Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorLouis Stokes VA Medical Center

About this trial

The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors compared to the general population. BE is traditionally diagnosed only when patients undergo endoscopy with biopsies. However, due to the high cost of endoscopy and the lack of studies proving efficacy of screening, endoscopy to screen for BE is not routinely recommended. A simpler screening procedure similar to a pap smear would be an ideal way to sample the esophageal tissue for cancer and its precursor condition, BE. This study proposes a non-endoscopic detection method administered in outpatient offices which would increase subsequent endoscopic detection of BE. The study team will be enrolling veterans who do not have history of gastroesophageal reflux but have multiple risk factors for esophageal adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.

Adults > 40 and < 85 years old who have no prior EGD and can provide informed consent

No significant dysphagia or odynophagia

Disqualifiers

Exclusion Criteria

History of prior EGD procedure in past ten years

Inability to provide written informed consent

History of weekly or more frequent heartburn or regurgitation for five or more years

Trial design

Design model

Single group

Treatments tested in this trial

  • Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy.

    Diagnostic test

    Esocheck (EC)/Esoguard (EG): EC is a encapsulated balloon device available commercially from Lucid Diagnostics (New York, NY). EG assay uses bisulfite sequencing for detection of aberrant methylation in the vimentin and cyclin A1 genomic loci, respectively. EGD (upper endoscopy): EGD will be performed by gastroenterologists practicing in the Louis Stokes Cleveland VA Medical Center Endoscopy laboratories on the same day when EC/EG is performed.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: This is a single arm study. Participants will complete 2 diagnostic tests: Esocheck and EGD.Other 1 intervention

Trial outcomes

Primary outcomes

1

Esoguard assay and histology confirming diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma

Results from enrollment visit

Time frame
Laboratory and pathology results will be finalized within 10 and up to 30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Louis Stokes VA Medical Center

Lead sponsor

United States Department of Defense

Collaborator