Prevalence of Dysplasia of the Gastric Cardia

Completed

Conditions studied: Barrett's Esophagus, Intestinal Metaplasia, Intramucosal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT01787864

Run by

University of North Carolina, Chapel Hill

People needed

170

Starts

2013-02-01

Expected to finish

2017-05-01

Last updated by the study team

2017-05-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English speaking males or females aged 18 to 80.
• Meet one of the following:
• Individuals who have undergone ablation therapy for dysplastic Barrett's Esophagus (BE) or intramucosal adenocarcinoma and have had at least one clear pathology report with no BE since their first ablation (cross-sectional) OR
• Individuals with dysplastic Barrett's Esophagus (BE) or intramucosal adenocarcinoma who will undergo ablation therapy at UNC for the first time (prospective longitudinal)
• Able to read, comprehend, and complete the informed consent form.

You may not qualify if…

• Bleeding disorder or other contraindication of endoscopic biopsy.
• Current use of blood thinners such as coumadin, warfarin, heparin and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 6 days after Esophagogastroduodenoscopy (EGD)).
• History of partial or complete esophagectomy.
• Current diagnosis of invasive esophageal cancer.
• Prior ablation of the cardia.
• Patients who have received or will receive endoscopic mucosal resection (EMR) on the day of enrollment of the gastric cardia or distal esophagus, defined as the top of the gastric folds (TGF) +2 centimeters through the top of the gastric folds -1 centimeter (TGF+2 through TGF-1). Prior EMR and/or EMR on the day of enrollment of areas other than TGF+2 through TGF-1 are OK.
• Pregnant women.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.