Serum Markers of Breast /Ovarian Cancer Risk

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DESCRIPTION (provided by applicant): Both breast and ovarian cancers are costly in terms of morbidity and mortality to women. While both diseases have some well-defined behavioral risk factors, there are few, if any, established biomarkers of risk. Moreover, there are a paucity of markers that have the possibility to be applied in a clinical setting, and there is a lack of prospectively collected data and serum samples available to researchers to explore new risk markers. Such markers, tested in a large, prospective setting, are urgently needed in order to identify women at an increased risk for these diseases, as well as to improve our models of risk assessment and to devise effective prevention strategies. We have formed a multi-institutional consortium linked to an ongoing multi-center trial in order to evaluate prospectively the utility of serum biomarkers as risk factors for breast and ovarian cancers. In particular, we will (1). determine prospectively the effects of serum markers of estrogen metabolism, body mass index (BMI), and hormone replacement therapy (HRT) on postmenopausal breast cancer risk; and (2). determine prospectively the association of insulin related serum biomarkers on postmenopausal ovarian cancer risk. To achieve our objectives, we will undertake two nested case-control studies within the Observational Study (OS) of the Women?s Health Initiative (WHI), a multi-center prospective study of women?s health funded by the NIH. The first study will compare BMI, HRT and estrogen metabolite levels in WHI banked serum between 200 confirmed cases of invasive breast cancer and 200 healthy women frequency matched by age, race and study site. The second study will compare insulin, glucose and insulin-like growth factor levels in WHI banked serum between 200 confirmed cases of epithelial ovarian cancer and 200 healthy women frequency matched by age, race, study site and HRT status. Risk factor, confounding and outcomes data has already been collected and verified by the WHI Clinical Coordinating Center and will be provided to us in a clean study database. All laboratory assays will be performed by experienced, collaborating investigators with whom we have worked in the past. Justification for our studies comes from preliminary data we have generated. Approval to undertake this collaboration has already been obtained from the WHI. By the end of this project, we will have prospectively evaluated some new and promising serum markers of risk for breast and ovarian cancer. We also expect to identify additional related research questions, which we anticipate studying further in a multi-center, collaborative fashion within the various arms of the WHI.