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Completed

NCT Number: NCT04357158

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyp of Colon Polyps Rectal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud university medical center

Nijmegen, Gelderland, 6525GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Diagnostic accuracy in distinguishing colorectal carcinoma from healthy controls

    Time frame: 12 months

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

Secondary outcomes

  1. Diagnostic accuracy in distinguishing advanced adenoma from healthy controls

    Time frame: 12 months

    Sensitivity and specificity

  2. Reproducibility

    Time frame: 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)

  3. Acceptance rate

    Time frame: 12 months

    The acceptance rate of using the AeonoseTM in participating patients.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: SCREENER

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2020
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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