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NCT01787864 · ClinicalTrials.gov registry record
Prevalence of Dysplasia of the Gastric Cardia
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 170
- Enrollment target
NCT01787864: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT01787864 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 170 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01787864 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 170 participants
- Enrollment target
Study Summary
We propose a tissue sample collection study for patients at UNC who have undergone or will undergo radiofrequency ablation therapy for Barrett's Esophagus (BE) or intramucosal adenocarcinoma as part of routine medical care. Purpose: To determine the prevalence of metaplasia and dysplasia in the gastric cardia before and after ablative therapy. To determine the incidence of cardiac metaplasia and dysplasia as a function of ablative therapy. To determine the correlation between dysplasia in the tubular esophagus, and dysplasia in the cardia. To assess the ability of immunohistochemical (IHC) staining of cardia tissues to predict incident dysplasia in the cardia. Several well-characterized biomarkers, including p16, p53, Ki67, cyclin D1, and cyclin A, will be assessed.
Primary Outcome
Simple proportions will be generated to describe the prevalence of cardiac dysplasia prior to endoscopic ablation. To compare the proportion of subjects demonstrating cardiac dysplasia who have had complete eradication of Barrett's Esophagus (BE) to the proportion of subjects demonstrating cardiac dysplasia who have not had complete eradication of Barrett's Esophagus (BE), due to the dichotomous nature of the variable, we will initially create 2x2 contingency tables and perform bivariate analysi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2013-02 |
| Est. Completion | 2017-05 |
What the finished NCT01787864 record still lists
NCT01787864 is an observational study that tracks outcomes without assigning an intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01787864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01787864 about?
NCT01787864 is a clinical study titled "Prevalence of Dysplasia of the Gastric Cardia". We propose a tissue sample collection study for patients at UNC who have undergone or will undergo radiofrequency ablation therapy for Barrett's Esophagus (BE) or intramucosal adenocarcinoma as part of routine medical care. Purpose: To determine the prevalence of metaplasia and dysplasia in the ga...
What is the current status of trial NCT01787864?
This trial is currently completed. The enrollment target is 170 participants. The study started on 2013-02. Estimated completion is 2017-05.
Who is sponsoring clinical trial NCT01787864?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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