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@ARTICLE{Malagn:285567,
author = {M. Malagón and E. Alwers$^*$ and L. Oliver and S.
Ramió-Pujol and M. Sánchez-Vizcaino and J. Amoedo and S.
de Cambra and M. Serra-Pagès and A. Castells and X.
Aldeguer and J. Garcia-Gil and H. Brenner$^*$},
title = {{C}linical performance study of a fecal bacterial signature
test for colorectal cancer screening.},
journal = {PLOS ONE},
volume = {18},
number = {11},
issn = {1932-6203},
address = {San Francisco, California, US},
publisher = {PLOS},
reportid = {DKFZ-2023-02433},
pages = {e0293678 -},
year = {2023},
note = {#LA:C070#LA:C120#},
abstract = {The fecal immunochemical test (FIT) is the most widely used
test for colorectal cancer (CRC) screening. RAID-CRC Screen
is a new non-invasive test based on fecal bacterial markers,
developed to complement FIT by increasing its specificity.
The test was previously clinically evaluated in FIT-positive
patients (>20 μg of hemoglobin/g of feces, 'FIT20'), in
which it reduced the proportion of false positive results by
$16.3\%$ while maintaining most of FIT20's sensitivity. The
aim of this study was to compare the sensitivity and
specificity of a CRC screening program using RAID-CRC Screen
in addition to FIT20 as a triage test in a European
screening population undergoing screening colonoscopy with a
CRC screening program with FIT20 alone in the same cohort. A
cohort of 2481 subjects aged > 55 years from the German
screening colonoscopy program was included. The colonoscopy
findings were used as the gold standard in calculating the
diagnostic capacity of the tests and included 15 CRC and 257
advanced neoplasia cases. RAID-CRC Screen added to FIT20
provided the same sensitivity as FIT20 alone $(66.7\%)$ in
detecting CRC and a significantly higher specificity
$(97.0\%$ vs. $96.1\%,$ p<0.0001). The positive predictive
value was $11.9\%$ when using RAID-CRC Screen and $9.5\%$
with FIT20 alone, and the negative predictive value was
$99.8\%$ in the two scenarios. For advanced neoplasia
detection, the use of RAID-CRC Screen yielded significantly
lower sensitivity than with FIT20 alone $(17.5\%$ vs.
$21.8\%,$ p = 0.0009), and the overall specificity was
significantly higher when using RAID-CRC Screen compared
with FIT20 alone $(98.2\%$ vs. $97.8\%,$ p = 0.0039). Our
findings confirm the results obtained in previous clinical
studies in a CRC screening setting, showing the potential of
RAID-CRC Screen to increase the overall specificity of
FIT-based screening.},
cin = {C070 / C120 / HD01},
ddc = {610},
cid = {I:(DE-He78)C070-20160331 / I:(DE-He78)C120-20160331 /
I:(DE-He78)HD01-20160331},
pnm = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
pid = {G:(DE-HGF)POF4-313},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:37992030},
doi = {10.1371/journal.pone.0293678},
url = {https://inrepo02.dkfz.de/record/285567},
}