Novel Method of Surveillance in Barrett's Esophagus

NCT ID: NCT00955019

Last Updated: 2009-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Barrett Esophagus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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CA122426

Identifier Type: -

Identifier Source: secondary_id

07-002322

Identifier Type: -

Identifier Source: org_study_id

NCT00629109

Identifier Type: -

Identifier Source: nct_alias

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