Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia
This pilot phase II trial studies how well ursodiol works in treating patients with Barrett esophagus or cells that look abnormal under a microscope but are not cancer (low-grade dysplasia). Chemoprevention is the use of certain drugs to keep cancer from forming. The use of ursodiol may keep cancer for forming in patients with Barrett esophagus or low-grade dysplasia.
Other: Laboratory Biomarker Analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Clinical Study of Ursodeoxycholic Acid in Barrett's Patients|
- Reversal of Oxidative DNA Damage as Assessed by Changes in 8-hydroxy-2' -Deoxyguanosine (8OHdG) Immunostaining [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]8OHdG will be assessed by percentage of positively stained nuclear area. A paired t-test at a one-sided 0.05 significance level will be used to assess change during intervention. The observed results will be reported along with the corresponding confidence intervals.
- Changes in Gastric Bile Acid Composition, Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]Results will be analyzed using paired t-tests. Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.
- Changes in Cell Proliferation in BE Epithelium From Baseline to Post-intervention as Assessed by Proliferation-related Ki-67 Antigen (Ki67) Immunostaining, Percentage of Positively Stained Nuclei, in BE Tissue Sections [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]Results will be analyzed using paired t-tests. Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.
|Study Start Date:||April 2010|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (ursodiol)
Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Laboratory Biomarker Analysis
I. To evaluate the ability of UDCA (ursodiol) treatment to reverse oxidative deoxyribonucleic acid (DNA) damage in the esophageal epithelium of subjects with Barrett's esophagus.
I. To determine the effects of UDCA treatment on gastric bile acid composition and on cell proliferation in Barrett's epithelium.
Patients receive ursodiol orally (PO) twice daily (BID) for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up for 2 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097304
|United States, Arizona|
|Arizona Cancer Center-North Campus|
|Tucson, Arizona, United States, 85724-5024|
|Southern Arizona Veterans Affairs Health Center|
|Tucson, Arizona, United States, 85723|
|University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Bhaskar Banerjee||University of Arizona Health Sciences Center|