clinical validation results of an innovative non-invasive device for colorectal cancer preventive screening through fecal exhalation analysis

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ID: 143731
2020
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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).
Reference Key
zonta2020cancersclinical Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors ;Giulia Zonta;Cesare Malagù;Sandro Gherardi;Alessio Giberti;Alessandro Pezzoli;Aldo De Togni;Caterina Palmonari
Journal The Journal of investigative dermatology
Year 2020
DOI
10.3390/cancers12061471
URL
https://www.mdpi.com/2072-6694/12/6/1471
Keywords
colorectal cancer sensors crc Oncology clinical validation including cancer and carcinogens tumors

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