Three-Year Interval for the Multi-Target Stool DNA Test for Colorectal Cancer Screening: A Longitudinal Study
dc.contributor.author | Imperiale, Thomas F. | |
dc.contributor.author | Lavin, Philip T. | |
dc.contributor.author | Marti, Tara N. | |
dc.contributor.author | Jakubowski, Debbie | |
dc.contributor.author | Itzkowitz, Steven H. | |
dc.contributor.author | May, Folasade P. | |
dc.contributor.author | Limburg, Paul J. | |
dc.contributor.author | Sweetser, Seth | |
dc.contributor.author | Daghestani, Anas | |
dc.contributor.author | Berger, Barry M. | |
dc.contributor.department | Medicine, School of Medicine | |
dc.date.accessioned | 2023-10-25T11:27:07Z | |
dc.date.available | 2023-10-25T11:27:07Z | |
dc.date.issued | 2023 | |
dc.description.abstract | Data 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.version | Final published version | |
dc.identifier.citation | Imperiale 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.uri | https://hdl.handle.net/1805/36634 | |
dc.language.iso | en_US | |
dc.publisher | American Association for Cancer Research | |
dc.relation.isversionof | 10.1158/1940-6207.CAPR-22-0238 | |
dc.relation.journal | Cancer Prevention Research | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International | en |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0 | |
dc.source | PMC | |
dc.subject | Colonoscopy | |
dc.subject | Colorectal neoplasms | |
dc.subject | Early detection of cancer | |
dc.subject | Feces | |
dc.subject | Mass screening | |
dc.subject | Precancerous conditions | |
dc.title | Three-Year Interval for the Multi-Target Stool DNA Test for Colorectal Cancer Screening: A Longitudinal Study | |
dc.type | Article |