Fox Chase Clinical Epidemiology and Validation Center

描述（由申请人提供）：早期检测研究网络（EDRN）的使命是将新出现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癌症中心正在响应RFA，建立临床流行病学和验证中心（CEVC）。福克斯大通将作为一个资源中心的标本用于合作研究。为了建立CEVC，我们建议：1）组建一个多学科的研究团队，专注于早期检测和风险评估标志物。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)建立研究监查、管理方案/项目以及质量保证和数据共享的程序。4)参与指导委员会的活动，并对指导委员会的提议和建议作出回应。5)确保受试者安全并保护所获得的参与受试者信息。Fox Chase癌症中心提出了一项临床生物标志物验证研究的研究计划，用于利用Fox Chase癌症中心开发的蛋白质组学技术和检测癌症高危患者血清中DNA超甲基化的能力早期检测乳腺癌。FCCC将利用其独特的资源1）评估生物标志物在预测疾病范围或严重程度方面的准确性。2)来评估基因与环境的相互作用。3)了解高风险队列的风险和易感性，以及4）识别并与Fox Chase附属登记处和肿瘤库中招募的独特高风险人群合作。

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.