Actively Recruiting
Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
Led by Case Comprehensive Cancer Center · Updated on 2025-11-13
800
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new non-endoscopic method to detect Barrett's esophagus in people without chronic GERD symptoms. Barrett's esophagus is a condition where the lining of the esophagus is damaged by acid reflux and can lead to esophageal adenocarcinoma, a deadly cancer. The study aims to see if this new office-based test can effectively screen for Barrett's esophagus in high-risk individuals who do not have symptoms of GERD, expanding detection beyond current guidelines. Participants will undergo the EsoCheck test, which involves swallowing a small encapsulated balloon device that collects esophageal cells within about 5 minutes. The collected sample is then sent to a laboratory for the EsoGuard assay, a methylated DNA panel that detects Barrett's esophagus. This approach is designed to offer a quick, non-invasive screening alternative to upper endoscopy. Participants will also undergo standard upper endoscopy as part of usual care. During the study, participants will complete a questionnaire and provide samples via the EsoCheck device. Researchers will assess the accuracy of the EsoCheck/EsoGuard testing by measuring the positive predictive value for Barrett's esophagus and analyzing the prevalence of Barrett's in test-negative subjects. The study will monitor participants for up to 5 years to understand the test's effectiveness and tissue origins of true versus false positives. Participant involvement includes sample collection, endoscopy, and follow-up assessments throughout the study duration.
CONDITIONS
Brief Title
Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 years or older
- No prior upper endoscopy (EGD) within the past 10 years
- No symptoms of GERD such as weekly heartburn or regurgitation
- Not currently on medications for GERD
- No known bleeding disorders or esophageal varices
- No chronic anticoagulation therapy
- No significant difficulty or pain swallowing
- At least two risk factors for Barrett's esophagus such as central obesity, smoking history (>10 pack years), white race, male sex, or family history of Barrett's esophagus or esophageal adenocarcinoma
- Ability and willingness to provide informed consent
You will not qualify if you...
- Prior upper endoscopy procedure within the past 10 years
- Inability to provide written informed consent
- History of weekly or more frequent heartburn or acid regurgitation for 5 or more years
- Use of anticoagulant drugs that cannot be temporarily stopped or coagulopathy with INR > 1.5
- Known esophageal varices or esophageal stricture
- Medical conditions that contraindicate the EsoCheck procedure, endoscopy, or biopsies, including coagulopathy, esophageal diverticula, fistula, or ulceration
- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including difficulty swallowing pills
- Presence of oropharyngeal tumor
- History of esophageal or gastric surgery, except uncomplicated surgical fundoplication procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure completed in approximately 5 minutes
Participants undergo the EsoCheck test, a non-endoscopic procedure that collects esophageal samples using a swallowable balloon. The samples are then tested with the EsoGuard assay to detect Barrett's esophagus.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored over time to assess outcomes related to Barrett's Esophagus detection and prevalence.
Follow-up visits as scheduled per study protocol
Trial Site Locations
Total: 5 locations
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
3
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 027599
Actively Recruiting
4
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44016
Actively Recruiting
5
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
Research Team
W
Wendy Brock
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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