Racial Disparity in Barrett's Esophagus

NCT01374074 | Completed DMC

• 2 other identifiers: 11-0008U54CA156735
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Barrett's Esophagus (BE); Intestinal metaplasia; Gastroesophageal reflux disease (GERD); Racial Disparity

Outcome Measures

Primary Outcomes (1)

• To examine the association between BE and environmental factors

  Odds ratios (ORs) and 95% confidence intervals (CI) will be used to estimate the association between gastroesophageal reflux disease (GERD) and Barrett's esophagus (BE) among Caucasian Americans and African Americans, separately, in relation to patterns of the exposures of interest (tobacco use, alcohol consumption, fruit and vegetable intake and other dietary measures, no NSAID use, and various measures of SES), with adjustments made for the frequency matching factors, age at reference (date of diagnosis for cases and date of identification for controls) and sex.

  Enrollment (day 1)

Secondary Outcomes (1)

• To investigate the association between BE and genetic and epigenetic status of Cdx1/Cdx2

  Enrollment (day 1)

Study Arms (4)

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.

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.

White BE

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

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The source of the study population will be 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. Any patient undergoing endoscopy with classic reflux symptoms is eligible to participate in the study. These symptoms include a substernal chest burning or warmth, a "waterbrash" sensation, regurgitation, or any chest pain worst when supine or after meals. Race will be self-identified race or ethnicity (SIRE) from a researcher-provided list. According to the NIH Policy on Reporting Race and Ethnicity Data published in August 8, 2001 (NOT-OD-01-053), we will "use two separate questions with ethnicity information collected first followed by the option to select more than one racial designation." Patients in this study should be "Not Hispanic or Latino", and either "African American" or "White".

You may qualify if:

• Aged 18 to 80
• Self-identify is "not Hispanic or Latino" and either "African American" or "White."

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, buffy, esophageal biopsies

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Nicholas Shaheen, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Xiaoxin Chen, MD, PhD

  North Carolina Central University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology Director, Center for Esophageal Diseases and Swallowing

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 15, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

US (1)