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

 描述(申请人提供)：临床问题：乳腺癌是女性最常见的癌症，是仅次于肺癌的癌症死亡原因。乳房X光检查是筛查乳腺癌的主要手段，但其价值因其大量的假阳性和假阴性结果而受到限制。一种解决问题的新方法：两种具有不同生物机制的诊断测试相结合，可能比单独使用任何一种测试都更敏感和特异。针对乳腺癌生物标志物的呼气测试可能会提高乳房X光检查的敏感性和特异度，并显著减少乳房X光检查产生的假阳性和假阴性测试结果的数量。研究目标：我们将检验这样一种假设，即呼吸链接呼吸测试与乳房X光检查相结合，将导致假阳性和假阴性测试结果明显少于单独使用乳房X光检查。我们将通过在五个地点对2000名女性进行BreathLink呼气测试来实现这一目标，这些女性正在接受乳房相关症状或体征(例如乳房肿块)的乳房X光检查。这项研究的预期结果：我们预计，BreathLink呼气测试与乳房X光检查相结合将大大减少仅由乳房X光检查产生的假阳性和假阴性测试结果的数量。这项研究可能会为检测患有乳腺癌的女性建立一个新的范式。将本质安全的呼气测试与乳房X光检查相结合，可能会减少现在进行的不必要的乳房X光检查和乳房活组织检查的数量，同时相应地减少辐射暴露、不适、活组织检查的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.