@article{03ae804557334ea5b2ce27edbc58687d,
title = "Stool DNA Testing for Screening Detection of Colorectal Neoplasia in Alaska Native People",
abstract = "Objective To assess the accuracy of a multitarget stool DNA test (MT-sDNA) compared with fecal immunochemical testing for hemoglobin (FIT) for detection of screening-relevant colorectal neoplasia (SRN) in Alaska Native people, who have among the world's highest rates of colorectal cancer (CRC) and limited access to conventional screening approaches. Patients and Methods We performed a prospective, cross-sectional study of asymptomatic Alaska Native adults aged 40-85 years and older undergoing screening or surveillance colonoscopy between February 6, 2012, and August 7, 2014. Results Among 868 enrolled participants, 661 completed the study (403 [61%] women). Overall, SRN detection by MT-sDNA (49%) was superior to that by FIT (28%; P<.001); in the screening group, SRN detection rates were 50% and 31%, respectively (P=.01). Multitarget stool DNA testing detected 62% of adenomas 2 cm or larger vs 29% by FIT (P=.05). Sensitivity by MT-sDNA increased with adenoma size (to 80% for lesions ≥3 cm; P=.01 for trend) and substantially exceeded FIT sensitivity at all adenoma sizes. For sessile serrated polyps larger than 1 cm (n=9), detection was 67% by MT-sDNA vs 11% by FIT (P=.07). For CRC (n=10), detection was 100% by MT-sDNA vs 80% by FIT (P=.48). Specificities were 93% and 96%, respectively (P=.03). Conclusion The sensitivity of MT-sDNA for cancer and larger polyps was high and significantly greater than that of FIT for polyps of any size, while specificity was slightly higher with FIT. These findings could translate into high cumulative neoplasm detection rates on serial testing within a screening program. The MT-sDNA represents a potential strategy to expand CRC screening and reduce CRC incidence and mortality, especially where access to endoscopy is limited.",
author = "Redwood, {Diana G.} and Asay, {Elvin D.} and Blake, {Ian D.} and Sacco, {Pamela E.} and Christensen, {Claudia M.} and Sacco, {Frank D.} and Tiesinga, {James J.} and Devens, {Mary E.} and Alberts, {Steven R.} and Mahoney, {Douglas W.} and Yab, {Tracy C.} and Foote, {Patrick H.} and Smyrk, {Thomas C.} and Provost, {Ellen M.} and Ahlquist, {David A.}",
note = "Funding Information: We thank the Alaska Native Tribal Health Consortium Board of Directors, the Southcentral Foundation Board of Directors, and the Mayo Clinic Comprehensive Cancer Center for infrastructural support and quality reviews. We thank Exact Sciences Corporation, which provided stool collection materials and performed MT-sDNA assays at no cost. Exact Sciences Corporation had no role in the study design, data analyses, or manuscript preparation. In particular, we are grateful to Dr Barry Berger, Chief Medical Officer, and Dr Graham Lidgard, Chief Scientific Officer, who assisted with logistics of stool collection and testing. We also thank Dr Paul Davis at the ANMC for endoscopy assistance and Evon Otto, RN, and Cindy Hamlin, RN, for assistance with study recruitment. Drs Redwood and Ahlquist reviewed analysis of unblinded data with the statisticians and take responsibility for the integrity and analyses of the data. Contributions of authors: Diana G. Redwood, PhD, protocol management, analysis and interpretation of data, codrafting of the submitted manuscript; Elvin D. Asay, MS, database creation, statistical analysis; Ian D. Blake MS, database management, statistical analysis; Pamela E. Sacco, RN, study coordination and technical support; Claudia M. Christensen, ANP, clinical administration and technical support; Frank D. Sacco, MD, clinical oversight and technical support; James J. Tiesinga, MD, laboratory administration and technical support; Mary E. Devens, BA, protocol management, database creation, quality monitoring; Steven R. Alberts, MD, technical support; Douglas W. Mahoney, MS, study design and sample size estimation, statistical analysis and interpretation of data, critical review of submitted manuscript; Tracy C. Yab, BS, laboratory administration and technical support; Patrick H. Foote, MD, technical support; Thomas C. Smyrk, MD, clinical administration and technical support; Thomas C. Provost, DO, study concept and design, study oversight, critical review of submitted manuscript; David A. Ahlquist, MD, study concept and design, analysis and interpretation of data, codrafting of the submitted manuscript, acquisition of funding, study oversight. ",
year = "2016",
month = jan,
day = "1",
doi = "10.1016/j.mayocp.2015.10.008",
language = "English (US)",
volume = "91",
pages = "61--70",
journal = "Mayo Clinic Proceedings",
issn = "0025-6196",
publisher = "Elsevier Science",
number = "1",
}