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Biomarkers in Finding Barrett's Esophagus in Patients With Barrett's Esophagus or Other Conditions - NCT00899106-20889(Clinical Trial 291394)



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City:  Bethesda
State:  
MD
Zip Code: 20889
Conditions: Anemia - Dysphagia - Esophageal Cancer - Gastrointestinal Complications - Precancerous/Nonmalignant Condition
Purpose: RATIONALE: Studying samples of tissue from patients with Barrett's esophagus or other conditions in the laboratory may help doctors identify and learn more about biomarkers related to Barrett's esophagus. It may also help doctors find Barrett's esophagus earlier. PURPOSE: This laboratory study is looking at biomarkers in finding Barrett's esophagus in patients with Barrett's esophagus or other conditions.
Study summary: OBJECTIVES: Primary - Identify a blood-based biomarker to be used in screening patients for Barrett's esophagus (BE). - Determine the ability to predict BE status from serum proteomic patterns. Secondary - Compare esophageal tissue DNA alterations, RNA expression, and proteomic profiles in patients with BE vs other conditions. - Compare germ line polymorphism profiles in patients with BE vs other conditions. - Compare blood and tissue biomarkers in non-BE patients with vs without gastroesophageal reflux disease. Tertiary - Identify biomarkers in blood or tissue that predict which patients with BE are most likely to progress to dysplasia or esophageal adenocarcinoma. OUTLINE: Patients are assigned to 1 of 2 groups. - Group 1 (Barrett's esophagus [BE]): Patients undergo routine upper gastrointestinal endoscopic biopsy of several small pieces of tissue from the esophagus and a single brushing of surface esophageal cells. - Group 2 (other conditions): Patients undergo routine endoscopic biopsy of normal-appearing areas near the top of the esophagus and stomach. Four additional biopsies and a single brushing of the surface esophageal cells are performed. In both groups, samples are analyzed for their genetic materials (DNA and RNA) and proteins. Genetic materials are only used to test for potential markers of cancer-susceptibility, pre-cancer, or cancer. Quality of life is assessed at baseline. Patients are followed every 3 years. PROJECTED ACCRUAL: A total of 800 patients (200 with Barrett's esophagus [BE] and 600 with other conditions) will be accrued for this study within 18 months.
Criteria: DISEASE CHARACTERISTICS: - One of the following conditions: - Gastroesophageal reflux disease (GERD) OR GERD-like symptoms - Barrett's esophagus - Dysphagia - Anemia - Gastrointestinal bleeding - Presence of another condition (e.g., dyspepsia) that merit endoscopic evaluation PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No severe cardiac disease Pulmonary - No severe pulmonary disease Other - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
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Data Source: ClinicalTrials.gov
Date Processed: December 30, 2009
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