Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux (NCT06746623) | Clinical Trial Compass
RecruitingNot Applicable
Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux
United States400 participantsStarted 2025-04-11
Plain-language summary
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.
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. Adults \> 40 and \< 85 years old who have no prior EGD and can provide informed consent
✓. Absence of chronic GERD symptoms (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
✓. No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
✓. No significant dysphagia or odynophagia
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
✕. On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5
✕. Known history of esophageal varices or esophageal stricture
✕
What they're measuring
1
Esoguard assay and histology confirming diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma
Timeframe: Laboratory and pathology results will be finalized within 10 and up to 30 days
. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
✕. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills