Zonta Giulia, Malagù Cesare, Gherardi Sandro, Giberti Alessio, Pezzoli Alessandro, Togni Aldo De, Palmonari Caterina
Department of Physics and Earth Sciences, University of Ferrara, Via Savonarola, 9-44121 Ferrara, Italy.
SCENT (Semiconductor-based electronic network for tumors) S.r.l., Via Quadrifoglio 11, 44124 Ferrara, Italy.
Cancers (Basel). 2020 Jun 4;12(6):1471. doi: 10.3390/cancers12061471.
Screening is recommended to reduce both incidence and mortality of colorectal cancer. Currently, many countries employ fecal occult blood test (FOBT). In Emilia-Romagna (Italy), since 2005, FOBT immunochemical version (FIT) is performed every two years on people aged between 50 and 69 years. A colonoscopy is then carried out on those who are FIT positive. However, FIT shows approximately 65% false positives (non-tumoral bleedings), leading to many negative colonoscopies. The use of an economic and easy-to-use method to check FOBT-positives will improve screening effectiveness, reducing costs to the national health service. This work illustrates the results of a three-year clinical validation protocol (started in 2016) of a patented device composed of a core of nanostructured gas sensors. This device was designed to identify CRC presence by fecal volatile compounds, with a non-invasive, in vitro and low-cost analysis. Feces are, in fact, affected by tumor-volatile biomarkers, produced by cellular peroxidation and metabolic alterations. The protocol consisted in the analysis of fecal samples of FIT-positive subjects, using colonoscopy as a gold standard. A total of 398 samples were analyzed with machine learning techniques, leading to a sensitivity and specificity of 84.1% and 82.4%, respectively, and a positive predictive value of 72% (25-35% for FIT).
建议进行筛查以降低结直肠癌的发病率和死亡率。目前，许多国家采用粪便潜血试验（FOBT）。在意大利的艾米利亚 - 罗马涅，自2005年以来，每两年对50至69岁的人群进行免疫化学法粪便潜血试验（FIT）。然后对FIT呈阳性的人进行结肠镜检查。然而，FIT显示出约65%的假阳性（非肿瘤性出血），导致许多结肠镜检查结果为阴性。使用一种经济且易于使用的方法来检查FIT阳性者将提高筛查效率，降低国家医疗服务的成本。这项工作阐述了一项为期三年的临床验证方案（于2016年开始）的结果，该方案针对一种由纳米结构气体传感器核心组成的专利设备。该设备旨在通过粪便挥发性化合物来识别结直肠癌的存在，采用非侵入性、体外且低成本的分析方法。事实上，粪便会受到细胞过氧化和代谢改变产生的肿瘤挥发性生物标志物的影响。该方案包括以结肠镜检查作为金标准，对FIT阳性受试者的粪便样本进行分析。共使用机器学习技术分析了398个样本，灵敏度和特异度分别为84.1%和82.4%，阳性预测值为72%（FIT为25 - 35%）。
