No registrations found.
ID
Source
Brief title
Health condition
Barrett's esophagus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity and specificity of the eNose for detecting BE with the diagnosis made by upper endoscopy as the reference standard.
Secondary outcome
- Acceptance rates for breath testing
- Patient acceptability of the eNose procedure
- Technical or patient related problems obtaining a read-out from the Aeonose™
- Accuracy of the eNose with which it could distinguish patients with BE from patients with GERD
- Reproducibility by repeated testing
- Effect of PPI use on the accuracy of the eNose for detecting BE
Background summary
Primary objective: To determine the diagnostic accuracy of exhaled breath analysis with the Aeonose to discriminate between patients with Barrett’s esophagus versus patients without a diagnosis of Barrett’s esophagus.
Study design: The present multicenter case-control study will include 980 patients who are undergoing a clinically indicated (surveillance) upper endoscopy. First a database of breath prints will be developed to detect BE. In this study phase the Aeonose™ will be trained and the database of breath prints will be verified using “leave 10% out” cross validation. After the calibration phase the diagnostic accuracy of Aeonose™ will be assessed in new study patients (external validation).
Study population: Patients who are planned to undergo a endoscopy will be asked to participate in this study. Subjects will be divided into 3 groups based on current diagnosis: (1) patients with known BE, (2) patients with reflux symptoms and (3) healthy individuals without reflux symptoms.
Main study parameters/ endpoints: The primary outcome of the study is sensitivity and specificity of the eNose for detecting BE with the diagnosis made by upper endoscopy as the reference standard. Secondary study endpoints are acceptance rates for breath testing, technical or patient related problems obtaining a read-out from the Aeonose™, accuracy of the eNose with which it could distinguish patients with BE from patients with GERD, reproducibility by repeated testing, effect of PPI use on the accuracy of the eNose for detecting BE.
Study objective
the Aeonose is able to discriminate between patients with Barrett’s esophagus versus patients without a diagnosis of Barrett’s esophagus.
Study design
NA
Inclusion criteria
- Aged 18 years or older
- Undergoing a clinically indicated (surveillance) endoscopy
- Able to give signed informed consent
1. Patients with known BE (defined as ≥1 cm of columnar mucosa with histopathologic confirmation of intestinal metaplasia without dysplasia)
2. Individuals with GERD symptoms without BE (GERDQ-score ≥8 or the endoscopic presence of reflux esophagitis)
3. ‘Healthy’ controls without BE or GERD
Exclusion criteria
- Patients with a history of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC))
- Prior surgical esophageal or gastric resection or prior ablative therapy
- Patients who are unable to perform breathing maneuver needed for Aeonose-analysis of exhaled breath
Withdrawal criteria after initial study inclusion:
Patients can be withdrawn from the study if:
- Incomplete upper endoscopy
- Active H. Pylori infection
- BE segment <1cm or no intestinal metaplasia in the esophagus
- Intestinal metaplasia in the stomach
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8083 |
| Other | CMO regio Arnhem-Nijmegen / Lokale CMO Radboudumc : 2019-5677 |