Clinical trial · Interventional
Early Detection of Barrett's Esophagus in Participants With Reflux Symptoms in Primary Care
Early Detection of Barrett's Esophagus and Esophageal Cancer: Accuracy and Acceptability of a Novel Screening Strategy in Primary Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breath test (eNose) followed by uTNE. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Breath test (eNose) followed by uTNE.
- description
- All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.
- interventionNames
- Diagnostic Test: Breath test (eNose) followed by uTNE.
Primary outcomes (4)
- measure
- Positive Predictive Value (PPV) of the eNose for detecting confirmed BE
- timeFrame
- 16 weeks after breath test (eNose)
- description
- 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.
- measure
- Negative Predictive Value (NPV) of the eNose for detecting confirmed BE
- timeFrame
- 16 weeks after breath test (eNose)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
References
Publications (0)
Data not yet available