Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06746623

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

Sponsor: Louis Stokes VA Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-04-11

Completion Date

2028-12-31

Last Updated

2025-06-05

Healthy Volunteers

Conditions

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

Interventions

DIAGNOSTIC_TEST

Enrolled 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.

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

Locations (1)

VA Northeast Ohio Healthcare System

Cleveland, Ohio, United States