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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy.
Diagnostic testEsocheck (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
Trial outcomes
Primary outcomes
Esoguard assay and histology confirming diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma
Results from enrollment visit
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