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| Tracking Information | |||||
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| First Received Date ICMJE | March 7, 2007 | ||||
| Last Updated Date | May 9, 2009 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00445653 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | DNA Changes as a Risk Factor for Barrett's Esophagus in Patients With Barrett's Esophagus, Gastroesophageal Reflux, or Gastrointestinal Bleeding | ||||
| Official Title ICMJE | Molecular Epidemiology of Barrett's Esophagus | ||||
| Brief 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. |
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| Detailed Description | 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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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE | Precancerous/Nonmalignant Condition | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 350 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00445653 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000450146, MGH-1999-P-010929/13 | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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