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COLOFIT: Development and Internal-External Validation of Models Using Age, Sex, Faecal Immunochemical and Blood Tests to Optimise Diagnosis of Colorectal Cancer in Symptomatic Patients

Lookup NU author(s): Professor Colin Rees

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2025 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. Background: Colorectal cancer (CRC) is the third most common cancer in the United Kingdom and the second largest cause of cancer death. Aim: To develop and validate a model using available information at the time of faecal immunochemical testing (FIT) in primary care to improve selection of symptomatic patients for CRC investigations. Methods: We included all adults (≥ 18 years) referred to Nottingham University Hospitals NHS Trust between 2018 and 2022 with symptoms of suspected CRC who had a FIT. Predicted 1-year CRC diagnosis were calculated, and externally validated, using Cox proportional hazards modelling with selected multiple fractional polynomial transformations for age, faecal haemoglobin concentration (f-Hb) value, mean corpuscular volume (MCV), platelet count and sex. Results: At a CRC risk threshold of 0.6% (equivalent to f-Hb = 10 μg Hb/g (μg/g)) overall performance of the validated model across age strata using Harrell's C index was ≥ 0.91% (overall C-statistic 93%, 95% CI 92%–95%) with acceptable calibration. Using this model yields similar numbers of detected and missed cancers, but requires ~20% fewer investigations than a f-Hb ≥ 10 μg/g strategy. For approximately 100,000 people per year with symptoms of suspected CRC, we predict it might save > 4500 colonoscopies with no evidence that more cancers would be missed if we used our model compared to using FIT f-Hb ≥ 10 μg/g. Conclusions: Including age, sex, MCV, platelets and f-Hb in a survival analysis model to predict the risk of CRC yields greater diagnostic utility than a simple binary cut off f-Hb ≥ 10 μg/g.


Publication metadata

Author(s): Crooks CJ, West J, Jones J, Hamilton W, Bailey SER, Abel G, Banerjea A, Rees CJ, Tamm A, Nicholson BD, Benton SC, Hunt N, Humes DJ

Publication type: Article

Publication status: Published

Journal: Alimentary Pharmacology and Therapeutics

Year: 2025

Pages: Epub ahead of print

Online publication date: 07/01/2025

Acceptance date: 14/12/2024

Date deposited: 21/01/2025

ISSN (print): 0269-2813

ISSN (electronic): 1365-2036

Publisher: John Wiley and Sons Inc.

URL: https://doi.org/10.1111/apt.18459

DOI: 10.1111/apt.18459

Data Access Statement: The data that support the findings of this study are available within the NHS. Restrictions apply to the availability of these data, which were used under license for this study.


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Funding

Funder referenceFunder name
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (Project number 133852)

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