Non-Endoscopic Detection of Barrett's Esophagus and Esophageal Neoplasia Using Methylation Biomarkers on Endosign® Cell Collection Device Samples
This study is looking at cells collected from the esophagus using a diagnostic device called the EndoSign® Cell Collection Device (a sponge on a thread). Subjects swallow a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread. These cells will be tested to check for a condition called Barrett's Esophagus. The cells from the sponge will be tested using Cyted Health biomarkers and compared to the results from a regular endoscopy and any biopsies that are taken. To do this, we need sponge samples from people who might have Barrett's Esophagus based on their risk factors, and from people with Barrett's Esophagus. Subjects will have one visit to have the Endosign Cell Collection Device administered prior to having a standard of care endoscopy. They will answer some questions about their medical history and experience with the cell collection procedure as part of the study. Data will be collected from medical records including post-endoscopy.
• Undergoing a standard of care EGD
• Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD or same day as EGD).
• Willing and able to sign informed consent
• Must have chronic GERD as defined in the ACG Guidelines
• Must have at least 3 additional risk factors as defined in the ACG guidelines such as:
• Age ≥ 50
• Family history of Barrett's esophagus or esophageal adenocarcinoma
• Current or former smoker
• Obesity (BMI greater than or equal to 30 kg/m2)
• Male
• Non-Hispanic White
• Undergoing a standard of care EGD (with or without endoscopic eradication therapy {EET})
• Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD/EET or day of EGD/EET).
• Willing and able to sign informed consent
• Confirmed Barrett's Esophagus of length at least 1 cm or greater. This includes non-dysplastic Barrett's, low-grade dysplasia, high-grade dysplasia or adenocarcinoma.