Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02089386
Status:
TERMINATED
Last Update Posted:
2017-03-13
First Post:
2014-03-13
Brief Title:
Tamoxifen to Treat Barretts Metaplasia
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Tamoxifen to Treat Barretts Metaplasia
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treat Barretts esophagus BE patients with tamoxifen to Barretts metaplasia as measured by changes in Barretts esophagus appearance by endoscopy and histology as well as changes in SOX2 and CDX2
Detailed Description:
Treat Barretts esophagus BE patients with tamoxifen to determine the effects on Barretts metaplasia as measured by changes in Barretts esophagus appearance by endoscopy and histology Tamoxifen treatment may induce SOX2 expression decrease CDX2 and promote esophageal stem cell activity leading to regression of Barretts metaplasia To test this hypothesis we will conduct a prospective pilot study where patients with BE without high grade dysplasia are treated with tamoxifen and assessed for changes in the appearance of their BE by endoscopy and histology as well as changes in the SOX2CDX2 ratio indicative of an improvement in BE metaplasia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None