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

Precancerous Condition Clinical Trial

Official title:

Molecular Epidemiology of Barrett's Esophagus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445653
• Other study ID #: CDR0000450146
• Secondary ID: MGH-1999-P-01092
• Status: Completed
• Phase: N/A
• First received: March 7, 2007
• Last updated: January 13, 2017
• Start date: August 2005
• Est. completion date: March 2013

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Gastroesophageal Reflux
• Precancerous Condition
• Precancerous Conditions

Locations

Country	Name	City	State
United States	Harvard School of Public Health	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polymorphisms in detoxifying enzyme systems such as glutathione S-transferases (e.g., mu, theta, pi)		2000-2013
Primary	Polymorphisms in other xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4/5, NQO1, mEH, NAT-2)		2000-2013
Primary	Polymorphisms in inflammatory gene pathways (e.g., MPO, MnSOD, IGF, IGFBF3, Il1-beta)		2000-2013
Primary	Polymorphisms in DNA repair genes or the p53 pathways (e.g., ERCC2, XRCC1, p53, p73, CCND1, p21)		2000-2013