Trial record 7 of 148 for:    barretts and mayo

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02066701
First received: February 3, 2014
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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
Barrett's Esophagus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Assess the accuracy of candidate markers in stool for detection of Barrett's Esophagus [ Time Frame: One day ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patient scheduled for clinically indicated upper endoscopy will be approached to participate in this study

Criteria

Inclusion Criteria:

  • Exclusion criteria for cases and controls:

Patients with history of esophagectomy or mucosal ablation, gastric fundoplication or other gastric surgery, 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/esophageal/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).

Control patients without endoscopic evidence of Barrett's will be frequency matched by age (± 5 years) and gender (similar distribution) to cases. To ensure similar age and gender distribution between cases and controls, monitoring of recruited cases and controls age and gender distribution will be performed every two weeks. Data on height, weight, smoking history, medications (NSAIDS, PPIs) and indications (as well as findings on endoscopy) for endoscopy will be abstracted from medical records. All participants will be >18 years of age and will provide informed consent.

Exclusion Criteria:

  • Exclusion criteria for cases:

Patients with history of esophagectomy or mucosal ablation, gastric fundoplication or other gastric surgery, 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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02066701     History of Changes
Other Study ID Numbers: 12-001575
Study First Received: February 3, 2014
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's esophagus

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

ClinicalTrials.gov processed this record on April 23, 2014