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Prevalence of Dysplasia of the Gastric Cardia

NCT01787864 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2017-05-16

No results posted yet for this 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.

Conditions

  • Barrett's Esophagus
  • Intestinal Metaplasia
  • Intramucosal Adenocarcinoma

Sponsors & Collaborators

  • CSA Medical, Inc.

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Nicholas Shaheen, MD, MPH · UNC Chapel Hill

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01787864 on ClinicalTrials.gov