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

Barrett Esophagus Obese Patients Tobacco Use Veterans Family History of Esophageal Cancer

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

Inclusion Criteria6

Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.
Adults \> 40 and \< 85 years old who have no prior EGD and can provide informed consent
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).
No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
No significant dysphagia or odynophagia

Exclusion Criteria10

History of prior EGD procedure in past ten years
Inability to provide written informed consent
History of weekly or more frequent heartburn or regurgitation for five or more years
On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5
Known history of esophageal varices or esophageal stricture
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
History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
Oropharyngeal tumor
History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET \<4%)
History of myocardial infarction or cerebrovascular accident within past 6 months

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.