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Multicenter Study
. 2025 Jul;62(2):208-213.
doi: 10.1111/apt.70207. Epub 2025 Jun 3.

Research Communication: Breath Testing for Colorectal Cancer Detection in Patients With a Positive Fecal Immunochemical Test: A Multicentre Prospective Cross-Sectional Study With External Validation

Milou L M van Riswijk  1 , Kelly E van Keulen  1 , Adriaan C I T L Tan  2 , Ruud W M Schrauwen  3 , Wouter H de Vos Tot Nederveen Cappel  4 , Peter D Siersema  1   5 ; eNose CRC study group
Collaborators, Affiliations
Multicenter Study

Research Communication: Breath Testing for Colorectal Cancer Detection in Patients With a Positive Fecal Immunochemical Test: A Multicentre Prospective Cross-Sectional Study With External Validation

Milou L M van Riswijk et al. Aliment Pharmacol Ther. 2025 Jul.

Abstract

Colorectal cancer (CRC) screening using fecal immunochemical tests (FIT) is suboptimal. This multicentre study evaluated an electronic nose (e-nose) for CRC detection in FIT-positive patients, along with reproducibility and external validation. Among 3469 participants (40.1% female, median age 64.3y), CRC was diagnosed in 5.0%; 25.1% had a normal colonoscopy. The e-nose showed poor diagnostic performance (AUC 0.542; sensitivity 39.5%; specificity 68.3%) and low reproducibility (ICC 0.22). Despite high patient acceptability (95.3% willingness-to-repeat), these findings suggest e-nose technology is not yet ready for clinical implementation. Further research is needed to standardise and validate e-nose devices before supplementing current screening methods. Clinicaltrials.gov Identifier NCT03346005 and NCT04357158.

Keywords: colonoscopy; colorectal cancer; electronic nose; screening; surveillance; volatile organic compounds.

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Conflict of interest statement

This study is investigator‐initiated and was funded by the Dutch Digestive Foundation (MLDS) and European Union (EFRO). The e‐nose devices (Aeonose, the eNose company, Zutphen, the Netherlands) were provided by the manufacturer for this study without cost.

Author P.S. receives unrestricted grants from Pentax (Japan), FujiFilm (Japan), Norgine (UK), MicroTech (China) and Magentiq Eye (Israel) and is on the advisory board of Sanofi (The Netherlands). Medical Specialists Company Isala (MSB Isala) invested in the eNose Company, Zutphen, the Netherlands. Author W.d.V.t.N.C. is a member of the MSB but declared to renounce potential future profits of the eNose Company in person. Authors M.R., K.K., A.T. and R.S. declare no competing interests.

Figures

FIGURE 1
FIGURE 1
Receiver operating characteristics (ROC) curve of e‐nose blind predictions in a dataset containing only CRC, advanced adenoma (AA) and control patients. A: CRC versus control. B: CRC versus non CRC. C: AA versus control. D: AA versus non AA. E: AA versus non AA excluding CRC patients.
See this image and copyright information in PMC

References

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