Clinical trial · Observational
Prevalence of Dysplasia of the Gastric Cardia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Intestinal Metaplasia | — | UNRESOLVED | — |
| Intramucosal Adenocarcinoma | Intramucosal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cross-Sectional Post-Ablation
- description
- 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. Cross-sectional participants will receive one-time study biopsies during a routine care follow-up endoscopy.
- label
- Prospective Longitudinal Pre-Ablation
- description
- 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. 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.
Primary outcomes (1)
- measure
- Presence of dysplasia before and after ablation
- timeFrame
- Enrollment and 6 and 12 months post treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * English speaking males or females aged 18 to 80. * Meet one of the following: 1. 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 2. 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available