Clinical trial · Interventional
Nonendoscopic Screening for 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Family History of Esophageal Cancer | — | UNRESOLVED | — |
| Obese Patients | — | UNRESOLVED | — |
| Tobacco Use | — | UNRESOLVED | — |
| Veterans | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- This is a single arm study. Participants will complete 2 diagnostic tests: Esocheck and EGD.
- description
- Patients without history of GERD receiving care in Wade Park VA will be approached regarding BE screening. Reasons for refusal of screening will be recorded. Adult subjects without history of gastroesophageal reflux with three or more risk factors- white race, male gender, obesity (BMI \> 30), smoking, or family history will be included. Only those patients who have not had prior EGD will be candidates for Esocheck screening. Distal esophageal samples will be assayed for mVIM + mCCNA1 (Esoguard assay). All patients will be offered upper endoscopy.
- interventionNames
- Diagnostic Test: Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy.
Primary outcomes (1)
- measure
- 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
- description
- Results from enrollment visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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 monthsReferences
Publications (1)
- BACKGROUNDGreer KB, Blum AE, Faulx AL, Deming EM, Hricik LL, Siddiqui H, Wilson BM, Chak A. Nonendoscopic Screening for Barrett's Esophagus and Esophageal Adenocarcinoma in At-Risk Veterans. Am J Gastroenterol. 2025 Mar 1;120(3):545-553. doi: 10.14309/ajg.0000000000002962. Epub 2024 Jul 11. PMID 38989889