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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Utility of Aberrant Gene Methylation in the Diagnosis of Barrett's Esophagus: Identification of Candidate Diagnostic Markers

Brief 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.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: 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 ]

we will plan to identify the best markers from highly selected marker candidates to differentiate between subjects who have BE and those who do not have BE.


Original Primary Outcome: to determine if assay of aberrantly methylated gene markers can discriminate Barrett's Esophagus tissue from esophageal squamous and gastric cardia tissue. [ Time Frame: 1 day ]

we will plan to identify the best markers from highly selected marker candidates to differentiate between subjects who have BE and those who do not have BE.


Current Secondary Outcome: Assess the accuracy of candidate markers in stool for detection of Barrett's Esophagus [ Time Frame: One day ]

Assess the ability of stool markers to distinguish between subjects who have BE and those who do not.


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: February 3, 2014
Date Started: May 2012
Date Completion: May 2017
Last Updated: September 15, 2016
Last Verified: September 2016