Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 2:01 AM
Study NCT ID:
NCT01097304
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2010-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Clinical Study of Ursodeoxycholic Acid in Barrett's Patients
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
I. To determine the effects of UDCA treatment on gastric bile acid composition and on cell proliferation in Barrett's epithelium.
OUTLINE:
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.
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.
SECONDARY OBJECTIVES:
I. To determine the effects of UDCA treatment on gastric bile acid composition and on cell proliferation in Barrett's epithelium.
OUTLINE:
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00450 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000669111 | None | None | View | |
| 09-0141-03 | OTHER | University of Arizona Health Sciences Center | View | |
| UAZ08-11-01 | OTHER | DCP | View | |
| P50CA095060 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CN35158 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |