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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00445653
Collaborator
National Cancer Institute (NCI) (NIH)
170
Enrollment
2
Locations
91
Duration (Months)
85
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    170 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Molecular Epidemiology of Barrett's Esophagus
    Study Start Date :
    Aug 1, 2005
    Actual Primary Completion Date :
    Mar 1, 2013
    Actual Study Completion Date :
    Mar 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Polymorphisms in detoxifying enzyme systems such as glutathione S-transferases (e.g., mu, theta, pi) [2000-2013]

    2. Polymorphisms in other xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4/5, NQO1, mEH, NAT-2) [2000-2013]

    3. Polymorphisms in inflammatory gene pathways (e.g., MPO, MnSOD, IGF, IGFBF3, Il1-beta) [2000-2013]

    4. Polymorphisms in DNA repair genes or the p53 pathways (e.g., ERCC2, XRCC1, p53, p73, CCND1, p21) [2000-2013]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    2 Harvard School of Public Health Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: David C. Christiani, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Christopher Christiani, Pulmonary Associate, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT00445653
    Other Study ID Numbers:
    • CDR0000450146
    • MGH-1999-P-010929/13
    First Posted:
    Mar 9, 2007
    Last Update Posted:
    Jan 18, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by David Christopher Christiani, Pulmonary Associate, Massachusetts General Hospital
    Barrett esophagus
    Additional relevant MeSH terms:
    Barrett Esophagus
    Precancerous Conditions

    Study Results

    No Results Posted as of Jan 18, 2017