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Clinical performance study of a fecal bacterial signature test for colorectal cancer screening

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...

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Autores principales: Malagón, Marta, Alwers, Elizabeth, Oliver, Lia, Ramió-Pujol, Sara, Sánchez-Vizcaino, Mireia, Amoedo, Joan, de Cambra, Salomé, Serra-Pagès, Mariona, Castells, Antoni, Aldeguer, Xavier, Garcia-Gil, Jesús, Brenner, Hermann
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10664962/
https://www.ncbi.nlm.nih.gov/pubmed/37992030
http://dx.doi.org/10.1371/journal.pone.0293678
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author Malagón, Marta
Alwers, Elizabeth
Oliver, Lia
Ramió-Pujol, Sara
Sánchez-Vizcaino, Mireia
Amoedo, Joan
de Cambra, Salomé
Serra-Pagès, Mariona
Castells, Antoni
Aldeguer, Xavier
Garcia-Gil, Jesús
Brenner, Hermann
author_facet Malagón, Marta
Alwers, Elizabeth
Oliver, Lia
Ramió-Pujol, Sara
Sánchez-Vizcaino, Mireia
Amoedo, Joan
de Cambra, Salomé
Serra-Pagès, Mariona
Castells, Antoni
Aldeguer, Xavier
Garcia-Gil, Jesús
Brenner, Hermann
author_sort Malagón, Marta
collection PubMed
description 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.
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spelling pubmed-106649622023-11-22 Clinical performance study of a fecal bacterial signature test for colorectal cancer screening Malagón, Marta Alwers, Elizabeth Oliver, Lia Ramió-Pujol, Sara Sánchez-Vizcaino, Mireia Amoedo, Joan de Cambra, Salomé Serra-Pagès, Mariona Castells, Antoni Aldeguer, Xavier Garcia-Gil, Jesús Brenner, Hermann PLoS One Research Article 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. Public Library of Science 2023-11-22 /pmc/articles/PMC10664962/ /pubmed/37992030 http://dx.doi.org/10.1371/journal.pone.0293678 Text en © 2023 Malagón et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Malagón, Marta
Alwers, Elizabeth
Oliver, Lia
Ramió-Pujol, Sara
Sánchez-Vizcaino, Mireia
Amoedo, Joan
de Cambra, Salomé
Serra-Pagès, Mariona
Castells, Antoni
Aldeguer, Xavier
Garcia-Gil, Jesús
Brenner, Hermann
Clinical performance study of a fecal bacterial signature test for colorectal cancer screening
title Clinical performance study of a fecal bacterial signature test for colorectal cancer screening
title_full Clinical performance study of a fecal bacterial signature test for colorectal cancer screening
title_fullStr Clinical performance study of a fecal bacterial signature test for colorectal cancer screening
title_full_unstemmed Clinical performance study of a fecal bacterial signature test for colorectal cancer screening
title_short Clinical performance study of a fecal bacterial signature test for colorectal cancer screening
title_sort clinical performance study of a fecal bacterial signature test for colorectal cancer screening
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10664962/
https://www.ncbi.nlm.nih.gov/pubmed/37992030
http://dx.doi.org/10.1371/journal.pone.0293678
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