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

Author

Listed:
  • Marta Malagón
  • Elizabeth Alwers
  • Lia Oliver
  • Sara Ramió-Pujol
  • Mireia Sánchez-Vizcaino
  • Joan Amoedo
  • Salomé de Cambra
  • Mariona Serra-Pagès
  • Antoni Castells
  • Xavier Aldeguer
  • Jesús Garcia-Gil
  • Hermann Brenner

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

Suggested Citation

  • Marta Malagón & Elizabeth Alwers & Lia Oliver & Sara Ramió-Pujol & Mireia Sánchez-Vizcaino & Joan Amoedo & Salomé de Cambra & Mariona Serra-Pagès & Antoni Castells & Xavier Aldeguer & Jesús Garcia-Gil, 2023. "Clinical performance study of a fecal bacterial signature test for colorectal cancer screening," PLOS ONE, Public Library of Science, vol. 18(11), pages 1-12, November.
    • Handle: RePEc:plo:pone00:0293678
    DOI: 10.1371/journal.pone.0293678
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    References listed on IDEAS

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    1. Wendy Leisenring & Todd Alono & Margaret Sullivan Pepe, 2000. "Comparisons of Predictive Values of Binary Medical Diagnostic Tests for Paired Designs," Biometrics, The International Biometric Society, vol. 56(2), pages 345-351, June.
    2. Gu Wen & Pepe Margaret, 2009. "Measures to Summarize and Compare the Predictive Capacity of Markers," The International Journal of Biostatistics, De Gruyter, vol. 5(1), pages 1-49, October.
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