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Early Detection of Barrett's Esophagus in Participants With Reflux Symptoms in Primary Care

NCT04656392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2024-04-16

No results posted yet for this study

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. 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

  • Barrett Esophagus
  • Esophageal Cancer

Interventions

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.

Sponsors & Collaborators

  • Dutch Digestive Diseases Foundation

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Peter D. Siersema, Prof.dr. · Radboud University Medical Center Nijmegen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2024-03-11
Completion
2024-03-11

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04656392 on ClinicalTrials.gov