Precancerous Condition Clinical Trial
Official title:
Molecular Epidemiology of Barrett's Esophagus
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.
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.
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