Breath Analysis as an Additional Test for Colorectal Cancer Screening to Reduce the Number of Unnecessary Colonoscopies

NCT04357158 | Completed

• 1 other identifier: '2020-6184'
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

In the past decade, the demand for colonoscopy procedures has increased significantly since the introduction of population-based colorectal cancer (CRC) screening in many western countries. Post-polypectomy surveillance will increase the number of colonoscopy procedures conducted each year even further. The invasive nature of colonoscopy and the associated health-care costs warrant the development of a new non-invasive test to reduce the number of unnecessary colonoscopies. These days, many countries use a non-invasive fecal test for CRC screening which is easy to perform at home, but test characteristics such as sensitivity and specificity are suboptimal. Multiple studies have already shown that volatile organic compound (VOC) analysis has a high diagnostic accuracy for CRC and Advanced Adenomas. An additional VOC analysis, for example through breath testing, in patients with a positive fecal immunochemical test (FIT) may reduce the number of unnecessary colonoscopies. The aim of this study is to validate the diagnostic accuracy of the AeonoseTM to distinguish patients with CRC from healthy controls, and to assess reproducibility of test results.

Conditions

Colorectal Cancer; Polyp of Colon; Colorectal Neoplasms

Keywords

Volatile organic compounds; VOC; Colorectal cancer; Advanced adenoma; Breath test; Electronic nose; eNose; Aeonose

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy in distinguishing colorectal carcinoma from healthy controls

  The diagnostic accuracy, in terms of sensitivity and specificity, of the AeonoseTM in distinguishing between patients with and without CRC.

  12 months

Secondary Outcomes (3)

• Diagnostic accuracy in distinguishing advanced adenoma from healthy controls

  12 months

• Reproducibility

  12 months

• Acceptance rate

  12 months

Study Arms (1)

Patients referred for colonoscopy

OTHER

Device: AeonoseTM

Interventions

AeonoseTM DEVICE

All participants will be asked to breathe into an electronic nose (eNose, the AeonoseTM, The eNose Company, Zutphen, the Netherlands) for 5 minutes during the pre-colonoscopy intake and just prior to the procedure to assess reproducibility (with \>2 weeks in between).

Patients referred for colonoscopy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients between the ages of 55 and 75 years referred for a colonoscopy procedure after a positive FIT test, according to the population based CRC screening program in the Netherlands

You may not qualify if:

• Prior surgical resection of any portion of the colon
• History of any type of malignancy, not including squamous cell carcinoma (SCC) and basal cell carcinoma (BCC)
• Current active colitis or history of polyposis syndrome

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525GA, 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: 40459533 DERIVED

• 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: 40306296 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter D Siersema, MD, PhD

  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

Model Details: This is a multicenter prospective cohort study in participants eligible for colonoscopy with suspicion for (pre)malignant lesions of the colon

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: May 25, 2020
• Primary Completion: January 5, 2022
• Study Completion: July 5, 2022
• Last Updated: November 21, 2024

Record last verified: 2021-09

Locations

NL (1)