Nonendoscopic Screening for Barrett's Esophagus and Esophageal Cancer in At-Risk Veterans Without History of Chronic Gastroesophageal Reflux

What this Trial Is About

This research focuses on veterans at higher risk for esophageal adenocarcinoma (EAC) and its precursor, Barrett's esophagus (BE), due to factors like age, gender, obesity, smoking, and family history. Current guidelines recommend screening only for those with reflux symptoms, but many patients who develop EAC do not report such symptoms. This study evaluates a non-endoscopic screening method to detect BE in veterans without chronic reflux but with multiple risk factors, aiming to improve detection rates and reduce the need for costly endoscopy. Participants will undergo a non-endoscopic test called Esocheck, which collects esophageal tissue samples analyzed by the Esoguard assay for specific biomarkers linked to BE. Those eligible have no history of GERD and have at least three risk factors such as white race, male gender, obesity, smoking history, or family history of BE or EAC. After the Esocheck test, all participants will be offered a standard upper endoscopy (EGD) on the same day to confirm findings and provide diagnostic comparison. During the study, participants will provide informed consent and complete both the Esocheck screening and upper endoscopy. Researchers will analyze tissue samples for biomarker presence and compare results with endoscopy findings to assess sensitivity and specificity. They will also track acceptance rates and reasons for refusing screening. The primary outcome is the confirmation of BE or EAC diagnosis within 10 to 30 days. The study plans to enroll 400 veterans aged 40 to 85 without prior endoscopy and monitor results to improve future screening recommendations.

Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux