Study to Evaluate EnteroTracker® as a Sampling Method to Screen for Barrett's Esophagus/Esophageal Cancer

Launched by UNIVERSITY OF COLORADO, DENVER · Jan 20, 2023

Keywords

ClinConnect Summary

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 ad...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Provision to sign and date the consent form.
• • 2. Stated willingness to comply with all study procedures and be available for the duration of the study.
• • 3. Be a male or female aged 45 years or older.
• • 4. Fit in the below listed inclusion criteria
• Inclusion Criteria for Test Population (BE and EAC subjects):
• • 1. Previous diagnosis of indefinite Barrett's Esophagus (IND), non-dysplastic (ND), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or esophageal adenocarcinoma (EAC)
• • 2. Able to swallow a Tylenol sized capsule
• • 3. Diagnostic endoscopy performed within past 3 months or able to arrive early to endoscopy for EnteroTracker® to be swallowed before endoscopy
• • Inclusion Criteria for Control Population (otherwise healthy adults with no evidence of BE or EAC or other esophageal cancer but with GERD) 4. Able to swallow a Tylenol sized capsule 5. 45 years of age or older
• • 1. The majority of BE and EAC patients are age 50 years and older. Fewer than 15% of the cases are found in people younger than age 55. However current literature has suggested that there has been an increase in cases among 45-65 years old \[47\].
• 6. Apparently healthy or ≥5 years of:
• • 1. Gastroesophageal Reflux Disease (GERD) symptoms, or
• • 2. GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control was achieved or not), or
• • 3. Any combination of treated and untreated periods if the cumulative total is at least 5 years
• Exclusion Criteria:
• • 1. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills within 3 months of EnteroTracker® procedure
• • 2. Inability to provide written informed consent
• • 3. Pregnant women
• • 4. Prior EGD during which a therapeutic procedure such as, but not limited to, ablation, cryotherapy, or endoscopic mucosal resection, was performed for the treatment of BE and/or EAC
• • 5. Known history of esophageal varices or esophageal stricture
• • 6. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EnteroTracker® procedure
• • 7. Oropharyngeal cancer
• • 8. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication
• • 9. History of esophageal motility disorder
• • 10. Currently implanted Linx device