RecruitingNot ApplicableNCT06687603

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


Sponsor

Case Comprehensive Cancer Center

Enrollment

800 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a non-invasive capsule-based screening method can detect Barrett's esophagus — a pre-cancerous condition of the esophagus — in people who don't have typical heartburn symptoms but are at elevated risk. **You may be eligible if...** - You are 50 years or older - You do not have regular heartburn or reflux symptoms and are not on heartburn medications - You have at least 2 additional risk factors for Barrett's esophagus: abdominal obesity, a significant smoking history, being white, being male, or having a family history of Barrett's esophagus or esophageal cancer - You are scheduled for a routine colonoscopy - You have not had an upper endoscopy (a camera down the throat) in the past 10 years - You do not take blood thinners that cannot be stopped temporarily **You may NOT be eligible if...** - You have had an upper endoscopy in the past 10 years - You have known esophageal varices, strictures, or a history of esophageal/stomach surgery - You have difficulty or pain swallowing - You are on anticoagulants that cannot be paused - You have weekly or more frequent heartburn symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEsoCheck

FDA-approved, non-endoscopic, encapsulated swallowable balloon. EsoCheck will produce a sample which will subsequently be tested with EsoGuard assay. The EsoCheck is performed and completed in approximately 5 minutes.

DIAGNOSTIC_TESTEsoGuard

Approved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants.


Locations(5)

University of Colorado

Aurora, Colorado, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06687603


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