Racial Disparity in Barrett's Esophagus

NCT ID: NCT01374074

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 255 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-01-31

Brief Summary

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.

Detailed Description

The goal of the proposed research is to investigate the molecular mechanisms of racial disparity in Barrett's esophagus, 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.

Participants: Patients aged 18-80 presenting at the Gastrointestinal (Gl) Endoscopy Clinic at UNC-Chapel Hill for elective upper endoscopy with a primary or secondary indication of reflux symptoms.

Procedures (methods): Endoscopic biopsy, pH impedance and sampling of gastric secretions will be performed according to our standard protocol. A series of questionnaires assessing demographics, environmental exposure (e.g., smoking, drinking), markers of socioeconomic status (SES), body measurement, previous health history, and gastroesophageal reflux disease (GERD) symptomatology will be administered to our subjects.

Conditions

Barrett's Esophagus; Gastroesophageal Reflux Disease (GERD); Intestinal Metaplasia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

White GERD

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.

No interventions assigned to this group

African American GERD

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.

No interventions assigned to this group

White BE

Participants who self-identify as "not-Hispanic or Latino" and "White" and have been diagnosed by a physician with Barrett's Esophagus.

No interventions assigned to this group

African American BE

Participants who self-identify as "not-Hispanic or Latino" and "African American" and have been diagnosed by a physician with Barrett's Esophagus.

No interventions assigned to this group

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Shaheen, MD

Professor of Medicine and Epidemiology Director, Center for Esophageal Diseases and Swallowing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Shaheen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Xiaoxin Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

North Carolina Central University

Locations

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

U54CA156735

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-0008

Identifier Type: -

Identifier Source: org_study_id