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DNA Changes as a Risk Factor for Barrett's Esophagus in Patients With Barrett's Esophagus, Gastroesophageal Reflux, or Gastrointestinal Bleeding

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00445653
First received: March 7, 2007
Last updated: February 1, 2010
Last verified: May 2007
History of Changes
  Purpose

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 Intervention
Precancerous Condition
 Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Other: physiologic testing
Other: study of socioeconomic and demographic variables
Procedure: study of high risk factors

Study Type: Observational
Official Title: Molecular Epidemiology of Barrett's Esophagus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 350
Study Start Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445653

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

No publications provided

ClinicalTrials.gov Identifier: NCT00445653     History of Changes
Other Study ID Numbers: CDR0000450146, MGH-1999-P-010929/13
Study First Received: March 7, 2007
Last Updated: February 1, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Barrett esophagus

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

ClinicalTrials.gov processed this record on May 16, 2013