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

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ClinicalTrials.gov Identifier: NCT02066701
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic

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.

Condition or disease
Barrett's Esophagus

Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Utility of Aberrant Gene Methylation in the Diagnosis of Barrett's Esophagus: Identification of Candidate Diagnostic Markers
Study Start Date : May 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Endoscopy Barrett's
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
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 Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Tissue and cytology brushes will be stored for the duration of the study


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for clinically indicated upper endoscopy will be approached to participate in this study
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066701


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Prasad G Iyer, MD Mayo Clinic

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02066701     History of Changes
Other Study ID Numbers: 12-001575
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017

Keywords provided by Prasad G. Iyer, Mayo Clinic:
Barrett's esophagus

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases