Early detection of Barrett's esophagus and esophageal cancer: accuracy and acceptability of a novel screening strategy in primary care.

Completed

• Conditions: Barrett's esophagus; esophageal adenocarcinoma; Esophageal cancer; 10017990

• Registration Number: NL-OMON49567
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 450

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 of any type of malignancy (not including
basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC));
- Already known with a diagnosis of Barrett*s esophagus;
- 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).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter / endpoint: accuracy (PPV, NPV, sensitivity, and<br /><br>specificity) of the eNose for detecting confirmed BE with the diagnosis made by<br /><br>transnasal endoscopy and upper endoscopy as the reference standard in primary<br /><br>care.<br /><br><br /><br>Gold standard: transnasal endoscopy and upper endoscopy.</p><br>