Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCase Comprehensive Cancer Center
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Disqualifiers
History of prior EGD procedure in past ten years
Inability to provide written informed consent
History of weekly of more frequent heartburn or regurgitation for five or more years
On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR > 1.5
Trial design
Design model
Single group
Treatments tested in this trial
EsoCheck
DeviceFDA-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.
EsoGuard
Diagnostic testApproved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants.
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: EsoCheck + EsoGuardExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Positive predictive value for Barret's Esophagus in EsoCheck/EsoGuard positive participants
The primary goal of this study is to develop a non-endoscopic screening test for the non-GERD population that provides a PPV \>20%, i.e. at least 2-fold greater than the 10% PPV of society recommended EGD screening of chronic GERD patients with any additional risk factors.
Time frame
Up to 5 years2
Barrett's Esophagus prevalence in EsoCheck/EsoGuard test negative subjects from a high-risk GERD negative population
This study will also perform endoscopy in a sample of EC/EG negative subjects to confirm that BE is enriched in the test positive versus test negative population. This will be measured by the prevalence of BE in a high-risk GERD negative population.
Time frame
Up to 5 years3
Tissue origins of true positive versus false positive EsoCheck/EsoGuard tests in non-GERD screening population
In BE positive cases, biopsies will be taken every 2-cm across the BE segment to map the extent of the field of methylated Vimentin (mVim) and methylated CCNA1 (mCCNA1) DNA detected by EsoGuard.
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov