Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. The main question it aims to answer is: Can this approach demonstrate efficacy for screening of Barrett's esophagus? Participants will: * Participate in a questionnaire. * Undergo a capsule balloon test, called EsoCheck. * Have their EsoCheck sample sent to the laboratory for an EsoGuard test, which is used to detect Barrett's esophagus. * Participants will undergo upper endoscopy as part of standard of care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

⁃ Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be:

• Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:

• No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:

• No significant dysphagia or odynophagia; but who do have:

• Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:

• Adults \> age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size \> 35 inches for women and \> 40 inches for men), current smoker or smoking history \> 10 pack years, white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria.

• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Locations
United States
Colorado
University of Colorado
NOT_YET_RECRUITING
Aurora
Maryland
Johns Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
North Carolina
University of North Carolina at Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
Ohio
Cleveland Clinic Taussig Cancer Center
NOT_YET_RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Contact Information
Primary
Wendy Brock
Wendy.brock@uhhospitals.org
216-844-3853
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2029-09-27
Participants
Target number of participants: 800
Treatments
Experimental: EsoCheck + EsoGuard
Participants will undergo an EsoCheck test. The sample produced by the EsoCheck will be sent to LucidDx where the EsoGuard assay will be performed.
Sponsors
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov

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