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| ID | Type | Description | Link |
|---|---|---|---|
| MGH-1999-P-010929/13 | Other Identifier | Partners Healthcare IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Polymorphisms in detoxifying enzyme systems such as glutathione S-transferases (e.g., mu, theta, pi) | 2000-2013 | |
| Polymorphisms in other xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4/5, NQO1, mEH, NAT-2) | 2000-2013 | |
| Polymorphisms in inflammatory gene pathways (e.g., MPO, MnSOD, IGF, IGFBF3, Il1-beta) | 2000-2013 | |
| Polymorphisms in DNA repair genes or the p53 pathways (e.g., ERCC2, XRCC1, p53, p73, CCND1, p21) | 2000-2013 |
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DISEASE CHARACTERISTICS:
Undergoing elective esophagogastroduodenoscopy for any of the following reasons:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Patients coming in for EGD
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| Name | Affiliation | Role |
|---|---|---|
| David C. Christiani, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States | ||
| Harvard School of Public Health |
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| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Blood samples only were collected
| Boston |
| Massachusetts |
| 02115 |
| United States |