Gene Methylation in the Diagnosis of Barrett's Esophagus: Identification of Candidate Diagnostic Markers

Mayo Clinic

Status: Completed

Conditions: Barrett's Esophagus

Study type: Observational

Funder types: Other

Identifiers

NCT02066701

12-001575

Details and patient eligibility

About

This study is to identify potential markers from esophageal biopsies and brush cytology for feasibility of use in stool specimens for detection of Barretts Esophagus.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Controls: No endoscopic evidence of Barrett's Esophagus, able to give informed consent, 18 years of age or older.

Cases: At least 1 cm of visible columnar epithelium with intestinal metaplasia on histology confirmed by an expert GI pathologist (on biopsy), able to give informed consent, 18 years of age or older.

Exclusion criteria

Controls: Patients with history of esophagectomy or mucosal ablation, gastrectomy, or known non-Barrett's esophageal pathology (e.g. eosinophilic esophagitis or achalasia), varices, esophagitis LA Grade B, C, D will be excluded. Patients with prior history of colon polyps or colon/esophageal/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).

Cases: Patients with history of esophagectomy or mucosal ablation, gastrectomy, or known non-Barrett's esophageal pathology (e.g. eosinophilic esophagitis or achalasia), will be excluded. Patients with prior history of colon polyps or colon/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).

Trial design

250 participants in 2 patient groups

Endoscopy Barrett's

Description:

Patients undergoing clinically indicated upper endoscopy will be invited to participate. Patients who are known to have Barrett's Esophagus as well as patient who do not will be approached for enrollment

Endoscopy control

Description:

Patients undergoing clinically indicated upper endoscopy will be invited to participate. Patients who are known to have Barrett's Esophagus as well as patient who do not will be approached for enrollment