NCT02089386|TerminatedEarly Phase 1DMCFDA Drug
Study Stopped
Insufficient funding
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Insufficient funding
Sponsor study identifier
interventional
7
1 country
1
Study Start
July 9, 2014
Actual (reported)Primary Completion
June 21, 2016
Actual (reported)Study Completion
June 21, 2016
Actual (reported)Treat Barrett's esophagus (BE) patients with tamoxifen to Barrett's metaplasia as measured by changes in Barrett's esophagus appearance by endoscopy and histology as well as changes in SOX2 and CDX2.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 21, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 13, 2014
Actual (reported)March 17, 2014
Actual (reported)July 9, 2014
Actual (reported)June 21, 2016
Actual (reported)June 21, 2016
Actual (reported)Extent of Barrett's involvement and changes in histology
The biopsy procedures with 4 quadrant biopsies/2 cm for histology and additional biopsies for freezing for macromolecular analysis to assess the preliminary diagnostic value of this marker pair in identifying levels of metaplasia in BE and as an indicator of response to tamoxifen treatment. The tissue from the two endoscopic procedures will be assessed for changes in the following related to tamoxifen therapy.
End of 12 weeks (at the time of second endoscopy)
Changes in SOX2 and CDX2 expression
End of 12 weeks (at the time of second endoscopy)
Tolerance of tamoxifen
4 months (30 days after cessation of tamoxifen or after second endoscopy - whichever occurs later)
Changes in the length of Barrett's esophagus involvement
End of 12 weeks (at the time of second endoscopy)
Tamoxifen 20 mg daily for 12 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Lindblad M, Garcia Rodriguez LA, Chandanos E, Lagergren J. Hormone replacement therapy and risks of oesophageal and gastric adenocarcinomas. Br J Cancer. 2006 Jan 16;94(1):136-41. doi: 10.1038/sj.bjc.6602906.
Huh WJ, Khurana SS, Geahlen JH, Kohli K, Waller RA, Mills JC. Tamoxifen induces rapid, reversible atrophy, and metaplasia in mouse stomach. Gastroenterology. 2012 Jan;142(1):21-24.e7. doi: 10.1053/j.gastro.2011.09.050. Epub 2011 Oct 14.
Jason Mills, M.D., Ph.D.
Washington University School of Medicine
7 participants (actual enrollment reported by the registry).
First Submitted
March 13, 2014
First Posted
March 17, 2014
Study Start
July 9, 2014
Actual (reported)Primary Completion
Expression and Function of the Renin-Angiotensin System in the Esophagus
Contact the study team to confirm eligibility.
June 21, 2016
Actual (reported)Study Completion
June 21, 2016
Actual (reported)Last Updated
March 13, 2017
Record last verified: 2017-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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