Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma

Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma- Renewal Grant Aim 2 (The SOS6C Trial)

This study explores the use of a minimally invasive screening tool (a sponge on a string device) to detect Barrett's esophagus and esophageal adenocarcinoma and to develop a laboratory test for the detection of Barrett's esophagus-high grade dysplasia and esophageal adenocarcinoma.

Inclusion Criteria:

• Patient between the ages 18 - 90
• Patients with a BE segment >= 1cm in maximal extent endoscopically
• Histology showing evidence of intestinal metaplasia with or without presence of dysplasia
• Undergoing clinically indicated endoscopy

Exclusion Criteria:

• Patients with a prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with a history of endoscopic mucosal resection alone will not be excluded

• Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma

• Subjects with known evidence of BE (on history or review of medical records)

  • Pregnant or lactating females
  • Patients who are unable to consent
  • Patients with a current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study for RST/ARZ sites only)
  • History of eosinophilic esophagitis or achalasia
  • Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for thee to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
  • Patients on antiplatelet agents including clopidogrel, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
  • Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
  • Patients with a history of known esophageal or gastric varices or cirrhosis
  • Patients with a history of esophageal or gastric resection
  • 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
  • Patients with Familial Adenomatous Polyposis (FAP) or Lynch Syndrome