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Cellular Oncology
Volume 31, Issue 1, Pages 11-17
http://dx.doi.org/10.3233/CLO-2009-0443

Quantitative Fluorescence Determination of Long-Fragment DNA in Stool as a Marker for the Early Detection of Colorectal Cancer

Daniele Calistri,1 Claudia Rengucci,1 Chiara Molinari,1 Enrico Ricci,2 Elena Cavargini,2 Emanuela Scarpi,1 Gian Luigi Milandri,3 Carla Fabbri,4 Alberto Ravaioli,4 Antonio Russo,5 Dino Amadori,1 and Rosella Silvestrini1

1Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, Italy
2Department of Gastroenterology, Morgagni-Pierantoni Hospital, Forlì, Italy
3Department of Gastroenterology, Bufalini Hospital, Cesena, Italy
4Department of Oncology, Infermi Hospital, Rimini, Italy
5Department of Surgery and Oncology, University of Palermo, Palermo, Italy

Copyright © 2009 Hindawi Publishing Corporation and the authors. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.