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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00955019
Other study ID # 07-002322
Secondary ID CA122426
Status Completed
Phase Phase 2
First received August 5, 2009
Last updated September 14, 2009
Start date October 2007
Est. completion date September 2009

Study information

Verified date September 2009
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Other known NCT identifiers
  • NCT00629109

Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date September 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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