Improved Blood-Based Test for Breast Cancer

描述(申请人提供)：乳腺癌是美国女性中最常见的癌症，是仅次于肺癌的与癌症相关的死亡原因；2007年，超过20万例新的乳腺癌病例被诊断出来，大约40,000名女性死亡。如果诊断时乳腺癌没有扩散，乳腺癌的五年存活率约为95%；因此，早期诊断至关重要。一个重要的挑战是基于血液的低成本乳腺癌检测，特别是对于乳房X光检查不可靠的非常年轻的女性。事实上，低成本、基于血液的乳腺癌检测将极大地提高各个年龄段女性的BC检测效率。与目前的成像方式相比，基于血液的方式的成本降低了10到20倍，这将是一个强有力的卖点。本项目的重点是增加队列的统计量，在此基础上对我们的方法进行验证。我们期望达到98%的敏感性和96%的特异性。公共卫生相关性：乳腺癌是美国女性中最常见的癌症形式。如果诊断时乳腺癌没有扩散，乳腺癌的五年存活率约为95%；因此，早期诊断至关重要。重要的挑战是在年轻女性中检测乳腺癌，因为它们通常发生在相对年轻的年龄，而且很难通过乳房X光照相和核磁共振检测出来。然而，由于发病率相对较低，需要开发灵敏度/特异度约为98%的方法。我们建议对我们的血液检测进行额外的验证，它已经达到了95%的敏感度/特异度。

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.