Mammaglobin as a Marker for Breast Cancer Detection

描述(申请人提供)：乳房球蛋白是一种乳房特有的基因，已显示出作为乳腺癌特定检测的新标记物的前景。有几个重要的特征使乳头球蛋白成为检测乳腺癌的理想候选标记物。首先，它是一种乳房特有的基因，因此在乳房外检测到乳房巨球蛋白就表明患有乳腺癌。其次，在原发乳腺癌中，乳房巨球蛋白阳性的比例很高(超过80%)，在转移性乳腺癌中也有同样高的表达模式，这使得乳房巨球蛋白成为乳腺癌检测的一个有希望的候选标记基因。第三，乳巨球蛋白是一种低分子的分泌性蛋白质，初步数据表明，它存在于一些乳腺癌患者的血清中。因此，乳巨球蛋白有可能作为乳腺癌检测的血清标志物。这项研究的近期目标是： 1)采用酶联免疫吸附试验检测血清中的乳铁蛋白，评估并建立正常女性的乳铁蛋白水平。这一目标将有助于建立绝经前和绝经后妇女、孕妇的基线值，并探索可能改变乳巨球蛋白水平的因素。 2)应用酶联免疫吸附试验检测乳腺癌患者的乳房巨球蛋白水平，并通过免疫组织化学方法检测乳房巨球蛋白与原发肿瘤的相关性。循环中乳腺肿瘤细胞的存在将通过对这些样本中的黄褐色大衣进行特定的RT/PCR分析来检查。 3)通过酶联免疫吸附试验和/或逆转录聚合酶链式反应来检验血液中乳铁蛋白的表达将预测乳腺癌患者的治疗反应和复发的假设。 这项提案的范围是解决是否可以在乳腺癌女性患者的血清中检测到乳头球蛋白，并确定与正常对照组相比，血清中检测到的乳球蛋白与乳腺癌是否存在相关性。

DESCRIPTION (provided by applicant): Mammaglobin is a breast-specific gene that has shown promise as a new marker for the specific detection of breast cancer. There are several important features that make mammaglobin an ideal candidate as a marker for breast cancer detection. One, it is a breast-specific gene, therefore mammaglobin's detection outside the breast indicates breast cancer disease. Secondly, the high percentage of primary breast cancers that are mammaglobin positive (more than 80%), and an equally high percentage expression pattern in metastatic breast cancer, make mammaglobin a promising candidate marker gene for breast cancer detection. Thirdly, mammaglobin is a secreted protein of low molecular weight, and preliminary data indicate its presence in the sera of some breast cancer patients. Therefore, mammaglobin may have utility as a serum marker for breast cancer detection. The immediate goals of this study will be to: 1) Using the ELISA assay for the serum detection of mammaglobin, we will evaluate and establish mammaglobin levels in normal women. This aim will help establish baseline values in both pre- and postmenopausal women, pregnant women, and explore factors that may modify mammaglobin levels. 2) Using the ELISA assay, we will evaluate the levels of mammaglobin in breast cancer patients and correlate this data to the primary tumor using immunohistochemical examination for mammaglobin. The presence of circulating breast tumor cells will be examined using a specific RT/PCR analysis of buffy coats from these samples. 3) Test the hypothesis that mammaglobin expression in blood by ELISA and/or RT-PCR will predict response to therapy and predict relapse in patients with mammaglobin expressing breast tumors. The scope of this proposal is to address whether mammaglobin protein can be detected in the serum of women with breast cancer and determine if serum detection of mammaglobin has any correlation to breast cancer when compared to normal control groups.