Novel Method of Surveillance in Barrett's Esophagus

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00955019
First received: August 5, 2009
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

This study is being done to see how biomarkers (abnormalities in molecules of cells ) present in their Barrett's esophagus agree with results from surveillance biopsies; and to compare three different brush devices used to collect cells to see which of these 3 brush devices obtains a higher number of cells.


Condition Phase
Barrett Esophagus
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Method of Surveillance in Barrett's Esophagus

Further study details as provided by Mayo Clinic:

Biospecimen Retention:   Samples Without DNA

cytology specimens


Estimated Enrollment: 180
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

During an endoscopy done for clinical surveillance of your Barrett's Esophagus participants are randomized to one of three brush devices by random chance like a flip of a coin. This is being done to see if one collects more cells than the others. A soft brush will be used to collect cells from the lining of the esophagus, this is known as brush cytology. With the endoscope positioned in your esophagus, samples (biopsies) of lining of the esophagus will then be taken to determine the nature of the Barrett's mucosa in the same manner as for any patient undergoing routine surveillance endoscopy for Barrett's esophagus. A part of the specimen will be used to store tissue samples that can later be used.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with barretts esophagus

Criteria

Inclusion Criteria:

  • Patient age greater than 18 years of age
  • Prior histological demonstration of Barretts Esophagus that is endoscopically visible with no dysplasia
  • Low grade, high grade dysplasia or early esophageal cancer

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955019

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Kenneth K. Wang, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00955019     History of Changes
Obsolete Identifiers: NCT00629109
Other Study ID Numbers: 07-002322, CA122426
Study First Received: August 5, 2009
Last Updated: September 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's
Esophagus
Reflux
dysplasia
adenocarcinoma

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

ClinicalTrials.gov processed this record on October 19, 2014