Next Article in Journal
The Expression, Functions and Mechanisms of Circular RNAs in Gynecological Cancers
Previous Article in Journal
Prognostic Value of Peripheral Blood Lymphocyte Telomere Length in Gynecologic Malignant Tumors
Article

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

1
Department of Physics and Earth Sciences, University of Ferrara, Via Savonarola, 9-44121 Ferrara, Italy
2
SCENT (Semiconductor-Based Electronic Network for Tumors) S.r.l., Via Quadrifoglio 11, 44124 Ferrara, Italy
3
MIST E-R s.c.r.l. (MISTER Smart Innovation), Via P. Gobetti 101, 40129 Bologna, Italy
4
St. Anna Hospital, Via Aldo Moro, 44124 Ferrara, Italy
5
Department of Public Health (AUSL)—UO Igiene Pubblica—Via Fausto Beretta, 7-44121 Ferrara, Italy
*
Author to whom correspondence should be addressed.
Cancers 2020, 12(6), 1471; https://doi.org/10.3390/cancers12061471
Received: 30 April 2020 / Revised: 28 May 2020 / Accepted: 2 June 2020 / Published: 4 June 2020
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). View Full-Text
Keywords: CRC; colorectal cancer; sensors; preventive screening; clinical validation; biomarkers CRC; colorectal cancer; sensors; preventive screening; clinical validation; biomarkers
Show Figures

Figure 1

MDPI and ACS Style

Zonta, G.; Malagù, C.; Gherardi, S.; Giberti, A.; Pezzoli, A.; De Togni, A.; Palmonari, C. Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis. Cancers 2020, 12, 1471. https://doi.org/10.3390/cancers12061471

AMA Style

Zonta G, Malagù C, Gherardi S, Giberti A, Pezzoli A, De Togni A, Palmonari C. Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis. Cancers. 2020; 12(6):1471. https://doi.org/10.3390/cancers12061471

Chicago/Turabian Style

Zonta, Giulia, Cesare Malagù, Sandro Gherardi, Alessio Giberti, Alessandro Pezzoli, Aldo De Togni, and Caterina Palmonari. 2020. "Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis" Cancers 12, no. 6: 1471. https://doi.org/10.3390/cancers12061471

Find Other Styles
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Back to TopTop