Serum Markers of Breast /Ovarian Cancer Risk

描述（由申请人提供）：乳腺癌和卵巢癌都是昂贵的 在发病率和死亡率方面。虽然这两种疾病都有一些 明确的行为风险因素，很少有，如果有的话，建立 风险的生物标志物。此外，具有以下特征的标记物很少： 在临床环境中应用的可能性，并且缺乏 前瞻性收集的数据和血清样本可供研究人员使用， 探索新的风险标记。在一个大的、前瞻性的环境中测试的这些标记物， 为了确定这些风险增加的妇女， 疾病，以及改善我们的风险评估模型， 有效的预防战略。我们建立了一个多机构的 与正在进行的多中心试验相关的联盟，以评估 前瞻性地将血清生物标志物作为乳腺癌的风险因素， 卵巢癌具体而言，我们将（1）。前瞻性地确定 雌激素代谢血清标志物、体重指数（BMI）和 激素替代疗法（HRT）对绝经后乳腺癌风险的影响;以及 （二）、前瞻性确定胰岛素相关血清的相关性 绝经后卵巢癌风险的生物标志物。为了实现我们的目标，我们 将在观察性研究中进行两项嵌套病例对照研究 (OS)女人的？健康倡议（WHI），一项多中心前瞻性研究 女人吗由美国国立卫生研究院资助。第一项研究将比较BMI、HRT和 在200例确诊的乳腺癌病例中，WHI库存血清中的雌激素代谢物水平 浸润性乳腺癌和200名健康女性的发病率， 研究中心。第二项研究将比较胰岛素、葡萄糖和胰岛素样 200例确诊病例中WHI库存血清中的生长因子水平 上皮性卵巢癌和200名健康女性的年龄，种族， 研究中心和HRT状态。风险因素、混杂因素和结局数据 已经由WHI临床协调中心收集和验证， 将以干净的研究数据库提供给我们。所有实验室检测均将 由经验丰富的合作研究人员执行，我们曾与他们合作 在过去。我们的研究的理由来自于我们掌握的初步数据， 生成的.已经获得了进行这种合作的批准 从WHI。在本项目结束时，我们将对 一些新的和有前途的乳腺癌和卵巢癌风险的血清标志物。我们 我还希望确定其他相关的研究问题，我们 预计在多中心，合作的方式进一步研究， WHI的各种武器。

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.