Universities of Giessen and Marburg Lung Center (UGMLC), Member of the German Center for Lung Research (DZL), Klinikstr. 33, 35392 Giessen, Germany. European IPF Registry & Biobank (eurIPFreg), 35392 Giessen, Germany.
J Breath Res. 2020 Jul 24;14(4):046004. doi: 10.1088/1752-7163/ab8c50.
There is a high unmet need in a non-invasive screening of lung cancer (LC). We conducted this single-center trial to evaluate the effectiveness of the electronic nose Aeonose in LC recognition.
Exhaled volatile organic compound (VOC) signatures were collected by Aeonose in 42 incident and 78 prevalent LC patients, of them 29 LC patients in complete remission (LC CR), 33 healthy controls (HC) and 23 COPD patients. By dichotomous comparison of VOC's between incident LC and HC, a discriminating algorithm was established and also applied to LC CR and COPD subjects. Area under Curve (AUC), sensitivity, specificity and Matthews's correlation coefficient (MC) were used to interpret the data.
The established algorithm of Aeonose signature allowed safe separation of LC and HC, showing an AUC of 0.92, sensitivity of 0.84 and a specificity of 0.97. When tested in a blinded fashion, the device recognized 19 out of 29 LC CR patients (=65.5%) as LC-positive, of which only five developed recurrent LC later on (after 18.6 months [Formula: see text]; mean value [Formula: see text]). Unfortunately, the algorithm also recognized 11 of 24 COPD patients as being LC positive (with only one of the 24 COPD patients developing LC 56 months after the measurement).
The Aeonose revealed some potential in distinguishing LC from HC, however, with low specificity when applying the algorithm in a blinded fashion to other disease cohorts. We conclude that relevant VOC signals originating from comorbidities in LC such as COPD may have erroneously led to the separation between LC and controls.
(NCT02951416).
肺癌(LC)的无创筛查存在巨大的未满足需求。我们进行了这项单中心试验,以评估电子鼻 Aeonose 在 LC 识别中的有效性。
通过 Aeonose 收集 42 例新发和 78 例现患 LC 患者、29 例完全缓解的 LC 患者(LC CR)、33 例健康对照者(HC)和 23 例 COPD 患者的呼气挥发性有机化合物(VOC)特征。通过对新发 LC 和 HC 之间 VOC 的二分类比较,建立了一个判别算法,并将其应用于 LC CR 和 COPD 患者。曲线下面积(AUC)、敏感性、特异性和马修斯相关系数(MC)用于解释数据。
Aeonose 特征的建立算法可以安全地区分 LC 和 HC,AUC 为 0.92,敏感性为 0.84,特异性为 0.97。在盲法测试中,该设备识别出 29 例 LC CR 患者中的 19 例(65.5%)为 LC 阳性,其中仅 5 例后来(18.6 个月后[公式:见正文])复发 LC。不幸的是,该算法还识别出 24 例 COPD 患者中的 11 例为 LC 阳性(24 例 COPD 患者中只有 1 例在测量后 56 个月发生 LC)。
Aeonose 在区分 LC 和 HC 方面显示出一定的潜力,但在将算法应用于其他疾病队列的盲法时特异性较低。我们得出结论,来自 LC 合并症(如 COPD)的相关 VOC 信号可能错误地导致了 LC 与对照者的分离。
(NCT02951416)。