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Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia

2014-08-27 03:14:50 | BioPortfolio

Summary

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well ursodiol works in treating patients with Barrett esophagus or low-grade dysplasia.

Description

OBJECTIVES:

Primary

- To evaluate the ability of ursodiol to reverse oxidative DNA damage in the esophageal epithelium of subjects with Barrett esophagus (BE) and low-grade dysplasia (LGD).

Secondary

- To determine the effects of ursodiol on gastric bile acid composition and on cell proliferation of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral ursodiol twice daily for 6 months in the absence of disease progression or unacceptable toxicity.

Tissue and gastric fluid samples are collected during standard endoscopy, at baseline and after completion of study for biomarker analysis by IHC and high-performance liquid chromatography tandem mass spectrometry.

After completion of study therapy, patients are followed up for 2 weeks.

Study Design

Masking: Open Label, Primary Purpose: Prevention

Conditions

Esophageal Cancer

Intervention

ursodiol, high performance liquid chromatography, immunohistochemistry staining method, laboratory biomarker analysis, mass spectrometry

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:50-0400

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