Risk Factors for Barrett's Esophagus in Patients With BE, Gastroesophageal Reflux, or Gastrointestinal Bleeding

Molecular Epidemiology of Barrett's Esophagus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00445653

Enrollment

170

Registered

2007-03-09

Start date

2005-08-31

Completion date

2013-03-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precancerous Condition

Keywords

Barrett esophagus

Brief summary

RATIONALE: A study that evaluates DNA changes and other disease-related health information in patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding may help doctors learn more about the risk factors for Barrett's esophagus. PURPOSE: This clinical trial is looking at DNA changes and other disease-related health information as risk factors for Barrett's esophagus in patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding.

Detailed description

OBJECTIVES: * Assess the role of several genetically determined factors that, in combination with CagA status, cigarette smoking, alcohol, and diet to varying degrees, result in an increased risk for Barrett's esophagus. OUTLINE: This is a controlled study. Patients complete questionnaires about demographics, medical history, smoking and alcohol history, current medications, frequency and chronicity of gastroesophageal reflux symptoms, and diet history. Blood and tissue are collected and analyzed by DNA-based assays and enzyme-linked immunosorbent assay for CagA status and polymorphisms in detoxifying enzyme systems, other xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4, CYP3A5, NQO, NAT-2), inflammatory gene pathways (e.g., IGF, IGFBF3), and in DNA repair genes or p53 pathways (e.g., XRCC1, p53 gene). PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Undergoing elective esophagogastroduodenoscopy for any of the following reasons: * Surveillance of Barrett's esophagus * Evaluation of severe or refractory gastroesophageal reflux disease or chest pain thought to be due to reflux * Gastrointestinal bleeding PATIENT CHARACTERISTICS: * Not pregnant PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

Measure	Time frame
Polymorphisms in detoxifying enzyme systems such as glutathione S-transferases (e.g., mu, theta, pi)	2000-2013
Polymorphisms in other xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4/5, NQO1, mEH, NAT-2)	2000-2013
Polymorphisms in inflammatory gene pathways (e.g., MPO, MnSOD, IGF, IGFBF3, Il1-beta)	2000-2013
Polymorphisms in DNA repair genes or the p53 pathways (e.g., ERCC2, XRCC1, p53, p73, CCND1, p21)	2000-2013

Countries

United States

Outcome results