Non-endoscopic test to find Barrett's esophagus in veterans without chronic reflux.
Nonendoscopic Screening for Barrett's Esophagus and Esophageal Cancer in At-Risk Veterans Without History of Chronic Gastroesophageal Reflux
This project will test whether a simple, non-endoscopic swab-like test can find Barrett's esophagus in veterans over 40 who have risk factors for esophageal cancer but no chronic heartburn.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Louis Stokes VA Medical Center Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06746623 on ClinicalTrials.gov |
What this trial studies
The study offers an unsedated, non-endoscopic biomarker-based sampling procedure (Esocheck/Esoguard) in outpatient VA clinics to screen for Barrett's esophagus among veterans without chronic GERD. Enrolled participants who meet risk criteria will undergo the non-endoscopic test followed by diagnostic upper endoscopy to confirm findings. The team will measure screening acceptance, reasons for refusal, and the yield of positive detections compared with endoscopy. The aim is to see if adding this simple test increases detection of Barrett's esophagus and improves the positive predictive value of subsequent endoscopy in this population.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 40–84 who have no chronic GERD but have at least three risk factors for esophageal adenocarcinoma (for example male sex, obesity, significant smoking history, white race, or family history), have not had prior EGD, and meet safety criteria (no coagulopathy, no esophageal varices, not on chronic anticoagulation, and no severe swallowing problems).
Not a fit: Patients with chronic GERD (who already qualify for guideline-directed endoscopic screening), those on chronic anticoagulation or with known esophageal varices or significant dysphagia, and people outside the 40–84 age range are unlikely to gain benefit from this screening method.
Why it matters
Potential benefit: If successful, this approach could identify more cases of Barrett's esophagus earlier using a simple outpatient test, enabling earlier confirmatory endoscopy and follow-up.
How similar studies have performed: Similar non-endoscopic sampling devices and biomarker approaches (for example sponge or capsule-based tests like Cytosponge) have shown promise in detecting Barrett's esophagus in prior studies, so this work builds on existing positive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.
1. Adults \> 40 and \< 85 years old who have no prior EGD and can provide informed consent
2. Absence of chronic GERD symptoms (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
a. Meet ACG/AGA Clinical Guideline criteria for BE screening. Eligible subjects will have at least three additional risk factors for BE (white race, obesity defined as BMI \> 30, male gender, current smoker or smoking history \> 10 pack years, family history of Barrett's esophagus or EAC central obesity (waist size \> 35 inches for women and \> 40 inches for men), white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative).
3. No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
4. No significant dysphagia or odynophagia
Exclusion Criteria:
* Exclusion Criteria
1. History of prior EGD procedure in past ten years
2. Inability to provide written informed consent
3. History of weekly or more frequent heartburn or regurgitation for five or more years
4. On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5
5. Known history of esophageal varices or esophageal stricture
6. 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
7. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
8. Oropharyngeal tumor
9. History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET \<4%)
10. History of myocardial infarction or cerebrovascular accident within past 6 months
Where this trial is running
Cleveland, Ohio
- VA Northeast Ohio Healthcare System — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Katarina B Greer, MD/MS — Cleveland VA Research and Education Foundation
- Study coordinator: Katarina B. Greer, MD/MS
- Email: katarina.greer@va.gov
- Phone: 216-791-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.