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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
VA Northeast Ohio Healthcare System
RECRUITING
Cleveland
Contact Information
Primary
Katarina B. Greer, MD/MS
katarina.greer@va.gov
216-791-3800
Backup
Lauren H. Hricik, BA
lauren.hricik@va.gov
(216) 791-3800
Time Frame
Start Date: 2025-04-11
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 400
Treatments
Other: This is a single arm study. Participants will complete 2 diagnostic tests: Esocheck and EGD.
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.
Sponsors
Collaborators: United States Department of Defense
Leads: Louis Stokes VA Medical Center

This content was sourced from clinicaltrials.gov