Atlantic Breast and Gynecologic Clinical Validation Center

描述（由申请人提供）：我们建议在早期检测研究网络内建立一个临床验证中心，专注于乳腺癌和妇科癌症。我们的团队拥有无与伦比的丰富经验和临床资源。该中心将由两个主要站点组成：杜克大学医学中心（DUMC）和约翰霍普金斯医学研究所（JHMI）。每个站点都将提供包括标本和数据在内的临床资源，并将在生物标志物验证试验上进行协作和协调。我们小组的主要任务是比较有前途的生物标志物在乳腺癌、卵巢癌和宫颈癌的特定临床应用中的效用。我们建议这将包括总体风险、早期发现、疾病进展可能性和疾病监测的研究。我们并不期望对所有疾病都进行这样的研究；然而，我们准备在项目开始时进行几项这样的研究。这些研究包括宫颈发育不良的高危病变标志物，浸润前乳腺癌的进展标志物，浆液性卵巢癌的预后预测因子。为实现这些目标，我们将使用的资源包括：1)高且一致的患者数量和受试者招募，2)大量且成熟的临床标本，包括血清、血浆、DNA和组织，所有这些标本都相互关联并定期更新，3)大量标本已经用分子数据进行了注释，包括基因表达、CGH、SNP、甲基化和蛋白质组学分析，4)卵巢癌的大型基于人群的病例对照研究，5)访问其他大型数据和临床资源，包括卵巢癌协会联盟和来自癌症基因组图谱（TCGA）的乳腺癌和卵巢癌的第一贡献者信息。我们的专业知识来自于这些疾病的生物标志物的发现和开发，并通过各种严格的人口科学，统计学和临床研究来增强。本中心还将充分参与网络的所有活动，并根据需要在网络内外寻求更多合作，以推进工作。

DESCRIPTION (provided by applicant): We propose to create a Clinical Validation Center within the Early Detection Research Network that is focused on breast and gynecologic cancers. Our group brings a combination of depth of experience and clinical resources that would be difficult to match. This Center will be comprised of two primary sites: Duke University Medical Center (DUMC) and Johns Hopkins Medical Institute (JHMI). Each of these sites will contribute clinical resources including specimens and data and will collaborate and coordinate on biomarker validation trials. The primary mission of our group will be to compare promising biomarkers for their utility in specific clinical applications for breast, ovarian, and cervical cancer. We propose that this will include studies of overall risk, early detection, likelihood of disease progression, and disease monitoring. We not expect that all such studies will be performed for all diseases; however we are prepared to perform several such studies at the onset of the program. These studies include markers of high risk lesions in cervical dysplasia, markers of progression in pre-invasive breast cancer, and predictors of outcome in serous ovarian cancer. The resources that we will use to accomplish these goals include: 1) High and consistent patient volume and subject recruitment, 2) Large and mature collections of clinical specimens including serum, plasma, DNA, and tissue all linked and updated regularly, 3) Large subsets of specimens are already annotated with molecular data including gene expression, CGH, SNP, methylation, and proteomic analyses, 4) A large population based case control study in ovarian cancer, 5) Access to other large data and clinical resources including the Ovarian Cancer Association Consortium and first contributor information from The Cancer Genome Atlas (TCGA) for both breast and ovarian cancer. Our expertise comes from biomarker discovery and development in these diseases and is augmented by the various rigors of population science, statistics, and clinical research. Our Center will also participate fully in all activities of the Network and seek additional collaborations within and outside the Network as needed to advance the work.