Three-Year Interval for the Multi-Target Stool DNA Test for Colorectal Cancer Screening: A Longitudinal Study

dc.contributor.authorImperiale, Thomas F.
dc.contributor.authorLavin, Philip T.
dc.contributor.authorMarti, Tara N.
dc.contributor.authorJakubowski, Debbie
dc.contributor.authorItzkowitz, Steven H.
dc.contributor.authorMay, Folasade P.
dc.contributor.authorLimburg, Paul J.
dc.contributor.authorSweetser, Seth
dc.contributor.authorDaghestani, Anas
dc.contributor.authorBerger, Barry M.
dc.contributor.departmentMedicine, School of Medicine
dc.date.accessioned2023-10-25T11:27:07Z
dc.date.available2023-10-25T11:27:07Z
dc.date.issued2023
dc.description.abstractData supporting the clinical utility of multi-target stool DNA (mt-sDNA) at the guideline-recommended 3-year interval have not been reported.Between April 2015 and July 2016, candidates for colorectal cancer screening whose providers prescribed the mt-sDNA test were enrolled. Participants with a positive baseline test were recommended for colonoscopy and completed the study. Those with a negative baseline test were followed annually for 3 years. In year 3, the mt-sDNA test was repeated and colonoscopy was recommended independent of results. Data were analyzed using the Predictive Summary Index (PSI), a measure of the gain in certainty for dichotomous diagnostic tests (where a positive value indicates a net gain), and by comparing observed versus expected colorectal cancers and advanced precancerous lesions.Of 2,404 enrolled subjects, 2,044 (85%) had a valid baseline mt-sDNA result [284 (13.9%) positive and 1,760 (86.1%) negative]. Following participant attrition, the year 3 intention to screen cohort included 591 of 1,760 (33.6%) subjects with valid mt-sDNA and colonoscopy results, with no colorectal cancers and 63 advanced precancerous lesions [22 (34.9%) detected by mt-sDNA] and respective PSI values of 0% (P = 1) and 9.3% (P = 0.01). The observed 3-year colorectal cancer yield was lower than expected (one-sided P = 0.09), while that for advanced precancerous lesions was higher than expected (two-sided P = 0.009).Repeat mt-sDNA screening at a 3-year interval resulted in a statistically significant gain in detection of advanced precancerous lesions. Due to absence of year 3 colorectal cancers, the PSI estimate for colorectal cancer was underpowered and could not be reliably quantified. Larger studies are required to assess the colorectal cancer study findings. Prevention relevance: Understanding the 3-year yield of mt-sDNA for colorectal cancer and advanced precancerous polyps is required to ensure the clinical appropriateness of the 3-year interval and to optimize mt-sDNA's screening effectiveness.
dc.eprint.versionFinal published version
dc.identifier.citationImperiale TF, Lavin PT, Marti TN, et al. Three-Year Interval for the Multi-Target Stool DNA Test for Colorectal Cancer Screening: A Longitudinal Study. Cancer Prev Res (Phila). 2023;16(2):89-97. doi:10.1158/1940-6207.CAPR-22-0238
dc.identifier.urihttps://hdl.handle.net/1805/36634
dc.language.isoen_US
dc.publisherAmerican Association for Cancer Research
dc.relation.isversionof10.1158/1940-6207.CAPR-22-0238
dc.relation.journalCancer Prevention Research
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internationalen
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0
dc.sourcePMC
dc.subjectColonoscopy
dc.subjectColorectal neoplasms
dc.subjectEarly detection of cancer
dc.subjectFeces
dc.subjectMass screening
dc.subjectPrecancerous conditions
dc.titleThree-Year Interval for the Multi-Target Stool DNA Test for Colorectal Cancer Screening: A Longitudinal Study
dc.typeArticle
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