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.
The Clinical Validation Center will test new markers and approaches for the early detection of breast and gynecologic cancers. This is instrumental in developing strategies to target populations most at risk of disease for efficient detection and diagnosis. The work of this Center will also be critical for informing policy discussions and recommendations as we contemplate introduction of new screening modalities for these common and life threatening diseases.
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