Abstract
11062 Background: A promising approach for the early diagnosis of colorectal cancer (CRC) is the evaluation of genomic DNA integrity (FL-DNA) extracted from stool. Pilot and confirmatory studies carried out by our group have shown that, thanks to its diagnostic accuracy, this molecular assay could be a useful tool for the non-invasive, early diagnosis of CRC. The aim of the present study was to verify whether the FL-DNA method could represent a valid alternative to the fecal occult blood test (FOBT) or whether it could be used alongside FOBT in screening programs to unmask false FOBT positives and spare patients from unnecessary colonoscopy. For this purpose, stool samples were collected from all individuals participating in the FOBT (OC-Sensor, Alpha Wassermann) Regional Screening Program run by the Cancer Prevention Unit of Morgagni-Pierantoni Hospital in Forli. Methods: The program recruited subjects of either sex aged 50 to 69 years. Of the 560 individuals with FOBT-positive stool subjected to colonoscopy, 26 were diagnosed with adenocarcinoma, 264 with high-grade adenoma and 54 with low-grade adenoma. More than one third (216) of the group had only benign disease (hemorrhoids, diverticulitis, inflammation, etc), hyperplastic polyps or nothing. The integrity of fecal DNA was analyzed blindly by the FL-DNA test on the same specimen used for the occult blood determination. Results: Using a cut-off of 10 ng, the molecular analysis detected over 90% of the colorectal cancers and about 50% of the high- and low-grade adenomas. In particular, diagnostic accuracy was similar for lesions of any localization, level of dysplasia and histopathological characteristic, and higher for lesions > 2 cm and multiple lesions. The test also confirmed its capacity to identify colorectal cancer in asymptomatic individuals. Conclusions: FL-DNA represents a valid alternative to or support for approaches currently used in screening programs. A more in depth DNA stool evaluation in negative FOBT individuals could reveal the test's usefulness in unmasking colorectal tumors and adenomas missed by FOBT. No significant financial relationships to disclose.
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