Improved Blood-Based Test for Breast Cancer

描述（由申请人提供）：乳腺癌是美国女性中最常见的癌症，是仅次于肺癌的第二大癌症相关死亡原因；2007年，确诊的乳腺癌新病例超过20万例，约有4万名妇女死亡。如果乳腺癌在诊断时没有扩散，那么乳腺癌的5年生存率约为95%；因此早期诊断至关重要。其中一个重要的挑战是基于血液的低成本乳腺癌检测，特别是对于非常年轻的女性，乳房x光检查是不可靠的。事实上，低成本的、基于血液的乳腺癌检测将大大提高所有年龄段女性BC检测的效率。与目前的成像模式相比，血液模式的成本降低了10到20倍，这将是一个强大的卖点。本课题的重点是增加队列的统计量，对我们的方法进行验证。我们期望达到98%的灵敏度和96%的特异性。公共卫生相关性：乳腺癌是美国妇女中最常见的癌症。如果乳腺癌在诊断时没有扩散，那么乳腺癌的5年生存率约为95%；因此早期诊断至关重要。重要的挑战是在年轻女性中发现乳腺癌，因为它们通常发生在相对年轻的年龄，很难通过乳房x光检查和核磁共振检查发现。但由于患病率较低，敏感性/特异性约为98%的方法有待开发。我们建议对已经达到95%敏感性/特异性的血液检测进行额外验证。

DESCRIPTION (provided by applicant): Breast cancer is the most common form of cancer among women in the United States and is second only to lung cancer as the cause of cancer-related death; in 2007, more than 200,000 new cases of breast cancer were diagnosed and approximately 40,000 women died. The five-year survival rate for breast cancer is about 95% if the cancer has not spread at the time of diagnosis; hence early diagnostics is vital. One of the important challenges is blood-based, low cost detection of breast cancers, especially for very young women wherein mammography is not reliable. Actually, availability of low cost, blood based breast cancer detection will drastically increase efficiency of detection of BC for women of all ages. Ten- to twenty-fold lower cost of blood-based modalities will be a strong selling point in comparison to current imaging modalities. This project focuses on increase of statistics of cohort on which the validation of our method was performed. We expect to reach the 98% sensitivity and 96% specificity. PUBLIC HEALTH RELEVANCE: Breast cancer is the most common form of cancer among women in the United States. The five-year survival rate for breast cancer is about 95% if the cancer has not spread at the time of diagnosis; hence early diagnostics is vital. Important challenge is detection of breast cancers in younger women, because they often occur at a relatively young age and are difficult to detect by both mammography and MRI. However, because of relatively low prevalence, the method with sensitivity/specificity of about 98% needs to be developed. We propose the additional validation of our blood-based tests, which already achieved the 95% sensitivity/specificity.