Breath Analysis as an Additional Test for Colorectal Cancer Screening to Reduce the Number of Unnecessary Colonoscopies
Condition: Colorectal Cancer; Polyp of Colon; Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms; Colonic Polyps
Study type: Interventional

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.
    

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:

        1. External validation of results for CRC and (advanced) adenoma detection established in a
           previous studies (second study not yet published). (15)

        2. To evaluate if VOC profiles in breath are similar at two different time points.

        3. 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.
    

Intervention name(s): AeonoseTM
Intervention type(s): Device
Intervention description(s): 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).
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 colon
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Volatile organic compounds; VOC; Colorectal cancer; Advanced adenoma; Breath test; Electronic nose; eNose; Aeonose