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@ARTICLE{Brenner:143636,
author = {H. Brenner$^*$ and S. Calderazzo$^*$ and T. Seufferlein and
L. Ludwig and N. Dikopoulos and J. Mangold and W. Böck and
T. Stolz and T. Eisenbach and T. Block and A.
Kopp-Schneider$^*$ and D. Czock and K. Tikk$^*$},
title = {{E}ffect of a {S}ingle {A}spirin {D}ose {P}rior to {F}ecal
{I}mmunochemical {T}esting on {T}est {S}ensitivity for
{D}etecting {A}dvanced {C}olorectal {N}eoplasms: {A}
{R}andomized {C}linical {T}rial.},
journal = {The journal of the American Medical Association},
volume = {321},
number = {17},
issn = {0098-7484},
address = {Chicago, Ill.},
publisher = {American Medical Association},
reportid = {DKFZ-2019-01213},
pages = {1686 - 1692},
year = {2019},
abstract = {Fecal immunochemical tests for hemoglobin are widely used
for colorectal cancer (CRC) screening. Observational studies
suggested that sensitivity of fecal immunochemical tests for
detecting advanced neoplasms could be increased by
acetylsalicylic acid (aspirin), especially among men.To
evaluate the potential to increase sensitivity of fecal
immunochemical tests by administering a single 300-mg oral
aspirin dose 2 days before stool sampling.A randomized,
placebo-controlled, double-blind trial was conducted in 14
gastroenterology practices and 4 hospitals in Germany, and
included 2422 men and women aged 40 to 80 years scheduled
for colonoscopy, with no recent use of aspirin or other
drugs with antithrombotic effects (enrollment from June 2013
to November 2016, and final follow-up January 27,
2017).Administration of a single tablet containing 300 mg of
aspirin (n = 1208) or placebo (n = 1214) 2 days
before fecal sampling for fecal immunochemical test.The
primary outcome was sensitivity of a quantitative fecal
immunochemical test at 2 predefined cutoffs (10.2 and 17-μg
Hb/g stool) for detecting advanced neoplasms (colorectal
cancer or advanced adenoma).Among 2422 randomized patients
(mean [SD] age, 59.6 [7.9] years; 1219, $50\%,$ men), 2134
were included in the analysis $(78\%$ for primary screening
colonoscopy, $22\%$ for diagnostic colonoscopy). Advanced
neoplasms were identified in 224 participants $(10.5\%),$
including 8 participants $(0.4\%)$ with CRC and 216
participants $(10.1\%)$ with advanced adenoma. Sensitivity
was $40.2\%$ in the aspirin group and $30.4\%$ in the
placebo group (difference $9.8\%,$ $95\%$ CI, $-3.1\%$ to
$22.2\%,$ P = .14) at cutoff 10.2-μg Hb/g stool and
$28.6\%$ in the aspirin and $22.5\%$ in the placebo group
(difference $6.0\%,$ $95\%$ CI, $-5.7\%$ to $17.5\%,$
P = .32) at cutoff 17-μg Hb/g stool.Among adults aged
40 to 80 years not using aspirin or other antithrombotic
medications, administration of a single dose of oral aspirin
prior to fecal immunochemical testing, compared with
placebo, did not significantly increase test sensitivity for
detecting advanced colorectal neoplasms at 2 predefined
cutoffs of a quantitative fecal immunochemical
test.Deutsches Register Klinischer Studien Identifier:
DRKS00003252; EudraCT Identifier: 2011-005603-32/DE.},
cin = {C070 / C120 / C060 / L101},
ddc = {610},
cid = {I:(DE-He78)C070-20160331 / I:(DE-He78)C120-20160331 /
I:(DE-He78)C060-20160331 / I:(DE-He78)L101-20160331},
pnm = {313 - Cancer risk factors and prevention (POF3-313)},
pid = {G:(DE-HGF)POF3-313},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:31063574},
doi = {10.1001/jama.2019.4755},
url = {https://inrepo02.dkfz.de/record/143636},
}