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: 9305852
• 负责人: Robin Jean Leach
• 金额: $ 33.76万
• 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/9305852
• 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; 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; ethnic minority population; genetic variant; improved; individual patient; interest; man; men; molecular marker; outcome forecast; predictive tools; prostate biopsy; public health relevance; racial and ethnic; racial diversity; response; screening; surveillance study; tissue biomarkers; tool; tumor; unnecessary treatment; 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不再将血清前列腺特异性抗原 (PSA) 筛查作为标准临床实践。促成这一建议的一个因素是，许多通过 PSA 筛查诊断出的前列腺癌都是惰性疾病，永远不会进展。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、尿液和组织标记物验证区分惰性疾病和侵袭性疾病的标记物（目标 1 和 2）； 3) 加强风险评估，为个体患者做出明智的决策，提高他们的能力 确定活检是否符合他们的最佳利益； 4) 为主动监测的男性开发风险评估工具，以协助患者和医生做出有关活检的决策。 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方面有着悠久的历史，并对此类检测方法进行严格评估，以确保在临床使用这些检测方法时，患者能够从中受益。将使用 4000 人 SABOR 队列与其他已建立的队列（例如 SWOG PCPT 和 PASS）进行 II 期和 III 期验证研究，以提高与前列腺癌风险和长期疾病结果相关的生物标志物性能。第一个目标侧重于评估当前生物标志物的长期性能，包括 PHI、PCA3 和 TMPRSS2:ERG。这一目标还提出了对体质遗传变异的验证研究，这些变异可能会识别出癌症风险较高或疾病结果可能较差的男性。在目标 2 中，将开发组织微阵列（TMAs）来验证已发表的预后标志物。此外，将构建允许评估新的基于组织的标记物在种族/种族不同肿瘤中的性能的TMA。对于第三个目标，PCPT 风险计算器将得到完善，并开发一种新工具，以帮助接受主动监测的男性确定是否有必要进行监测活检。该中心将继续努力，向其他研究人员提供精心收集的患者样本，以帮助发现未来的测试或进行研究以确保这些测试真正帮助患者。此外，SABOR 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检测和治愈癌症的目标。