Overview
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.
Description
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.
Eligibility
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.
