Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
Case Comprehensive Cancer Center
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.
Description
The overall goal of this clinical trial is to eliminate deaths from Esophageal Adenocarcinoma (EAC) by demonstrating the efficacy of a non-endoscopic method for efficient population screening to detect all Barrett's esophagus (BE), the precursor lesion of EAC. EAC is a highly lethal malignancy with less than 20% 5-year survival, and an annual U.S. incidence \> 14,000 that has increased more than 6-fold in the past three decades. Barrett's esophagus, a pre-malignant metaplasia/neoplasia, is the precursor lesion of EAC, but is currently detectable only when patients undergo upper endoscopy (EGD)…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 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 coag…
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 ColoradoAurora, Colorado
- Johns Hopkins HospitalBaltimore, Maryland
- University of North Carolina at Chapel HillChapel Hill, North Carolina
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- Cleveland Clinic Taussig Cancer CenterCleveland, Ohio