Fox Chase Clinical Epidemiology and Validation Center

描述（由申请人提供）：早期检测研究网络（EDRN）的使命是将新兴的分子知识转化为实际的临床测试，以检测癌症并更准确地评估癌症风险。Fox Chase癌症中心响应RFA建立临床流行病学和验证中心（CEVC）。Fox Chase将作为合作研究中使用的标本资源中心。为了建立CEVC，我们建议：1)组建一个多学科的研究团队，专注于早期发现和风险评估标记。2)与其他EDRN中心和区域机构开展有意义的合作，以促进早期研究。3)建立研究监测、方案/项目管理、质量保证和数据共享的程序。4)参与指导委员会活动，回应指导委员会的提案和建议。5)确保受试者安全，保护已获得的受试者信息。Fox Chase癌症中心提出了一项研究计划，利用Fox Chase癌症中心开发的蛋白质组学技术和检测癌症高风险患者血清中DNA超甲基化的能力，进行乳腺癌早期检测的临床生物标志物验证研究。FCCC将利用其独特的资源1)评估生物标志物在预测疾病程度或严重程度方面的准确性。2)评价基因与环境的相互作用。3)了解高风险人群的风险和易感性；4)识别并处理在Fox Chase附属登记处和肿瘤库登记的独特高风险人群。

DESCRIPTION (provided by applicant): The mission of the Early Detection Research Network (EDRN) is to translate newly emerging molecular knowledge into practical clinical tests to detect cancer and to more accurately evaluate cancer risk. Fox Chase Cancer Center is responding to the RFA to establish a clinical epidemiology and validation center (CEVC). Fox Chase will serve as a resource center for specimens for use in collaborative research. In order to establish a CEVC we propose: 1) To assemble a multidisciplinary team of investigators focused on early detection and risk assessment markers. 2) To develop meaningful collaborations with other EDRN centers and with regional institutions to foster early phase studies. 3) To establish procedures for study monitoring, managing protocols/projects as well as quality assurance and data sharing. 4) To participate in steering committee activities and respond to steering committee proposals and suggestions. 5) To assure subject safety and to protect information acquired on participating subjects. Fox Chase Cancer Center proposes a research plan for clinical biomarker validation studies for early detection of breast cancer utilizing proteomic techniques developed at Fox Chase Cancer Center and capability of detecting DNA hypermethylation in serum in patients at high risk for cancer. FCCC will use its unique resources 1) to assess the accuracy of biomarkers in predicting extent or severity of disease. 2) to evaluate gene environmental interactions. 3) to understand risks and susceptibility in high risk cohorts and 4) to identify and work with unique high risk populations that are enrolled in Fox Chase affiliated registries and tumor banks.