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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00445653 |
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/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 |
| Study Type: | Observational |
| Official Title: | Molecular Epidemiology of Barrett's Esophagus |
| Estimated Enrollment: | 350 |
| Study Start Date: | August 2005 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Undergoing elective esophagogastroduodenoscopy for any of the following reasons:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Massachusetts | |
| Harvard School of Public Health | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | David C. Christiani, MD | Massachusetts General Hospital |
More Information
| Study ID Numbers: | CDR0000450146, MGH-1999-P-010929/13 |
| Study First Received: | March 7, 2007 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00445653 History of Changes |
| Health Authority: | United States: Federal Government |
|
Barrett esophagus |
|
Precancerous Conditions Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Neoplasms Digestive System Abnormalities Digestive System Diseases Pathologic Processes Barrett Esophagus Esophageal Diseases |