Novel Method of Surveillance in Barrett's Esophagus - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00955019

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 II

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

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

National Institutes of Health (NIH)

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 February 09, 2012