e-Nose and Colorectal Cancer

NCT ID: NCT03488537

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 511 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2019-12-31

Brief Summary

Colorectal cancer (CRC) is the third most common new cancer diagnosis and a major cause of morbidity and mortality throughout the world. Early detection and treatment are critical factors in the course and prognosis of CRC, and screening programs have proven to be an important means to reduce both CRC related mortality and secondary economic burden.

The diagnostic accuracy of non-invasive screening tests is still limited and a follow-up colonoscopy is required for confirmation of the diagnosis. The faecal occult blood test (FIT) is the most commonly used fecal screening test worldwide, but sensitivity for CRC ranges between 53%-99% depending on the cut-off values used, whereas sensitivity for advanced adenomas is disturbingly low (39%-57%).

The aim of this study is to evaluate the diagnostic accuracy of the AeonoseTM to distuinguish people with CRC from healthy controls.

Detailed Description

Rationale: An electronic nose (eNose) is an artificial olfactory system that analyses volate organic compounds (VOCs) in exhaled breath. Exhaled human breath is mainly composed of inorganic compounds, inert gases and VOCs. VOCs are exhaled in very low concentrations and reflect pathological processes such as inflammation, oxidation, infection and neoplasms. The perspective is that metabolic and biochemical processes in several pathological situations cause different endogenous VOCs to arise, were they can serve as non-invasive biomarkers for certain diseases.

Primary objective: To evaluate the diagnostic accuracy of the AeonoseTM to distinguish the breathing pattern from patients with colorectal cancer from healthy controls using the previously established breathing pattern.

Secondary objecitves:

• To evaluate the diagnostic accuracy of the AeonoseTM to distinguish the breathing pattern from patients with polyps (e.g. advanced adenomas, sessile serrated lesions).
• To determine the influence of colonic cleansing (laxative use) on breathing patterns.

Study population: Adult patients referred for colonoscopy.

Estimated sample size: 66 patients with CRC.

Intervention: Participants will be asked to breath through the AeonoseTM for 5 minutes. There are no risks, nor benefits for the participants.

Conditions

Colorectal Cancer; Polyps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients referred for colonoscopy

All patients referred for colonoscopy where invited to participate in our study.

Group Type: OTHER

AeonoseTM

Intervention Type: DEVICE

Breath test

Interventions

AeonoseTM

Breath test

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• Suspicion for (pre-)malignant lesions of the colon scheduled for colonoscopy

Exclusion Criteria

• Subjects with other known malignancies
• Subjects with established inflammatory bowel disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medisch spectrum Twente

Enschede, Twente, Netherlands

Countries

Netherlands

References

van Keulen KE, Jansen ME, Schrauwen RWM, Kolkman JJ, Siersema PD. Volatile organic compounds in breath can serve as a non-invasive diagnostic biomarker for the detection of advanced adenomas and colorectal cancer. Aliment Pharmacol Ther. 2020 Feb;51(3):334-346. doi: 10.1111/apt.15622. Epub 2019 Dec 20.

Reference Type: DERIVED

PMID: 31858615 (View on PubMed)

Other Identifiers

e-Nose and colorectal cancer

Identifier Type: -

Identifier Source: org_study_id