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.
For subjects with or without known evidence of BE (on history or review of medical records)
Pregnant or lactating females.
Patients who are unable to consent.
Patients with current history of uninvestigated dysphagia.
Parallel
Cytosponge Procedure
DeviceInvestigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
Endoscopic Assessment
Diagnostic testParticipants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
DNA yield from esophageal cytology samples collected with the Cytosponge device
DNA concentration from samples collected with the Cytosponge device will be compared with DNA concentration previously observed from samples collected with the EsophaCap device on another study. The DNA concentration range for EsophaCap collected specimens ranged from 0.4 to 285ng/uL.
Accuracy of the Oncoguard Esophagus (OGE) test
Methylated DNA marker (MDM) levels and accuracy (sensitivity and specificity) will be evaluated to determine the accuracy of the OGE test using Cytosponge-collected esophageal samples. Accuracy will be established using upper endoscopy with pathology confirmed histology as the criterion standard for the diagnosis of Barrett's Esophagus (BE). The recently established algorithm for defining the OGE test as positive or negative (from EsophaCap samples collected from another study) will be utilized to adjudicate the Cytosponge samples as positive or negative. Accuracy of the OGE test for the Cytosponge device will be assessed in relation to the estimates and confidence intervals previously observed.
Tolerability of the Cytosponge device
Tolerability will be assessed with a 6-question Tolerability Questionnaire using a 0-10 pain scale where 0 is none and 10 is severe (0 is good and 10 is not good).
Trauma to the esophagus from the passage of the Cytosponge device
Presence of any trauma from the passage of the sponge will be assessed and recorded photographically during the sedated endoscopy. This will be defined as: No evidence of trauma; Superficial mucosal abrasion without bleeding; Superficial mucosal tear abrasion with minimal oozing similar to that from biopsy; Deep mucosal abrasion without bleeding; Deep mucosal abrasion with greater than minimal oozing; or Bleeding requiring endoscopic therapy or perforation.
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