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Novel Method of Surveillance in Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT00955019
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : September 16, 2009
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Mayo Clinic

Brief 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.

Condition or disease
Barrett Esophagus

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.

Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Method of Surveillance in Barrett's Esophagus
Study Start Date : October 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009



Biospecimen Retention:   Samples Without DNA
cytology specimens


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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:


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)

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 Posted: August 7, 2009    Key Record Dates
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