Project Details
Description
This proposal is for a four year study with new patient accrual in years 1 and 2. Subjects will be one year on agent or placebo.
Endoscopic visualization of the esophagus will be performed in each subject prior to randomization and at 12 months and 18 months (+/- 2 months) after the qualifying EGD. Each subject will remain on study for 18 months. Total duration of study is 4 years. Biomarkers to be run in year 4.
Study coordinators will identify potential subjects through review of endoscopy schedules and pathology reports. All potential subjects must have had RFA for Barrett’s metaplasia with or without dysplasia and at least two “clean” exams with no histological evidence of BE after complete endoscopic ablation. For individuals who meet this initial criterion, a preliminary determination of eligibility will then be made through review of available medical records and contact with the participating physicians. This coordinator effort is prior to consent and is not billed to the study budget.
Status | Finished |
---|---|
Effective start/end date | 6/15/15 → 6/14/19 |
Funding
- University of Texas M. D. Anderson Cancer Center (Sub#00003350 // HHSN261201200034I)
- National Cancer Institute (Sub#00003350 // HHSN261201200034I)
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