e-Nose and Colorectal Cancer

Not Applicable

Completed

• Conditions: Colorectal Cancer; Polyps
• Interventions: Device: AeonoseTM

• Registration Number: NCT03488537
• Lead Sponsor: Radboud University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-02
• Study Start: 2018-02-28
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-28
• Study First Posted: 2018-04-05
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients referred for colonoscopy	AeonoseTM	All patients referred for colonoscopy where invited to participate in our study.

Primary Outcome Measures

Name	Time	Method
sensitivity/specificity for CRC	38 weeks	Diagnostic accuracy of the Aeonose to detect CRC in terms of sensitivity and specificity

Secondary Outcome Measures

Name	Time	Method
sensitivity/specificity for advanced adenomas and/or sessile serrated lesions.	38 weeks	Diagnostic accuracy of the Aeonose to detect polyps in terms of sensitivity and specificity
Sensitivity/specificity for detection of CRC and/or polyps before and after bowel preparation	38 weeks	Diagnostic accuracy, sensitivity/specificity/AUC

Trial Locations

Locations (1)

Medisch spectrum Twente; 🇳🇱 Enschede, Twente, Netherlands