Serum Markers of Breast /Ovarian Cancer Risk

描述(申请人提供)：乳腺癌和卵巢癌的成本都很高 在妇女发病率和死亡率方面。虽然这两种疾病都有一些 明确定义的行为风险因素，即使有，也很少。 风险的生物标志物。此外，很少有标记物具有 在临床环境中应用的可能性，但缺乏 预期收集的数据和血清样本，供研究人员使用 探索新的风险标记物。这样的标记，在一个大型的，预期的环境中进行了测试， 是迫切需要的，以便确定患这些疾病的风险增加的妇女 以及改进我们的风险评估模型和设计 有效的预防策略。我们已经形成了一个多机构的 与正在进行的多中心试验相关联的财团，以评估 血清生物标记物作为乳腺癌和乳腺癌危险因素的应用 卵巢癌。特别是，我们将(1)。前瞻性地确定 雌激素代谢的血清标志物、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 (2)。前瞻性地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。为了达到我们的目标，我们 将在观察性研究中进行两项嵌套病例对照研究 (OS)妇女？S健康倡议，一项多中心前瞻性研究 女性？S健康由美国国立卫生研究院资助。第一项研究将比较BMI、HRT和 200例确诊患者WHI库血清中雌激素代谢物水平 浸润性乳腺癌和200名健康女性按年龄、种族和性别匹配的频率 学习地点。第二项研究将比较胰岛素、葡萄糖和类胰岛素 200例确诊病例WHI库血清中生长因子水平 上皮性卵巢癌和200名健康女性的频率按年龄、种族、 研究地点和HRT状态。风险因素、混淆和结果数据具有 已由WHI临床协调中心收集和验证，并 将在一个干净的研究数据库中提供给我们。所有的实验室化验都将是 由与我们合作过的经验丰富、合作的调查人员执行 在过去。我们研究的理由来自于我们拥有的初步数据 已生成。已获得开展此合作的批准 从WHI来的。到这个项目结束时，我们将有前瞻性的评估 一些新的和有希望的乳腺癌和卵巢癌风险的血清标志物。我们 还希望确定更多相关的研究问题，我们 预计将以多中心、协作的方式在 WHI的不同分支。

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.