Prevalence of Dysplasia of the Gastric Cardia
Condition: Barrett's Esophagus; Intestinal Metaplasia; Intramucosal Adenocarcinoma
MeSH terms: Adenocarcinoma; Barrett Esophagus; Metaplasia
Study type: Observational

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.
    

Detailed description: 
      This study will consist of a cross-sectional arm, as well as a prospective longitudinal arm,
      and will include patients who are undergoing ablative therapy at UNC. The cross-sectional arm
      will consist of patients who have undergone ablative therapy for Barrett's Esophagus (BE) and
      have had at least one clear pathology report with no evidence of Barrett's Esophagus (BE)
      since their first ablation. Concurrently enrolled will be a prospective longitudinal arm
      which will consist of patients prior to their first ablation procedure. The prospective
      cohort will be followed for 12 months or longer if Barrett's Esophagus (BE) is not yet clear
      6 months after the initial treatment.

      Sampling of the gastric cardia for clinical pathology has become common in patients who are
      receiving or have received ablation therapy based on evidence from previous research
      suggesting concern for dysplasia in the gastric cardia. In each group, research biopsies will
      be taken at the top of the gastric folds (TGF) as well as the gastric cardia (TGF+1cm) and
      distal esophagus (TGF-1).

      Clinical biopsies will consist of standard esophageal biopsies from the distal esophagus as
      well as biopsies from TGF, TGF+1cm and TGF+2 cm. Clinical biopsy specimens will be fixed and
      reviewed by a pathologist to determine the presence of any metaplastic, dysplastic, or
      neoplastic changes, as per our usual clinical practice. Research specimens will undergo
      immunohistochemical (IHC) staining for a number of biomarkers that have been found to be
      positive in patients with dysplastic BE (p16, p53, Ki67, cyclin D1, and cyclin A). 1-4
      Cross-sectional participants will receive one-time study biopsies. Prospective longitudinal
      participants will receive biopsies prior to ablation therapy and 6 and 12 months after the
      initial treatment. If Barrett's Esophagus (BE) is not yet clear at 6 months, biopsies will be
      taken at the first endoscopy after Barrett's Esophagus (BE) clearance and again at the next
      clinically scheduled follow-up visit.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        This study will consist of a cross-sectional arm, as well as a prospective longitudinal
        arm, and will include patients who are undergoing ablative therapy at UNC. The
        cross-sectional arm will consist of patients who have undergone ablative therapy for
        Barrett's Esophagus (BE) and have had at least one clear pathology report with no evidence
        of BE since their first ablation. Concurrently enrolled will be a prospective longitudinal
        arm which will consist of patients prior to their first ablation procedure. The prospective
        cohort will be followed for 12 months after initial treatment or longer if BE is not yet
        clear 6 months after the initial treatment.
      
Biospecimen description: 
      Esophageal and gastric cardia biospies
    
Keywords: Barrett's Esophagus; Intestinal metaplasia; Intramucosal Adenocarcinoma; Gastric Cardia; High Cardia Dysplasia; Radiofrequency ablation (RFA)