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PURPOSE: This phase II trial is studying how well ursodiol works in treating patients with Barrett esophagus or low-grade dysplasia.
- 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).
- 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.
Masking: Open Label, Primary Purpose: Prevention
ursodiol, high performance liquid chromatography, immunohistochemistry staining method, laboratory biomarker analysis, mass spectrometry
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:14:50-0400
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Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed.
A method of separation of two or more substances by repeated distribution between two immiscible liquid phases that move past each other in opposite directions. It is a form of liquid-liquid chromatography. (Stedman, 25th ed)
A CHROMATOGRAPHY method using supercritical fluid, usually carbon dioxide under very high pressure (around 73 atmospheres or 1070 psi at room temperature) as the mobile phase. Other solvents are sometimes added as modifiers. This is used both for analytical (SFC) and extraction (SFE) purposes.
Fractionation of a vaporized sample as a consequence of partition between a mobile gaseous phase and a stationary phase held in a column. Two types are gas-solid chromatography, where the fixed phase is a solid, and gas-liquid, in which the stationary phase is a nonvolatile liquid supported on an inert solid matrix.
Chromatographic techniques in which the mobile phase is a liquid.
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