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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
This study is ongoing, but not recruiting participants.
Study NCT00445653   Information provided by National Cancer Institute (NCI)
First Received: March 7, 2007   Last Updated: May 9, 2009   History of Changes

March 7, 2007
May 9, 2009
August 2005
 
  • 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)
Same as current
Complete list of historical versions of study NCT00445653 on ClinicalTrials.gov Archive Site
 
 
 
DNA Changes as a Risk Factor for Barrett's Esophagus in Patients With Barrett's Esophagus, Gastroesophageal Reflux, or Gastrointestinal Bleeding
Molecular Epidemiology of Barrett's Esophagus

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.

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.

 
Observational
 
Precancerous/Nonmalignant 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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
350
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00445653
 
CDR0000450146, MGH-1999-P-010929/13
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: David C. Christiani, MD Massachusetts General Hospital
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP