NCT03346005

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,345

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

November 14, 2017

Last Update Submit

March 12, 2020

Conditions

Colorectal CancerPolyps of Colon

Outcome Measures

Primary Outcomes (1)

  • The ability of AeonoseTM to distinguish between patients with and without colorectal cancer in a FIT-positive population in terms of sensitivity and specificity.

    Sensitivity and specificity of the Aeonose

    1.5 year

Secondary Outcomes (2)

  • The diagnostic accuracy of AeonoseTM for other (pre-)malignant colon lesions (e.g. advanced adenomas, non-advanced adenomas, and sessile serrated lesions).

    1.5 year

  • Acceptance rate of AeonoseTM.

    1.5 year

Study Arms (1)

Adult patients with positive FIT test

EXPERIMENTAL

Adult patients with a positive FIT-test will breath into an e-nose device for 5 minutes.

Device: Aeonose

Interventions

AeonoseDEVICE

An electronic nose device is an artificial olfactory system that analyses volate organic compounds (VOCs) in exhaled breath. The AeonoseTM is a handheld device of 650 gram. A nose clip will be used to prevent the entry of non-filtered air and patients will be instructed to enclose the mouthpiece with their mouth at all times. A measurement cycle lasts for about 15 minutes, of which 5 minutes of in-and exhalation by the patient takes place.

Adult patients with positive FIT test

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients between the ages of 55 and 75 years referred for a colonoscopy procedures after a positive FIT test.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University hospital

Nijmegen, Gelderland, 6525, Netherlands

Location

Related Publications (2)

  • van 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: 40459533DERIVED

  • van 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: 40306296DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Polyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Peter D Siersema, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

November 9, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 16, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)