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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Christopher Christiani, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00445653
First received: March 7, 2007
Last updated: September 30, 2015
Last verified: September 2015
  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
Precancerous Condition

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Molecular Epidemiology of Barrett's Esophagus

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Polymorphisms in detoxifying enzyme systems such as glutathione S-transferases (e.g., mu, theta, pi) [ Time Frame: 2000-2013 ] [ Designated as safety issue: No ]
  • Polymorphisms in other xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4/5, NQO1, mEH, NAT-2) [ Time Frame: 200-2013 ] [ Designated as safety issue: No ]
  • Polymorphisms in inflammatory gene pathways (e.g., MPO, MnSOD, IGF, IGFBF3, Il1-beta) [ Time Frame: 2000-2013 ] [ Designated as safety issue: No ]
  • Polymorphisms in DNA repair genes or the p53 pathways (e.g., ERCC2, XRCC1, p53, p73, CCND1, p21) [ Time Frame: 2000-2013 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood samples only were collected

Enrollment: 170
Study Start Date: August 2005
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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 to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients coming in for EGD
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445653

Locations
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)
Investigators
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 
Study First Received: March 7, 2007
Last Updated: September 30, 2015
Health Authority: United States: Federal Government

Keywords provided by 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
Neoplasms

ClinicalTrials.gov processed this record on August 25, 2016