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Molecular Epidemiology of Barrett's Esophagus


N/A
18 Years
N/A
Open (Enrolling)
Both
Precancerous Condition

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Trial Information

Molecular Epidemiology of Barrett's Esophagus


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Polymorphisms in detoxifying enzyme systems such as glutathione S-transferases (e.g., mu, theta, pi)

Principal Investigator

David C. Christiani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000450146

NCT ID:

NCT00445653

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Precancerous Condition
  • Barrett esophagus
  • Barrett Esophagus
  • Gastroesophageal Reflux
  • Gastrointestinal Hemorrhage
  • Precancerous Conditions

Name

Location

Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Harvard School of Public Health Boston, Massachusetts  02115