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. 2020 Jun 4;12(6):1471.
doi: 10.3390/cancers12061471.

Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis

Giulia Zonta  1   2 , Cesare Malagù  1   2 , Sandro Gherardi  2 , Alessio Giberti  3 , Alessandro Pezzoli  4 , Aldo De Togni  5 , Caterina Palmonari  1   5
Affiliations

Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis

Giulia Zonta et al. Cancers (Basel). .

Abstract

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).

Keywords: CRC; biomarkers; clinical validation; colorectal cancer; preventive screening; sensors.

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Conflict of interest statement

The authors declare that there is no conflict of interest regarding the publication of this article.

Figures

Figure 1
Figure 1
Device SCENT A1. External view.
Figure 2
Figure 2
Nanostructured gas sensor bonded with gold wires to its support and scheme of its structure.
Figure 3
Figure 3
Dynamical response curves of the sensor array employed for the analysis on two positive FIT subjects. On the left graph the subject resulted negative to colonoscopy, on the right graph the subject was CRC affected.
Figure 4
Figure 4
Flow-chart of the study.
Figure 5
Figure 5
Sensitivity and specificity distributions. The mean values obtained are 84.1% and 82.4%, respectively.
Figure 6
Figure 6
All the data (on 398 FOBT positives) with the two types of division into categories depending on colonoscopy outcomes. (A) Division into three categories of risk: NEG (negative to colonoscopy), LOW (low risk adenomas) and CRC+HR (carcinomas and high-risk adenomas); (B) division into two categories: NEG and POS (CRC + HR + LOW).
Figure 7
Figure 7
Graphic that represents total data classifications: negatives (TN and FP, empty dots) and positives (TP and FN, filled dots).
See this image and copyright information in PMC

References

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