Overview

This trial has been completed.

Condition precancerous condition
Sponsor Massachusetts General Hospital
Collaborator National Cancer Institute (NCI)
Start date August 2005
End date March 2013
Trial size 170 participants
Trial identifier NCT00445653, CDR0000450146, MGH-1999-P-010929/13

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

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

Eligibility Criteria

All participants from 18 years up to 90 years old.

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

Additional Information

Official title Molecular Epidemiology of Barrett's Esophagus
Principal investigator David C. Christiani, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.