Colorectal CancerSCREENERNCT04357158
Breath Analysis as an Additional Test for Colorectal Cancer Screening to Reduce the Number of Unnecessary Colonoscopies
A study testing AeonoseTM in people with Colorectal Cancer and Polyp of Colon, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer, Polyp of Colon, Colorectal Neoplasms
- What is being tested?
- AeonoseTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 May 2020to 5 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525GA
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, Polyp of Colon, Colorectal Neoplasms
- Being tested
- AeonoseTM
- Keywords
- Volatile organic compounds, VOC, Colorectal cancer, Advanced adenoma, Breath test, Electronic nose, eNose, Aeonose
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeonoseTMDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for colonoscopy | Other | Not described Receives: Device: AeonoseTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy in distinguishing colorectal carcinoma from healthy controls
The diagnostic accuracy, in terms of sensitivity and specificity, of the AeonoseTM in distinguishing between patients with and without CRC.
Measured: 12 months
Secondary outcomes (3)
Diagnostic accuracy in distinguishing advanced adenoma from healthy controls
Sensitivity and specificity
Measured: 12 months
Reproducibility
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)
Measured: 12 months
Acceptance rate
The acceptance rate of using the AeonoseTM in participating patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start25 May 2020
- Primary completion5 Jan 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter D Siersema, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357158
- Sponsor's protocol ID
- '2020-6184'
- Acronym
- SCREENER
- Status last verified
- Sep 2021
- First submitted
- 20 Apr 2020
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Riswijk MLM, van Keulen KE, Tan ACITL, Schrauwen RWM, de Vos Tot Nederveen Cappel WH, Siersema PD; eNose CRC study group. Research Communication: Breath Testing for Colorectal Cancer Detection in Patients With a Positive Fecal Immunochemical Test: A Multicentre Prospective Cross-Sectional Study With External Validation. Aliment Pharmacol Ther. 2025 Jul;62(2):208-213. doi: 10.1111/apt.70207. Epub 2025 Jun 3.
PubMed 40459533van Riswijk MLM, van Tintelen BFM, Lucas RH, van der Palen J, Siersema PD. Overcoming methodological barriers in electronic nose clinical studies, a simulation data-based approach. J Breath Res. 2025 May 9;19(3). doi: 10.1088/1752-7163/add291.
PubMed 40306296
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath analysiS as an Additional Test for ColoREctal cancEr screeNing to rEduce the Number of unnecessaRy Colonoscopies
- ClinicalTrials.gov ID
- NCT04357158
- Acronym / sponsor ID
- SCREENER / '2020-6184'
- Conditions
- Colorectal Cancer, Polyp of Colon, Colorectal Neoplasms
- Keywords
- Volatile organic compounds, VOC, Colorectal cancer, Advanced adenoma, Breath test, Electronic nose, eNose, Aeonose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multicenter prospective cohort study in participants eligible for colonoscopy with suspicion for (pre)malignant lesions of the colon
| Arm | Type | Receives |
|---|---|---|
| Patients referred for colonoscopy | Other | Device: AeonoseTM |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AeonoseTMAll 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). | Device | Patients referred for colonoscopy |
Primary outcome
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.
3 secondary outcomes
Diagnostic accuracy in distinguishing advanced adenoma from healthy controls
Time frame: 12 months
Reproducibility
Time frame: 12 months
Acceptance rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 40459533van Riswijk MLM, van Keulen KE, Tan ACITL, Schrauwen RWM, de Vos Tot Nederveen Cappel WH, Siersema PD; eNose CRC study group. Research Communication: Breath Testing for Colorectal Cancer Detection in Patients With a Positive Fecal Immunochemical Test: A Multicentre Prospective Cross-Sectional Study With External Validation. Aliment Pharmacol Ther. 2025 Jul;62(2):208-213. doi: 10.1111/apt.70207. Epub 2025 Jun 3.
- Derived from this study: PubMed 40306296van Riswijk MLM, van Tintelen BFM, Lucas RH, van der Palen J, Siersema PD. Overcoming methodological barriers in electronic nose clinical studies, a simulation data-based approach. J Breath Res. 2025 May 9;19(3). doi: 10.1088/1752-7163/add291.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter D Siersema, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AeonoseTM in people with Colorectal Cancer and Polyp of Colon, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy in distinguishing colorectal carcinoma from healthy controls (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04357158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.