Mammography is the predominant screening method for early detection of breast cancer, but has limitations and could be rendered more accurate by combination with a blood-based biomarker profile. Circulating microRNAs (miRNAs) are increasingly recognized as strong biomarkers, and we previously developed a 9-miRNA profile using serum and LNA-based qPCR that effectively stratified patients with early stage breast cancer vs. healthy women. To further develop the test into routine clinical practice, we collected serum of women examined by clinical mammography (N = 197) according to standard operational procedures (SOPs) of the Danish Cancer Biobank. The performance of the circulating 9-miRNA profile was analyzed in 116 of these women, including 36 with breast cancer (aged 50–74), following a standardized protocol that mimicked a routine clinical set-up. We confirmed that the profile is significantly different between women with breast cancer and controls (p-value <0.0001), with an AUC of 0.61. Significantly, one woman whose 9-miRNA profile predicted a 73% probability of having breast cancer indeed developed the disease within one year despite being categorized as clinically healthy at the time of blood sample collection and mammography. We propose that this miRNA profile combined with mammography will increase the overall accuracy of early detection of breast cancer.

乳腺钼靶造影是早期发现乳腺癌的主要筛查方法，但存在局限性，可以与基于血液的生物标志物谱结合使用，从而变得更加准确。循环微RNA（miRNA）日益被认为是强大的生物标志物，我们之前使用基于血清和LNA的qPCR开发了9-miRNA谱，可有效地将早期乳腺癌患者与健康女性进行分层。为了将测试进一步发展为常规临床实践，我们根据丹麦癌症生物库的标准操作程序（SOP）收集了接受临床X线摄影（N = 197）检查的女性血清。按照模仿常规临床设置的标准化方案，对116名女性（包括36名乳腺癌患者（年龄在50-74岁之间））中的循环9-miRNA谱进行了分析。我们证实，乳腺癌女性和对照女性之间的特征存在显着差异（p值<0.0001），AUC为0.61。值得注意的是，尽管在血液样本采集和乳房X线摄影时被归类为临床健康人群，但其9-miRNA谱预测有73％的可能性在一年内确实罹患了乳腺癌。我们建议将这种miRNA谱图与乳腺摄影相结合，可以提高乳腺癌早期检测的总体准确性。一名妇女的9-miRNA谱预测在患乳腺癌的概率为73％，尽管在血液样本采集和X线摄影时被归类为临床上健康，但在一年内确实会罹患该疾病。我们建议将这种miRNA谱图与乳腺摄影相结合，可以提高乳腺癌早期检测的总体准确性。一名妇女的9-miRNA谱预测在患乳腺癌的概率为73％，尽管在血液样本采集和X线摄影时被归类为临床上健康，但在一年内确实会罹患该疾病。我们建议将这种miRNA谱图与乳腺摄影相结合，可以提高乳腺癌早期检测的总体准确性。