Validation of a rapid point-of-care breath test for breast cancer

 描述（由申请人提供）：临床问题：乳腺癌是女性中最常见的癌症，作为癌症死亡原因仅次于肺癌。乳房X线摄影是筛查乳腺癌的主要手段，尽管其价值受到大量假阳性和假阴性结果的限制。一个新的解决方案的问题：具有不同生物学机制的两种诊断测试的组合可以比单独使用的任何一种测试更敏感和特异。乳腺癌生物标志物的BreathLInk呼吸测试可能会增加乳腺X射线摄影的灵敏度和特异性，并显着减少乳腺X射线摄影产生的假阳性和假阴性测试结果的数量。研究目的：我们将检验以下假设：与单独使用乳房X线摄影相比，BreathLink呼吸测试与乳房X线摄影联合使用将导致显著更少的假阳性和假阴性测试结果。我们将通过在5个研究中心的2，000名女性中进行BreathLink呼吸测试来实现这一目标，这些女性因乳房相关症状或体征（例如乳房肿块）而接受乳房X光检查。研究的预期结果：我们预计，BreathLink呼吸测试结合乳房X线摄影将显着减少由乳房X线摄影单独产生的假阳性和假阴性测试结果的数量。这项研究可能为检测乳腺癌妇女建立一个新的范例。将本质安全的呼吸测试与乳房X线摄影相结合，可以潜在地减少现在进行的不必要的乳房X线摄影和乳房活检的数量，从而相应地减少辐射暴露、不适、活检并发症和医疗保健系统的成本。

 DESCRIPTION (provided by applicant): The clinical problem: Breast cancer is the commonest cancer in women, in whom it is second only to lung cancer as a cause of cancer death. Mammography is the mainstay of screening for breast cancer, though its value is limited by its large number of false-positive and false-negative findings. A new solution the problem: The combination of two diagnostic tests with different biological mechanisms can be more sensitive and specific than either test employed alone. The BreathLInk breath test for biomarkers of breast cancer could potentially increase the sensitivity and specificity of mammography, and significantly reduce the number of false-positive and false-negative test results arising from mammography. Goal of the research: We will test the hypothesis that the BreathLink breath test combined with mammography will result in significantly fewer false-positive and false-negative test results than with mammography alone. We will achieve this goal by performing BreathLink breath tests in 2,000 women at five sites who are having mammography for breast-related symptoms or signs (e.g. breast mass). Expected outcomes of the research: We expect that that the BreathLink breath test combined with mammography will significantly reduce the number of false-positive and false-negative test results arising from mammography alone. This research could establish a new paradigm for detecting women with breast cancer. The combination of an intrinsically safe breath test with mammography could potentially reduce the number of needless mammograms and breast biopsies that are now performed, with a commensurate reduction in radiation exposure, discomfort, complications of biopsies, and costs to the health care system.