Abstract
Background: A variety of molecular markers have been evaluated for the development of a non-invasive approach to the diagnosis of colorectal cancer. We aimed to validate the diagnostic accuracy, using the same threshold as in the previous pilot study, of fluorescent long DNA test as a relatively simple and inexpensive tool for colorectal cancer detection.Methods: A case-control study was conducted on 100 healthy subjects and 100 patients at first diagnosis of colorectal cancer. Human long-fragment DNA in stool was quantified by fluorescence primers and a standard curve and expressed in DNA nanograms.Results: We validated the 25-ng value, which emerged as the most accurate cut-off in the pilot study, obtaining 79% (95% CI, 71–87%) sensitivity and 89% (95% CI, 83–95%) specificity. Specificity was very high for all cut-off values (15–40 ng) analyzed, ranging from 78 to 96%. Sensitivity was only slightly lower, reaching 84% at the lowest cut-off and maintaining a good level at the higher values. Diagnostic potential was independent of gender, age and tumor site.Conclusion: Fecal DNA analysis is a non-invasive and fairly simple test showing high diagnostic potential. These characteristics, together with the small amount of stool required, make it potentially suitable to be used alongside or as an alternative to current non-invasive screening approaches. Our next step will be to validate these results in a large-scale cohort study of a screening population, which is needed prior to implementation into clinical practice.
Highlights
Colorectal cancer (CRC) is the third most common malignancy in the world [16]
fluorescence long DNA (FL-DNA) median values were independent of gender and age
Fecal DNA levels were independent of tumor size and site and slightly lower, albeit not significantly, in the few patients with Dukes’ stage D tumors compared to those with earlier stage tumors (Table 1)
Summary
Colorectal cancer (CRC) is the third most common malignancy in the world [16]. Screening for CRC has great potential to reduce morbidity and mortality from the disease, but currently only a small portion of eligible individuals undergo testing for early diagnosis [11]. A variety of genetic and epigenetic alterations, which commonly occur during evolution from normal colon mucosa to adenoma and carcinoma, such as K-ras, p53, APC gene mutations, microsatellite instability or epigenetic events, have been investigated [1,4,6,12,13,14,15, 19,20,21,22,24] The results from these studies have shown that individual molecular alterations are present in the stool of only a fraction of patients and are . We aimed to validate the diagnostic accuracy, using the same threshold as in the previous pilot study, of fluorescent long DNA test as a relatively simple and inexpensive tool for colorectal cancer detection
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