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Novel Method of Surveillance in Barrett's Esophagus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00955019
First Posted: August 7, 2009
Last Update Posted: September 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Mayo Clinic
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
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): NCT00955019


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
  More Information

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
First Submitted: August 5, 2009
First Posted: August 7, 2009
Last Update Posted: September 16, 2009
Last Verified: September 2009

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