Clinical trial · Interventional
Detection of Colorectal Cancer in Patients With a Positive Fecal Immunochemical Test Using an Electronic Nose Device (AeoNoseTM)
NCT03346005CI-TRIAL-00044024completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present study aims to investigate the diagnostic accuracy of exhaled breath analysis with the Aeonose (the eNose Company, Zutphen, the Netherlands) to distinguish the breath of patients suspected for CRC (based on a positive fecal immunochemical test), who are truly diagnosed with CRC, from patients suspected for CRC in whom this diagnosis is rejected after colonoscopy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Polyps of Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aeonose | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adult patients with positive FIT test
- description
- Adult patients with a positive FIT-test will breath into an e-nose device for 5 minutes.
- interventionNames
- Device: Aeonose
Primary outcomes (1)
- measure
- The ability of AeonoseTM to distinguish between patients with and without colorectal cancer in a FIT-positive population in terms of sensitivity and specificity.
- timeFrame
- 1.5 year
- description
- Sensitivity and specificity of the Aeonose
Secondary outcomes (2)
- measure
- The diagnostic accuracy of AeonoseTM for other (pre-)malignant colon lesions (e.g. advanced adenomas, non-advanced adenomas, and sessile serrated lesions).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients between the ages of 55 and 75 years referred for a colonoscopy procedures after a positive FIT test. Exclusion Criteria: * Patients with a history of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC)) * Prior surgical resection of any portion of the colon * Patients who are unable to perform breathing maneuver needed for Aeonose-analysis of exhaled air
References
Publications (2)
- DERIVEDvan Riswijk MLM, van Keulen KE, Tan ACITL, Schrauwen RWM, de Vos Tot Nederveen Cappel WH, Siersema PD; eNose CRC study group. 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. Aliment Pharmacol Ther. 2025 Jul;62(2):208-213. doi: 10.1111/apt.70207. Epub 2025 Jun 3. PMID 40459533
- DERIVEDvan Riswijk MLM, van Tintelen BFM, Lucas RH, van der Palen J, Siersema PD. Overcoming methodological barriers in electronic nose clinical studies, a simulation data-based approach. J Breath Res. 2025 May 9;19(3). doi: 10.1088/1752-7163/add291. PMID 40306296