Multitarget stool DNA test: Clinical performance and impact on yield and quality of colonoscopy for colorectal cancer screening

David H. Johnson, John B Kisiel, Kelli N. Burger, Douglas W. Mahoney, Mary E. Devens, David A. Ahlquist, Seth Sweetser

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish (US)
JournalGastrointestinal Endoscopy
DOIs
StateAccepted/In press - Jun 27 2016

Fingerprint

Colonoscopy
Early Detection of Cancer
Colorectal Neoplasms
DNA
Polyps
United States Food and Drug Administration
Colon
Neoplasms

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

Multitarget stool DNA test : Clinical performance and impact on yield and quality of colonoscopy for colorectal cancer screening. / Johnson, David H.; Kisiel, John B; Burger, Kelli N.; Mahoney, Douglas W.; Devens, Mary E.; Ahlquist, David A.; Sweetser, Seth.

In: Gastrointestinal Endoscopy, 27.06.2016.

Research output: Contribution to journalArticle

Johnson, David H. ; Kisiel, John B ; Burger, Kelli N. ; Mahoney, Douglas W. ; Devens, Mary E. ; Ahlquist, David A. ; Sweetser, Seth. / Multitarget stool DNA test : Clinical performance and impact on yield and quality of colonoscopy for colorectal cancer screening. In: Gastrointestinal Endoscopy. 2016.
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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.",
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