Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia
This phase II trial studies how well ursodiol works in treating patients with Barrett esophagus or low-grade dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of ursodiol may 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 8OHdG immunostaining [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 percentage of positively stained nuclei in BE tissue sections from baseline to post-intervention [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
- 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:||March 2012|
|Estimated Primary Completion Date:||January 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 ursodeoxycholic acid (ursodiol, UDCA) treatment to reverse oxidative deoxyribonucleic acid (DNA) damage in the esophageal epithelium of subjects with Barrett's esophagus (BE).
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.
|United States, Arizona|
|Southern Arizona Veterans Affairs Health Center||Recruiting|
|Tucson, Arizona, United States, 85723|
|Contact: Michael P. Habib 520-792-1450 ext 4651 Michael.Habib@va.gov|
|Principal Investigator: Michael P. Habib|
|University of Arizona Health Sciences Center||Recruiting|
|Tucson, Arizona, United States, 85724|
|Contact: Bhaskar Banerjee 520-626-6119 email@example.com|
|Principal Investigator: Bhaskar Banerjee|
|United States, North Carolina|
|University of North Carolina||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Nicholas J. Shaheen 919-966-2513 firstname.lastname@example.org|
|Principal Investigator: Nicholas J. Shaheen|
|Principal Investigator:||Bhaskar Banerjee||University of Arizona Health Sciences Center|