Overview

This trial is active, not recruiting.

Condition barrett's esophagus
Sponsor Mayo Clinic
Start date May 2012
End date May 2017
Trial size 253 participants
Trial identifier NCT02066701, 12-001575

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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
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

Primary Outcomes

Measure
to determine if assay of aberrantly methylated gene markers can discriminate Barrett's Esophagus tissue (and presence of dysplasia) from esophageal squamous and gastric cardia tissue.
time frame: 1 day

Secondary Outcomes

Measure
Assess the accuracy of candidate markers in stool for detection of Barrett's Esophagus
time frame: One day

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Utility of Aberrant Gene Methylation in the Diagnosis of Barrett's Esophagus: Identification of Candidate Diagnostic Markers
Principal investigator Prasad G Iyer, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.