e-Nose and Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Detection of Colorectal Cancer From Exhaled Air. Part II: Validation

Conditions
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Colorectal Cancer, Polyps

Intervention / Treatment
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* Device: AeonoseTM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a Multi center prospective cohort study in subjects eligible for colonoscopy with suspicion for malignant or premalignant lesions of the colon.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients referred for colonoscopy<br>All patients referred for colonoscopy where invited to participate in our study. | Device: AeonoseTM<br>* Breath test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity/specificity for CRC | Diagnostic accuracy of the Aeonose to detect CRC in terms of sensitivity and specificity | 38 weeks | 

Secondary Outcome Measures

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