Actively Recruiting
Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux
Led by Louis Stokes VA Medical Center · Updated on 2025-06-05
400
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
Sponsors
L
Louis Stokes VA Medical Center
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 40 and under 85 years old who have not had an upper endoscopy before and can give informed consent
- No history of chronic GERD symptoms such as weekly heartburn or regurgitation and not taking GERD medications
- At least three risk factors including white race, obesity (BMI over 30), male gender, current or significant past smoking, family history of Barrett's esophagus or esophageal cancer, or central obesity (waist size over 35 inches for women and over 40 inches for men)
- No known bleeding problems, esophageal varices, or use of chronic anticoagulation therapy
- No significant difficulty or pain swallowing
You will not qualify if you...
- Previous upper endoscopy within the past ten years
- Unable to provide written informed consent
- History of weekly or more frequent heartburn or regurgitation for five or more years
- On anticoagulant drugs that cannot be stopped temporarily or have coagulopathy with INR over 1.5
- Known esophageal varices or esophageal narrowing
- Any medical reason that makes the EsoCheck or endoscopy procedure unsafe, including certain esophageal conditions
- History of difficulty swallowing or painful swallowing, including swallowing pills
- Presence of oropharyngeal tumor
- History of esophageal or stomach surgery except for uncomplicated recent surgical fundoplication with normal acid exposure
- Heart attack or stroke within the past six months
AI-Screening
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Trial Site Locations
Total: 1 location
1
VA Northeast Ohio Healthcare System
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
K
Katarina B. Greer, MD/MS
CONTACT
L
Lauren H. Hricik, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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