新的工具，以帮助积极监测的男性确定是否有必要进行监测活检。该中心将继续其工作，向其他研究人员提供从患者身上仔细收集的样本，以帮助发现未来的测试或进行研究，以确保测试真正帮助患者。此外，SABOR的科研人员将继续在EDRN的领导岗位上提供服务，以确保整个网络加速实现成功早期发现和治愈癌症的目标。