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

The sponge on a string (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 the SOS device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.

Inclusion criteria

Aim1:

• Male and female ages 50-85
• Patients who have three or more risk factors for Barrett's Esophagus.
• Gastroesophageal reflux disease defined by:

• Diagnosis
• Use of one of the following drugs >= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine
• prior endoscopic diagnosis of erosive esophagitis
• Body mass index (BMI) >= 30

Exclusion criteria

Aim1 and Aim 3:

• Previous history of:

• esophageal adenocarcinoma/cancer
• esophageal squamous carcinoma
• endoscopic ablation for Barrett's esophagus
• esophageal squamous dysplasia
• Current treatment with oral anticoagulation including Warfarin, Coumadin
• History of cirrhosis
• History of esophageal/gastric varices
• History of Barrett's esophagus
• Prior endoscopy in the last 5 years

Inclusion criteria

Aim 2 and Aim 3:

• Subjects with known or suspected BE (cases).

• Patient between the ages 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.

Exclusion criteria

Aim 2:

• Subjects with known BE.

• 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.
• Patients with history of esophageal resection for esophageal carcinoma.
• 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 (this does not apply to the brushings/biopsies only portion of the study).
• History of eosinophilic esophagitis, achalasia.
• Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
• Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
• Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
• Patients with history of known esophageal or gastric varices or cirrhosis.
• Patients with history of surgical esophageal resection for esophageal carcinoma.
• Patients with congenital or acquired bleeding diatheses.
• Patients with a history of esophageal squamous dysplasia.
• Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
• Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.