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Diagnostic yield of a risk model versus faecal immunochemical test only: a randomised controlled trial in a colorectal cancer screening programme

British Journal of Cancer volume 129, pages 791–796 (2023)Cite this article

Subjects

Abstract

Background

Combining the faecal immunochemical test (FIT) result with risk factors for advanced neoplasia (AN) may increase the yield of colorectal cancer (CRC) screening without increasing the number of colonoscopies. We conducted a randomised controlled trial in the Dutch CRC screening programme to evaluate a previously developed risk model including FIT, age, sex, smoking status, and CRC family history.

Methods

A total of 22,748 individuals aged 56–75 years were pre-randomised to the risk-model group or the FIT-only group. Both groups received the FIT; those allocated to the risk-model group also received a single-page questionnaire. Study participants with a positive result (FIT ≥ 15 µg Hb/g faeces and/or risk ≥0.10) were referred for colonoscopy. The primary outcome measure was the proportion of invitees in whom AN was detected.

Results

In the risk-model group, 3113/11,364 invitees (27%) returned the FIT and questionnaire versus 3061/11,384 invitees (27%) in the FIT-only group (p = 0.40). The yield of AN was 3.70/1000 invitees in the risk-model group versus 3.43/1000 in the FIT-only group (absolute difference: 0.27/1000, 95%CI: −1.30 to 1.82, p = 0.82).

Conclusions

Combining FIT with risk factors for CRC did not increase the yield of AN compared to FIT-only in an existing CRC screening programme. There was no difference in participation between groups.

Clinical trial registration

NCT04490551 (ClinicalTrials.gov).

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Fig. 1: Flowchart of the study population.
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Data availability

Study data cannot be shared publicly, but access can be requested via the Netherlands Institute of Public Health and the Environment (RIVM). Analytic methods can be shared by the authors on request.

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Acknowledgements

We would like to express our gratitude to the Foundation of Population Screening Mid-West Netherlands, in particular to Erwin Humer, Maja Groothuis, and Toos Portegies–te Brake, for their effort in enabling this study to be carried out. We also like to thank Frejanne van Maaren–Meijer for her assistance in data acquisition. Third, we would like to thank all staff of the endoscopy unit of Bergman Clinics, location IZA, and in particular, Mariska Rustenburg.

Funding

This study was supported by the Netherlands Organisation for Health Research and Development (ZonMw). ZonMw had no role in the study design; data collection, analysis, or interpretation; in the writing of the report, and in the decision to submit the paper for publication.

Author information

Authors and Affiliations

  1. Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands

    Tim L. Kortlever, Manon van der Vlugt & Evelien Dekker

  2. Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands

    Tim L. Kortlever, Manon van der Vlugt & Evelien Dekker

  3. Cancer Center Amsterdam, Amsterdam, The Netherlands

    Tim L. Kortlever, Manon van der Vlugt & Evelien Dekker

  4. Bergman Clinics, location IZA, Amsterdam, The Netherlands

    Manon van der Vlugt & Evelien Dekker

  5. Department of Human Genetics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands

    Floor A. M. Duijkers

  6. Department of Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, The Netherlands

    Ad Masclee

  7. Netherlands Institute for Prevention and E-health Development (NIPED), Amsterdam, The Netherlands

    Roderik Kraaijenhagen

  8. Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands

    Manon C. W. Spaander

  9. Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands

    Iris Lansdorp-Vogelaar

  10. Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Amsterdam Public Health, University of Amsterdam, Amsterdam, The Netherlands

    Patrick M. Bossuyt

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  1. Tim L. Kortlever
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Contributions

ED, PB, and MV conceived and designed this study. AM, ILV, MS, and RK participated in meetings discussing the design of the study. TK enrolled participants and collected the data. ED, PB, and MV supervised the study and data collection. TK, PB, ED, and MV contributed to data analysis and interpretation. TK drafted the manuscript. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. TK and PB accessed and verified the data.

Corresponding author

Correspondence to Evelien Dekker.

Ethics declarations

Competing interests

AM received financial support from Pentax Europe. MS received material and financial support from Sentinel, Sysmex, and Medtronic. ED received endoscopic equipment on loan from FujiFilm and Olympus, received a research grant from FujiFilm, received honorarium for consultancy from FujiFilm, Olympus, GI Supply, CPP-FAP, PAION, and Ambu, and speakers’ fees from Olympus, GI Supply, Norgine, IPSEN, PAION, and FujiFilm. The remaining authors disclose no conflicts.

Ethics approval and consent to participate

This study was approved by the Dutch Health Council according to the law on population screening. Written informed consent was required for study enrolment. The study was performed in accordance with the Declaration of Helsinki.

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Kortlever, T.L., van der Vlugt, M., Duijkers, F.A.M. et al. Diagnostic yield of a risk model versus faecal immunochemical test only: a randomised controlled trial in a colorectal cancer screening programme. Br J Cancer 129, 791–796 (2023). https://doi.org/10.1038/s41416-023-02358-z

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