Evaluation of the Cytosponge Device for Detecting Barretts Esophagus Using Non-Endoscopic Molecular Testing with the Oncoguard Esophagus Test

What this Trial Is About

Researchers are evaluating the use of the Cytosponge, a minimally invasive device for collecting esophageal cells, to detect Barretts esophagus BE and esophageal adenocarcinoma EAC in patients undergoing endoscopy. This approach combines the Cytosponge with the Oncoguard Esophagus test OGE test, which identifies biomarkers indicating the presence of BE or EAC. The study aims to assess DNA yield from samples collected with the Cytosponge and the accuracy of the OGE test in detecting methylated DNA markers. Additionally, the study evaluates the tolerability and safety of the Cytosponge device. Participants are assigned to one of two groups those with known or suspected BE and those without known BE. Both groups undergo the Cytosponge procedure followed by a clinically indicated sedated endoscopy using standard equipment. The Cytosponge device is administered and retrieved according to instructions, then placed in a preservative solution and sent for laboratory analysis. Participants complete surveys during the study to report tolerability and any symptoms. During the study, researchers measure DNA yield and the accuracy of the OGE test over 12 months. They also assess the tolerability of the Cytosponge device and check for any esophageal trauma within 7 days using questionnaires and endoscopic injury scores. The study includes standard endoscopic evaluations and collects participant feedback to understand the experience. The total participation period covers these assessments and follow-ups as scheduled.

Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples