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Optimizing Screening for Colorectal Cancer: An Algorithm Combining Fecal Immunochemical Test, Blood-Based

Mathias M Petersen1, Jakob Kleif2, Lars N Jørgensen3

  • 1Gastro Unit, Hvidovre Hospital, Hvidovre, Denmark; Institute for Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.

Clinical Colorectal Cancer
|March 6, 2023
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Summary

A new algorithm combining Fecal Immunochemical Test (FIT) results, blood biomarkers, and demographics improves colorectal cancer (CRC) detection in screening populations. This approach enhances diagnostic accuracy and helps manage colonoscopy capacity.

Keywords:
BiomarkersColorectal neoplasiaEarly detectionLogistic regression modelingMinimal invasive liquid biopsy

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Area of Science:

  • Oncology
  • Biomarker Discovery
  • Clinical Diagnostics

Background:

  • Fecal Immunochemical Test (FIT) is a cornerstone of population-based colorectal cancer (CRC) screening.
  • High FIT positivity rates present challenges to colonoscopy capacity, necessitating improved triage strategies.
  • There is a need for sensitive methods to identify CRC without overwhelming diagnostic resources.

Purpose of the Study:

  • To investigate an algorithm combining FIT results, blood biomarkers, and demographics for improved CRC detection.
  • To assess the algorithm's ability to triage individuals within a FIT-positive screening cohort.
  • To reduce the burden on colonoscopy services by optimizing patient selection.

Main Methods:

  • Analysis of 4048 FIT-positive subjects (≥100 ng/mL Hemoglobin) from the Danish National Colorectal Cancer Screening Program.
  • Development of two algorithms: one predefined (FIT, age, CEA, hsCRP, Ferritin) and one exploratory (adding TIMP-1, Pepsinogen-2, HE4, CyFra21-1, Galectin-3, B2M, sex).
  • Benchmarking diagnostic performance against FIT alone using logistic regression and Area Under the Curve (AUC) analysis.

Main Results:

  • The predefined algorithm achieved an AUC of 73.7%, and the exploratory algorithm achieved 75.3%, significantly outperforming FIT alone (AUC 68.9%).
  • Both algorithms demonstrated improved performance metrics across various FIT cutoffs (100-500 ng/mL Hemoglobin).
  • The combined approach showed superior discrimination of CRC cases compared to FIT alone.

Conclusions:

  • A screening algorithm integrating FIT, blood biomarkers, and demographics is more effective than FIT alone for identifying CRC in FIT-positive individuals.
  • This multi-analyte approach offers a promising strategy for enhancing CRC screening efficiency.
  • The developed algorithm can aid in better triaging patients for colonoscopy, optimizing resource allocation.