Atlantic Breast and Gynecologic Clinical Validation Center

描述(由申请人提供)：我们建议在早期发现研究网络内创建一个临床验证中心，专注于乳腺癌和妇科癌症。我们的团队带来了难以匹敌的深度经验和临床资源的结合。该中心将由两个主要地点组成：杜克大学医学中心(DUMC)和约翰霍普金斯大学医学研究所(JHMI)。这些网站中的每一个都将提供包括标本和数据在内的临床资源，并将在生物标记物验证试验方面进行合作和协调。我们小组的主要任务将是比较有前景的生物标记物在乳腺癌、卵巢癌和宫颈癌的特定临床应用中的实用性。我们建议，这将包括对总体风险、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进行所有这类研究；然而，我们准备在项目开始时进行几项这样的研究。这些研究包括宫颈异型增生高危病变的标记物，浸润性前乳腺癌进展的标记物，以及浆液性卵巢癌的预后预测因素。我们的专业知识来自这些疾病的生物标记物的发现和开发，并通过人口科学、统计学和临床研究的各种严格要求而得到加强。本中心还将全面参与网络的所有活动，并在需要时寻求网络内外的更多合作，以推动工作。

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.