The purpose of this study is to determine whether the EnteroTracker can obtain biomarkers that have been studied to be significant in screening BE and EAC. The current standard of care is endoscopic biopsy where the pathologist will visualize the tissue under a microscope to interpret diagnosis. Another goal of this study is to understand tolerance of the procedure so it might be used in an at-home setting.
This study seeks to determine the ability of a minimally invasive capsule-string device, the EnteroTracker®, to capture biomarkers associated with Barrett's Esophagus (BE) and Esophageal Adenocarcinoma (EAC). Identification of biomarkers in samples will support development of this simple-to-use, scalable, method for early screening of EAC, a cancer that accounts for the majority of esophageal cancers in the United States. In this study, the investigators plan to capture esophageal luminal content using the EnteroTracker® from patients with confirmed BE and/or EAC (test group) and healthy adults (control group). Samples will then be analyzed for series of biomarkers associated with BE and/or EAC. The investigators will test the hypothesis that the EnteroTracker® is able to capture biomarkers of interest in subjects with BE and EAC compared to healthy controls. To address this hypothesis, the investigators propose a pilot study with the following two specific aims. Evaluate the ability and tolerability of the EnteroTracker® to capture esophageal mucosal samples in adults with BE and/or EAC as well as controls and determine the ability of the EnteroTracker®-obtained BE/EAC biomarkers to distinguish between BE and/or EAC from control subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
The EnteroTracker® is a capsule device that includes an absorbent string.
University of Colorado
Aurora, Colorado, United States
Study Esophageal Mucosal Samples using Enterotracker Device
Capture esophageal mucosal samples in at least 50% of the test subjects using the EnteroTracker®.
Time frame: 2 years
Testing Tolerability via "Post-Procedure Tolerability Survey"
At least 50% of subjects describe the EnteroTracker® as "Satisfactory" from taking a "Post-Procedure Tolerability Survey".
Time frame: 2 years
Testing difference in Biomarkers between Control and BE/EAC patients
At least one biomarker differentiated between BE/EAC patients and control subjects in at least 50% of test subjects. Samples will be analyzed for various biomarkers including proteins, DNA, RNA and/or methylation of DNA.
Time frame: 2 years
Studying DNA Collection using Enterotracker Device
Capture at least 1 µg of DNA from the EnteroTracker® obtained mucosal samples in at least 50% of the test subjects.
Time frame: 2 years
Testing Symptoms via Follow Up Adverse Event assessment call
No more than 50% of subjects experienced more than one of the following side effects: nausea, choking, sore throat, vomiting, or chest pain.
Time frame: 2 years
Testing difference in Multiple Biomarkers between Control and BE/EAC patients
More than one biomarker differentiated between BE/EAC patients and control subjects in at least 50% of test subjects. Samples will be analyzed for various biomarkers including proteins, DNA, RNA and/or methylation of DNA.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.