Multitarget stool DNA test: clinical performance and impact on yield and quality of colonoscopy for colorectal cancer screening - 20/04/17
Abstract |
Background and Aims |
Multitarget stool DNA (MT-sDNA) testing is now approved by the U.S. Food and Drug Administration for average-risk colorectal cancer screening. Trials leading to its approval used blinded colonoscopy as the reference standard. In the postapproval screen setting, the clinical performance and impact of MT-sDNA testing on unblinded colonoscopy has not been described. We measured the impact that knowledge of a positive MT-sDNA test result has on colonoscopy yield and quality.
Methods |
The unblinded group comprised all patients with positive MT-sDNA results on screening from September 1, 2014 to September 30, 2015 at a single tertiary center. Off-label test patients were excluded. The blinded group included all MT-sDNA–positive participants in a preapproval screening study from the same center. Detailed colonoscopy findings and withdrawal times were recorded.
Results |
There were 172 MT-sDNA–positive patients in the unblinded group and 72 in the blinded group. More total adenomatous/sessile serrated polyps (70% vs 53%, P = .013) and advanced neoplasms (28% vs 21%, P = .27) were detected in unblinded than in blinded groups. Median numbers of polyps detected were 2 (IQR, 1-4) and 1 (IQR, 0-2) in unblinded and blinded groups, respectively (P = .0007). Among polyps detected, flat or slightly raised lesions in the right side of the colon were proportionately more frequent with unblinded (40%) than with blinded examinations (9%) (P = .0017). Median withdrawal time was 19 minutes (IQR, 13-29) in the unblinded group compared with 13 minutes (IQR, 10-20) in the blinded group (P = .0001).
Conclusions |
Knowledge of a positive MT-sDNA result appears to have a beneficial impact on the diagnostic yield and quality of subsequent colonoscopy.
Le texte complet de cet article est disponible en PDF.Abbreviaiotns : CRC, CRN, IQR, MT-sDNA, SSA/P
Plan
| DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: J. B. Kisiel, D. A. Ahlquist: Research or grant recipient from Exact Sciences; J. B. Kisiel, D. W. Mahoney, D. A. Ahlquist: potential product royalty/licensing fees from Exact Sciences [Mayo Clinic is a minor equity holder in Exact Sciences and has an intellectual property agreement with Exact Sciences under which inventors, such as Drs Kisiel and Ahlquist and Mr Mahoney, could receive royalties in accordance with Mayo Clinic policy]. All other authors disclosed no financial relationships relevant to this publication. Research support for this study was provided by a grant from the Maxine and Jack Zarrow Family Foundation of Tulsa Oklahoma and the Paul Calabresi Program in Clinical-Translational Research (NCI CA90628), the Carol M. Gatton endowment for Digestive Diseases Research, and Mayo Clinic (J.B.K.). |
Vol 85 - N° 3
P. 657 - mars 2017 Retour au numéro
Article précédent
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