Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia
This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.
• Subjects with known or suspected Barrett's esophagus (BE) (cases)
‣ Patients between the ages of 18-90.
⁃ Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
⁃ Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
⁃ Undergoing clinically indicated endoscopy.
• Subjects without known history of BE (controls)
‣ Undergoing clinically indicated diagnostic endoscopy