Abstract

We aimed to define the potential of the fecal DNA assay as an alternative or in addition to the currently used immunochemical fecal occult blood test (iFOBT) for the early diagnosis of colorectal cancer. A total of 560 individuals aged 50 to 69 years with a positive iFOBT were recruited from an Italian FOBT regional screening program. Twenty-six were diagnosed with adenocarcinoma, 264 with high-risk adenoma, and 54 with low-risk adenoma, whereas 216 subjects did not have premalignant or malignant lesions. Fecal DNA integrity was analyzed blindly by the fluorescence long DNA (FL-DNA) test. iFOBT and FL-DNA were largely independent variables (rs = 0.036, P = 0.42), with values ranging from 101 to 5,826 ng/mL and from 0 to 515 ng, respectively. Median values of both variables were significantly higher in cancer patients than in patients with noncancerous lesions or in healthy individuals. Moreover, iFOBT and FL-DNA values were individually associated with a number of pathologic parameters. Sequential use of the diagnostic iFOBT and FL-DNA methods showed that fecal DNA provided more accurate diagnostic information and was able to identify subgroups at different risk of cancer in iFOBT-positive individuals. A combined approach based on FL-DNA and iFOBT evaluation could help to better identify colorectal cancers and to determine a patient's risk of harboring a preneoplastic or neoplastic lesion. Further evaluation in a screening setting is needed to confirm this hypothesis. Fecal DNA could be a useful tool to better predict cancer risk in FOBT-positive individuals.

Highlights

  • The clinical outcome and quality of life of colorectal cancer patients have markedly improved over the last 20 years. This achievement is due partly to progress made in medical and surgical treatments, and to advances in the early noninvasive diagnosis of small tumors and preneoplastic lesions at high risk of malignant transformation. Like those of the breast and uterine cervix, are good targets for early diagnosis because they are often preceded by preneoplastic lesions that typically have a long natural history

  • A total of 560 fecal occult blood test (FOBT)-positive individuals were enrolled in the study, and all were submitted to endoscopic examination to confirm diagnosis; 26 were diagnosed with adenocarcinomas, 264 with high-risk adenomas, and 54 with low-risk adenomas

  • Patients were considered at high-risk when they had high-risk dysplasia, >3 adenomatous villous or tubulovillous polyps, at least one of which with a diameter of ≥1 cm, or an in situ carcinoma, whereas those who presented with

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Summary

Introduction

The clinical outcome and quality of life of colorectal cancer patients have markedly improved over the last 20 years. This achievement is due partly to progress made in medical and surgical treatments, and to advances in the early noninvasive diagnosis of small tumors and preneoplastic lesions at high risk of malignant transformation. The overall 5-year survival for colorectal cancer patients is around 64%, rising to almost 90% if tumors are diagnosed early [1, 2]. Authors' Affiliations: 1Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola and 2Cancer Prevention Unit, Morgagni-Pierantoni Hospital, Forlì, Italy. Corresponding Author: Daniele Calistri, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Via Piero Maroncelli 40, 47014 Meldola (FC), Italy. We aimed to define the potential of the fecal DNA assay as an alternative or in addition to the currently used immunochemical fecal occult blood test (iFOBT) for the early diagnosis of colorectal cancer

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