Barrett EsophagusELECTRONICNCT04656392
Early Detection of Barrett's Esophagus in Participants With Reflux Symptoms in Primary Care
A study testing Breath test (eNose) followed by uTNE. in people with Barrett Esophagus and Esophageal Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
In the Netherlands, the incidence of esophageal adenocarcinoma (EAC) is increasing. In addition, EAC has a dismal prognosis. Therefore, screening for Barrett's Esophagus (BE) has stimulated interest. Although BE is a known precursor of EAC, a minority of patients with EAC are known with a previous diagnosis of BE. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Barrett Esophagus, Esophageal Cancer
- What is being tested?
- Breath test (eNose) followed by uTNE.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Apr 2021to 11 Mar 2024
- 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
- Patient aged 50 to 75 years;
- Recorded diagnosis of reflux symptoms >90 days OR
- Recorded prescriptions for acid suppressant therapy for this indication for at least 1 year in the past 5 years
- Written informed consent.
Who cannot join
- Upper endoscopy in the previous 5 years;
- A current or previous diagnosis and/or treatment of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC)) within the last five years;
- Already known with a diagnosis of Barrett's esophagus or gastro-esophageal cancer;
- Any argument provided by a patient's own general practitioner not to include the patient;
- Comorbidities precluding transnasal endoscopy (e.g. inability to discontinue oral anticoagulants, history of recurrent epistaxis, allergy to lidocaine derivatives).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GA
About this study
Official title: Early Detection of Barrett's Esophagus and Esophageal Cancer: Accuracy and Acceptability of a Novel Screening Strategy in Primary Care
In the Netherlands, the incidence of esophageal adenocarcinoma (EAC) is increasing. In addition, EAC has a dismal prognosis. Therefore, screening for Barrett's Esophagus (BE) has stimulated interest. Although BE is a known precursor of EAC, a minority of patients with EAC are known with a previous diagnosis of BE. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.
Read the detailed description
The ongoing increasing incidence of esophageal adenocarcinoma (EAC) in the Netherlands during the last few decades and the still dismal prognosis has stimulated interest in screening for Barrett's esophagus (BE). Although BE is a known precursor of EAC, a minority of patients with EAC (<10%) are known with a previous diagnosis of BE, and hence, most cases of BE are undiagnosed. Screening programs to detect BE followed by endoscopic surveillance and treatment of dysplasia or early neoplasia seem able to reduce the incidence of EAC and improve survival. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. uTNE offers the possibility of a more acceptable and accurate endoscopic assessment of the esophagus with almost neglectable risks and lower costs compared to conventional endoscopy. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.
- Conditions
- Barrett Esophagus, Esophageal Cancer
- Being tested
- Breath test (eNose) followed by uTNE.
- Keywords
- Barrett Esophagus, Esophageal Cancer, Primary care, General practice, Screening
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath test (eNose) followed by uTNE.Diagnostic test
All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Breath test (eNose) followed by uTNE. | Other | All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital. Receives: Diagnostic Test: Breath test (eNose) followed by uTNE. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV) of the eNose for detecting confirmed BE
PPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
Measured: 16 weeks after breath test (eNose)
Negative Predictive Value (NPV) of the eNose for detecting confirmed BE
NPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
Measured: 16 weeks after breath test (eNose)
Sensitivity of the eNose for detecting confirmed BE
Sensitivity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
Measured: 16 weeks after breath test (eNose)
Specificity of the eNose for detecting confirmed BE
Specificity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
Measured: 16 weeks after breath test (eNose)
Secondary outcomes (13)
Patient acceptability (discomfort and overall experience) of the eNose measured on a NPRS.
Patient acceptability consists of two questions regarding discomfort and overall experience of the eNose. Discomfort is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'none' and 10 being 'severe'. Overall experience is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'the worst experience', 5 being 'neither pleasant nor unpleasant' and 10 being 'the best experience'.
Measured: Directly after breath test (eNose)
Patient acceptability (discomfort and overall experience) of uTNE measured on a NPRS.
Patient acceptability consists of two questions regarding discomfort and overall experience of uTNE. Discomfort is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'none' and 10 being 'severe'. Overall experience is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'the worst experience', 5 being 'neither pleasant nor unpleasant' and 10 being 'the best experience'.
Measured: Directly after uTNE
Patient acceptability (discomfort and overall experience) of conventional endoscopy (if applicable) measured on a NPRS.
Patient acceptability consists of two questions regarding discomfort and overall experience of conventional endoscopy. Discomfort is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'none' and 10 being 'severe'. Overall experience is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'the worst experience', 5 being 'neither pleasant nor unpleasant' and 10 being 'the best experience'.
Measured: Directly after conventional endoscopy
Willingness to undergo repeat eNose procedure
Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.
Measured: Directly after breath test (eNose)
Willingness to undergo repeat uTNE procedure
Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.
Measured: Directly after uTNE
Willingness to undergo repeat conventional endoscopy
Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.
Measured: Directly after conventional endoscopy
Cancer worry (CWS-8)
The Cancer Worry Scale (CWS-8) is used to measure cancer worry. Scores are ranging from 8 to 32, and higher scores indicate more cancer worry.
Measured: At baseline, 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure.
Anxiety (STAI-6)
The State-Trait Anxiety Inventory (STAI-6) is used to measure anxiety. Scores are ranging from 6 to 24, and higher scores indicate more anxiety.
Measured: At baseline, 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure.
Impact of event (IES-15)
The Impact of Event Scale (IES-15) is used to measure impact of event. Scores are ranging from 0 to 75, and higher scores indicate more impact of event.
Measured: 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure.
Rate of successful evaluation by uTNE
The rate of successful intubation and complete evaluation will be measured.
Measured: 1 week after the last participant undergoes uTNE.
Rate of successful evaluation by breath test (eNose)
The rate of successful intubation and complete evaluation will be measured.
Measured: 1 week after the last participant undergoes breath test (eNose).
Safety of uTNE based on reported Adverse Events.
The safety will be measured based on reported Adverse Events.
Measured: 1 week after the last participant undergoes uTNE.
Safety of eNose based on reported Adverse Events.
The safety will be measured based on reported Adverse Events.
Measured: 1 week after the last participant undergoes breath test (eNose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start20 Apr 2021
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies 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
- The study design is a multi-site prospective cohort study in eight general practices. All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.
- Masking
- None (open label)
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Digestive Diseases Foundation
- Responsible party
- Sponsor
- Investigators
- Peter D. Siersema, Prof.dr., Principal investigator, Radboud University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656392
- Sponsor's protocol ID
- 110769
- Acronym
- ELECTRONIC
- Status last verified
- Apr 2024
- First submitted
- 30 Nov 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Barrett's Esophagus and Esophageal Cancer: Accuracy and Acceptability of a Novel Screening Strategy in Primary Care
- ClinicalTrials.gov ID
- NCT04656392
- Acronym / sponsor ID
- ELECTRONIC / 110769
- Conditions
- Barrett Esophagus, Esophageal Cancer
- Keywords
- Barrett Esophagus, Esophageal Cancer, Primary care, General practice, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Digestive Diseases Foundation
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 7 Dec 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 Netherlands, the incidence of esophageal adenocarcinoma (EAC) is increasing. In addition, EAC has a dismal prognosis. Therefore, screening for Barrett's Esophagus (BE) has stimulated interest. Although BE is a known precursor of EAC, a minority of patients with EAC are known with a previous diagnosis of BE. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.
Detailed description
The ongoing increasing incidence of esophageal adenocarcinoma (EAC) in the Netherlands during the last few decades and the still dismal prognosis has stimulated interest in screening for Barrett's esophagus (BE). Although BE is a known precursor of EAC, a minority of patients with EAC (<10%) are known with a previous diagnosis of BE, and hence, most cases of BE are undiagnosed. Screening programs to detect BE followed by endoscopic surveillance and treatment of dysplasia or early neoplasia seem able to reduce the incidence of EAC and improve survival. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. uTNE offers the possibility of a more acceptable and accurate endoscopic assessment of the esophagus with almost neglectable risks and lower costs compared to conventional endoscopy. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study design is a multi-site prospective cohort study in eight general practices. All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.
| Arm | Type | Receives |
|---|---|---|
| Breath test (eNose) followed by uTNE. | Other | Diagnostic Test: Breath test (eNose) followed by uTNE.All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 50 to 75 years;
- Recorded diagnosis of reflux symptoms >90 days OR
- Recorded prescriptions for acid suppressant therapy for this indication for at least 1 year in the past 5 years
- Written informed consent.
Key exclusion criteria (5 listed)
- Upper endoscopy in the previous 5 years;
- A current or previous diagnosis and/or treatment of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC)) within the last five years;
- Already known with a diagnosis of Barrett's esophagus or gastro-esophageal cancer;
- Any argument provided by a patient's own general practitioner not to include the patient;
- Comorbidities precluding transnasal endoscopy (e.g. inability to discontinue oral anticoagulants, history of recurrent epistaxis, allergy to lidocaine derivatives).
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 |
|---|---|---|
| Breath test (eNose) followed by uTNE.All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital. | Diagnostic test | Breath test (eNose) followed by uTNE. |
Primary outcome
Positive Predictive Value (PPV) of the eNose for detecting confirmed BE
Time frame: 16 weeks after breath test (eNose)
PPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
Negative Predictive Value (NPV) of the eNose for detecting confirmed BE
Time frame: 16 weeks after breath test (eNose)
NPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
Sensitivity of the eNose for detecting confirmed BE
Time frame: 16 weeks after breath test (eNose)
Sensitivity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
Specificity of the eNose for detecting confirmed BE
Time frame: 16 weeks after breath test (eNose)
Specificity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
13 secondary outcomes
Patient acceptability (discomfort and overall experience) of the eNose measured on a NPRS.
Time frame: Directly after breath test (eNose)
Patient acceptability (discomfort and overall experience) of uTNE measured on a NPRS.
Time frame: Directly after uTNE
Patient acceptability (discomfort and overall experience) of conventional endoscopy (if applicable) measured on a NPRS.
Time frame: Directly after conventional endoscopy
Willingness to undergo repeat eNose procedure
Time frame: Directly after breath test (eNose)
Willingness to undergo repeat uTNE procedure
Time frame: Directly after uTNE
Willingness to undergo repeat conventional endoscopy
Time frame: Directly after conventional endoscopy
Cancer worry (CWS-8)
Time frame: At baseline, 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure.
Anxiety (STAI-6)
Time frame: At baseline, 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure.
Impact of event (IES-15)
Time frame: 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure.
Rate of successful evaluation by uTNE
Time frame: 1 week after the last participant undergoes uTNE.
Rate of successful evaluation by breath test (eNose)
Time frame: 1 week after the last participant undergoes breath test (eNose).
Safety of uTNE based on reported Adverse Events.
Time frame: 1 week after the last participant undergoes uTNE.
Safety of eNose based on reported Adverse Events.
Time frame: 1 week after the last participant undergoes breath test (eNose).
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 16 Apr 2024.
- Individual participant dataSharing planned: No
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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, Prof.dr. principal investigator
Radboud University Medical Center Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath test (eNose) followed by uTNE. in people with Barrett Esophagus and Esophageal Cancer, 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 4 inclusion and 5 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 16 Apr 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?
Positive Predictive Value (PPV) of the eNose for detecting confirmed BE (time frame: 16 weeks after breath test (eNose)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2024.