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.
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). Despite Guideline recommendations for EGD in chronic GERD (gastrointestinal reflux disease) patients, barriers to EGD that include cost, sedation, and lack of acceptance, have so severely limited screening that antecedent BE remains undetected in over 95% of EAC cases. A major advance in EAC prevention was made by developing a non- endoscopic biomarker based method for detecting BE. The technology consists of an encapsulated swallowable balloon (EsoCheck) enabling a 5 minute non-endoscopic sampling of the esophagus, combined with a methylated DNA panel that detects esophageal neoplasia (EsoGuard). The research team validated the \> 90% sensitivity and specificity of EC+EG testing in the population of individuals who have symptomatic GERD, and who account for 60% of EAC cases. In this new proposal, the research team plans to double the impact of this technology to detect nearly all individuals harboring BE, by proving the EC+EG technology is so robust that it further enables screening a population of high risk, but asymptomatic, non-GERD individuals who account for the remaining 40% of EAC cases, but who fall totally outside of all current screening guidelines.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
800
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.
Approved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants.
University of Colorado
Aurora, Colorado, United States
RECRUITINGJohns Hopkins Hospital
Baltimore, Maryland, United States
NOT_YET_RECRUITINGUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGCleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
NOT_YET_RECRUITINGPositive 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 years
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 years
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 years
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