RecruitingNot ApplicableNCT06746623

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


Sponsor

Louis Stokes VA Medical Center

Enrollment

400 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a non-endoscopic device called EsoCheck (a small pill-sized capsule that collects esophageal cells without a full scope procedure) to screen for Barrett's esophagus — a condition where stomach acid damages the esophagus lining and can lead to esophageal cancer — in veterans who don't have classic heartburn symptoms but have other risk factors. **You may be eligible if...** - You are between 40 and 85 years old - You have never had an upper endoscopy (scope of the esophagus/stomach) - You do NOT have chronic heartburn or reflux - You have at least 3 risk factors for Barrett's esophagus, such as: being male, white race, obesity (BMI > 30), smoking history, or a family history of Barrett's or esophageal cancer - You have no significant swallowing problems or blood-clotting issues **You may NOT be eligible if...** - You have had an upper endoscopy in the past 10 years - You have weekly heartburn or reflux symptoms lasting 5+ years - You are on blood thinners that cannot be safely stopped - You have known esophageal varices, stricture, or a history of esophageal/gastric surgery - You have had a heart attack or stroke in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTEnrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy.

Esocheck (EC)/Esoguard (EG): EC is a encapsulated balloon device available commercially from Lucid Diagnostics (New York, NY). EG assay uses bisulfite sequencing for detection of aberrant methylation in the vimentin and cyclin A1 genomic loci, respectively. EGD (upper endoscopy): EGD will be performed by gastroenterologists practicing in the Louis Stokes Cleveland VA Medical Center Endoscopy laboratories on the same day when EC/EG is performed.


Locations(1)

VA Northeast Ohio Healthcare System

Cleveland, Ohio, United States

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NCT06746623


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