Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis
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 colon...
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| Format: | Article |
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MDPI AG
2020-06-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/12/6/1471 |
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| author | Giulia Zonta Cesare Malagù Sandro Gherardi Alessio Giberti Alessandro Pezzoli Aldo De Togni Caterina Palmonari |
| author_facet | Giulia Zonta Cesare Malagù Sandro Gherardi Alessio Giberti Alessandro Pezzoli Aldo De Togni Caterina Palmonari |
| author_sort | Giulia Zonta |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-03-10T19:21:30Z |
| format | Article |
| id | doaj.art-15057fcc43b143d68ca4b681c027bf3c |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-10T19:21:30Z |
| publishDate | 2020-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-15057fcc43b143d68ca4b681c027bf3c2023-11-20T02:53:12ZengMDPI AGCancers2072-66942020-06-01126147110.3390/cancers12061471Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation AnalysisGiulia Zonta0Cesare Malagù1Sandro Gherardi2Alessio Giberti3Alessandro Pezzoli4Aldo De Togni5Caterina Palmonari6Department of Physics and Earth Sciences, University of Ferrara, Via Savonarola, 9-44121 Ferrara, ItalyDepartment of Physics and Earth Sciences, University of Ferrara, Via Savonarola, 9-44121 Ferrara, ItalySCENT (Semiconductor-Based Electronic Network for Tumors) S.r.l., Via Quadrifoglio 11, 44124 Ferrara, ItalyMIST E-R s.c.r.l. (MISTER Smart Innovation), Via P. Gobetti 101, 40129 Bologna, ItalySt. Anna Hospital, Via Aldo Moro, 44124 Ferrara, ItalyDepartment of Public Health (AUSL)—UO Igiene Pubblica—Via Fausto Beretta, 7-44121 Ferrara, ItalyDepartment of Physics and Earth Sciences, University of Ferrara, Via Savonarola, 9-44121 Ferrara, ItalyScreening 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).https://www.mdpi.com/2072-6694/12/6/1471CRCcolorectal cancersensorspreventive screeningclinical validationbiomarkers |
| spellingShingle | Giulia Zonta Cesare Malagù Sandro Gherardi Alessio Giberti Alessandro Pezzoli Aldo De Togni Caterina Palmonari Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis Cancers CRC colorectal cancer sensors preventive screening clinical validation biomarkers |
| title | Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis |
| title_full | Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis |
| title_fullStr | Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis |
| title_full_unstemmed | Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis |
| title_short | Clinical Validation Results of an Innovative Non-Invasive Device for Colorectal Cancer Preventive Screening through Fecal Exhalation Analysis |
| title_sort | clinical validation results of an innovative non invasive device for colorectal cancer preventive screening through fecal exhalation analysis |
| topic | CRC colorectal cancer sensors preventive screening clinical validation biomarkers |
| url | https://www.mdpi.com/2072-6694/12/6/1471 |
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