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

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.

Eligibility Criteria:
Inclusion Criteria arm 1:

1. Male and female ages 50-85
2. Primary Care patients from Mayo Clinic Rochester or Mayo Clinic Health Systems.
3. Patients who have three or more risk factors for Barrett's Esophagus.

Exclusion Criteria arm 1:

1. History of Barrett's esophagus or esophageal adenocarcinoma.
2. Prior endoscopy in the last 5 years.
3. Pregnant or lactating females.
4. Patients who are unable to consent.
5. Patients with current history of uninvestigated dysphagia
6. History of eosinophilic esophagitis, achalasia.
7. Patients on oral anticoagulation including Coumadin, Warfarin.
8. Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge/endoscopy procedure (Visit 2 and 3).
9. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge/endoscopy procedure (Visit 2 and 3).
10. Patients with history of known esophageal/gastric varices or cirrhosis.
11. Patients with history of esophageal resection due to carcinoma.
12. Patients with congenital or acquired bleeding diatheses.
13. Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
14. Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
15. Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Inclusion criteria arm 2:

1. Subjects with known or suspected BE (cases).

   1. Patient between the ages 18 - 90.
   2. Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
   3. Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
   4. Undergoing clinically indicated endoscopy.
2. Subjects without known history of BE (controls). 1. Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria arm 2:

1. Subjects with known BE.

   1. Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded.
   2. Patients with history of esophageal resection for esophageal carcinoma.
2. For subjects with or without known evidence of BE (on history or review of medical records):

   1. Pregnant or lactating females.
   2. Patients who are unable to consent.
   3. Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
   4. History of eosinophilic esophagitis, achalasia.
   5. Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
   6. Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
   7. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
   8. Patients with history of known esophageal or gastric varices or cirrhosis.
   9. Patients with history of surgical esophageal resection for esophageal carcinoma.
   10. Patients with congenital or acquired bleeding diatheses.
   11. Patients with a history of esophageal squamous dysplasia.
   12. Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
   13. Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.