Clinical trial · Observational
Racial Disparity in Barrett's Esophagus
- 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)
The goal of the proposed research is to investigate the molecular mechanisms of racial disparity in Barrett's esophagus (BE), the premalignant lesion of esophageal adenocarcinoma. Specifically, the investigators hypothesize that environmental factors, genetic factors, and potentially gene environment interactions play crucial roles in the observed racial disparity in developing Barrett's esophagus. Patients are recruited through UNC hospitals prior to scheduled esophagogastroduodenoscopy (EGD). Participants complete a questionnaire, have body measurements obtained, and have blood, biopsies, and gastric aspirate collected. Participants also complete a 24 hour pH impedance test.
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 | — |
| Gastroesophageal Reflux Disease (GERD) | — | UNRESOLVED | — |
| Intestinal Metaplasia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- White GERD
- description
- Participants who self-identify as "not-Hispanic or Latino" and "White" and have been diagnosed by a physician with gastroesophageal reflux disease and do not have Barrett's esophagus.
- label
- African American GERD
- description
- Participants who self-identify as "not-Hispanic or Latino" and "African American" and have been diagnosed by a physician with gastroesophageal reflux disease and do no have Barrett's esophagus.
- label
- White BE
- description
- Participants who self-identify as "not-Hispanic or Latino" and "White" and have been diagnosed by a physician with Barrett's Esophagus.
- label
- African American BE
- description
- Participants who self-identify as "not-Hispanic or Latino" and "African American" and have been diagnosed by a physician with Barrett's Esophagus.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 to 80 * Self-identify is "not Hispanic or Latino" and either "African American" or "White." * Cases will be eligible for inclusion if they have endoscopically evident Barrett's Esophagus (BE) of any length. BE will be defined as: 1) Any upward displacement of the squamocolumnar junction noted on endoscopy such that the interface of squamous and columnar mucosa is no longer at the interface of the most distal tubular esophagus and the proximal gastric folds. The characteristic pale pink coloration of the squamous epithelium in these areas will be replaced by the darker salmon color commonly seen in BE. 2) Histologic interpretation of biopsies consistent with intestinal columnar metaplasia containing goblet cells, which are positively stained by Alcian blue staining as barrel-shaped cells. * Controls will be eligible for inclusion if they have classic symptoms of gastroesophageal reflux disease (GERD), but no endoscopic or histological evidence of BE. Both erosive and non-erosive GERD will be eligible. Because we expect GERD to outnumber BE and patients with GERD may be slightly less willing to participate in the study than patients with BE (based on recruitment for the studies noted above), we plan to randomly sample one fourth of eligible controls. If approximately 20% fewer GERD than BE participate, a final study population with an approximately 1:2 BE to GERD ratio will be achieved. Oversampling of patients with GERD will improve study power. Exclusion Criteria: * Patients who are unable to read or comprehend the informed consent or written questionnaires; * Patients who are status post partial or complete esophageal resection; * Patients with prevalent BE who have undergone endoscopic ablation; * Patients found to have high-grade dysplasia or esophageal cancer on the index endoscopy; * Patients with surgical anti-reflux procedures; * Patients of races other than Caucasian and African Americans; * Pregnant women. * Patients with a bleeding diathesis or other contraindication of endoscopic biopsy. * Current use of warfarin, heparin, and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 7 days after EGD).
References
Publications (0)
Data not yet available