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Those that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.

Those that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.

Those that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.

Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Sponge Capsule

Clinical Trials Referral Office

Katelyn Valdez

Francisco Ramirez, MD

Kristen Lozano

Herbert Wolfsen, MD

Ramona Lansing, RN

Eduardo Antpack, MD

Grace Dosanjh, M.D.

Ramona Lansing, R.N.

Prasad G. Iyer, M.D.

Molly Stewart

Arvind Trindade, MD

Shamel Brown

Felicia Padilla

Vani Konda, MD

Rebecca L. Schmidt, R.N.

Melissa Passe

Sebastian G. Strobel, M.D.

This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.

The SOS device will be safely administered by a non-physician such as a nurse. Novel discriminant methylated DNA markers will be assayed on esophageal cytology specimens obtained from a sponge on a string (SOS) device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.

Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma

To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.

Compare the sensitivity and specificity of a predetermined BE prediction algorithm for those with and without GERD and assess the influence of other covariates (age, sex, ever smoking, ethnicity and BMI) on this algorithm.

Measure the sensitivity and specificity of a predetermined MDM panel assayed on SOS specimens from BE patients identified in Aims 1 and 2, for the detection of HGD /EAC, using surveillance histology as the criterion standard.

Compare positive predictive value and negative predictive value of the sponge capsule Barrett's Esophagus test between those with and without chronic GERD.

Safety and tolerability of the sponge capsule device in a screening population as measured by a Tolerability Questionnaire with sponge capsule procedure. Participants will rate their tolerability by rating questions using a scale of 0-10 (0 is none and 10 is severe or 0 is good and 10 is not good).

Validate specificity and sensitivity cut offs of a BE prediction algorithm in an independent patient cohort

Measure diagnostic uncertainty bias in the criterion standard, specifically, the rate of dysplasia missed by surveillance histology

Spots Global Cancer Trial Database for sponge capsule