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

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ClinicalTrials.gov Identifier: NCT00445653
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : January 18, 2017
Information provided by (Responsible Party):

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
Precancerous Condition

Detailed Description:


  • 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 : August 2005
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

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

Biospecimen Retention:   Samples With DNA
Blood samples only were collected

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients coming in for EGD


  • 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


  • Not pregnant


  • Not specified
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445653

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Harvard School of Public Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: David C. Christiani, MD Massachusetts General Hospital
More Information

Responsible Party: David Christopher Christiani, Pulmonary Associate, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00445653     History of Changes
Other Study ID Numbers: CDR0000450146
MGH-1999-P-010929/13 ( Other Identifier: Partners Healthcare IRB )
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David Christopher Christiani, Massachusetts General Hospital:
Barrett esophagus

Additional relevant MeSH terms:
Gastroesophageal Reflux
Barrett Esophagus
Precancerous Conditions
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Digestive System Abnormalities