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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
Health authority
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

Study Design


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
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