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 range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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