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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04357158

Collaborator

(none)

750

Enrollment

Location

Arm

21.2

Anticipated Duration (Months)

35.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Polyp of Colon Colorectal Neoplasms	Device: AeonoseTM	N/A

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 if the use of an additional breath test (AeonoseTM) for patients with a positive FIT-test can reduce the number of unnecessary colonoscopies.

Secondary objectives:

External validation of results for CRC and (advanced) adenoma detection established in a previous studies (second study not yet published). (15)
To evaluate if VOC profiles in breath are similar at two different time points.
Acceptance rate of using the AeonoseTM device for VOC analysis in participating patients.

Study population: Patients between the ages of 55 and 75 years old with a positive FIT-test referred for a colonoscopy procedure.

Estimated sample size: 750 participants

Intervention: Participants will be asked to breath through the AeonoseTM for 5 minutes during pre-colonoscopy intake and just prior to the procedure to assess reproducibility (with >2 weeks in between). There are no risks, nor benefits for the participants.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Breath analysiS as an Additional Test for ColoREctal cancEr screeNing to rEduce the Number of unnecessaRy Colonoscopies

Actual Study Start Date :

May 25, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients referred for colonoscopy	Device: AeonoseTM 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).

Arm

Intervention/Treatment

Other: Patients referred for colonoscopy

Device: AeonoseTM

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).

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy in distinguishing colorectal carcinoma from healthy controls [12 months]
The diagnostic accuracy, in terms of sensitivity and specificity, of the AeonoseTM in distinguishing between patients with and without CRC.

Secondary Outcome Measures

Diagnostic accuracy in distinguishing advanced adenoma from healthy controls [12 months]
Sensitivity and specificity
Reproducibility [12 months]
The variation in VOC analysis results between two separate time points. The binary results from the eNose analysis will be presented in a scatterplot and a receiver operating characteristics curve (ROC-curve). Cohen's kappa statistic will be applied to determine interobserver agreement between the eNose results of 2 different timepoints (>2 weeks apart)
Acceptance rate [12 months]
The acceptance rate of using the AeonoseTM in participating patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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