Fox Chase Clinical Epidemiology and Validation Center

描述（由申请人提供）：早期检测研究网络 (EDRN) 的总体目标是： a) 识别癌症风险、早期检测、分子诊断和早期癌症预后的生物标志物； b) 协调生物标志物研究和治疗策略，以降低癌症发病率和死亡率。作为临床验证中心 (CVC)，福克斯蔡斯癌症中心 (FCCC) 将： 1) 维持 FCCC 生物标志物验证研究人员多学科团队； 2) 遵守EDRN合作协议的条款和条件，包括数据共享； 3) 与 EDRN 生物标志物开发实验室 (BDL)、生物标志物参考实验室 (BRL)、CVC 以及数据管理和协调中心 (DMCC) 合作； 4) 参加 EDRN 指导委员会和科学会议和活动以及 EDRN 乳腺癌/卵巢癌联盟小组； 5) 收集、储存和分发组织、血清和 DNA，用于生物标志物发现和验证研究，尤其是有乳腺癌和卵巢癌风险的女性； 6) 与盖辛格医疗中心合作开发基于人群的生物标志物研究验证研究。 FCCC-EDRN-CVC 提议一项由研究者发起的蛋白质组学和 DNA 甲基化 II 期生物标志物验证研究项目，对象是患有良性乳腺疾病 (BBD) 且有浸润性癌症风险的女性。这项研究利用了过去五年 EDRN 资助期间收集的生物样本。目标如下：研究 1，BBD 中候选蛋白质组生物标志物的验证。目标1，验证蛋白质生物标志物能够区分癌前病变；目标 2，在一组注释良好的临床样本中验证蛋白质组生物标志物。研究 2 高甲基化标记的验证。目标1，验证基因甲基化以进行BBD风险分层；目标 2，针对 BBD 女性开发基于血清的检测方法。 EDRN 内外的众多合作者将利用 FCCC-EDRN-CVC 大量带注释的乳腺癌和卵巢良性和癌症血清、DNA 和组织样本集合。拟议的验证研究主要针对 BBD，并研究相同情况下的蛋白质和 DNA 甲基化。 FCCC EDRN-CVC 将帮助将生物标志物研究转化为社区实践。

DESCRIPTION (provided by applicant): The overall goals of the Early Detection Research Network (EDRN) are to: a) identify biomarkers for cancer risk, early detection, molecular diagnostics, and prognosis of early cancer; and b) coordinate biomarker research and therapeutic strategies in order to reduce cancer morbidity and mortality. As a Clinical Validation Center (CVC), Fox Chase Cancer Center (FCCC) will: 1) maintain the FCCC multidisciplinary team of biomarker validation investigators; 2) comply with terms and conditions of the EDRN cooperative agreement including data sharing; 3) partner with EDRN Biomarker Development Labs (BDLs), Biomarker Reference Labs (BRLs), CVCs, and the Data Management and Coordination Center (DMCC); 4) participate in EDRN Steering Committee and Scientific meetings and activities and the EDRN Breast/Ovarian Cancer Consortium Group; 5) collect, store and distribute tissue, sera, and DNA for biomarker discovery and validation research especially from women at risk for breast and ovarian cancer; 6) partner with Geisinger Medical Center to develop population-based biomarker research validation studies. FCCC-EDRN-CVC proposes an investigator-initiated proteomic and DNA methylation phase II biomarker validation research project in women with benign breast disease (BBD) who are at risk for invasive cancer. This research utilizes biosamples collected during the past five years of EDRN funding. The aims are as follows: Study 1, Validation of candidate proteomic biomarker in BBD. Aim 1, verify that protein biomarker can distinguish preca-ncer lesions; Aim 2, validate proteomic biomarker in a set of well annotated clinical specimens. Study 2 Validations of Hypermethylated Markers. Aim 1, verify gene methylation for risk stratification in BBD; Aim 2, develop a serum-based assay in women with BBD. Numerous collaborators in and outside EDRN will utilize the FCCC-EDRN-CVC large annotated collection of breast and ovarian benign and cancer sera, DNA, and tissue samples. The proposed validation study is focused on BBD and investigates protein and DNA methylation in the same cases. The FCCC EDRN-CVC will help to translate biomarker research to community practice.