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Digital Image Analysis and Fluorescent In Situ Hybridization in Predicting Development of Esophageal Cancer in Patients With Barrett Esophagus - NCT00629109-55905(Clinical Trial 206906)



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City:  Rochester
State:  
MN
Zip Code: 55905
Conditions: Esophageal Cancer - Precancerous Condition
Purpose: RATIONALE: Diagnostic procedures, such as digital image analysis and fluorescent in situ hybridization, may help doctors learn the extent of Barrett esophagus. PURPOSE: This randomized phase II trial is studying how well digital image analysis and fluorescent in situ hybridization predict development of esophageal cancer in patients with Barrett esophagus.
Study summary: OBJECTIVES: - To determine whether fluorescent in situ hybridization (FISH) performed on cytology specimens correlates better than digital image analysis (DIA) with histology from surveillance biopsies in patients with Barrett esophagus. - To determine whether the use of a high-capacity cytology collection device (i.e., a novel ultra-capacity cytology net or a high-capacity brush) affects the results of analysis with either FISH or DIA. OUTLINE: Patients are stratified according to segment length of Barrett esophagus (BE) (≤ 3 cm vs > 3 cm). Patients are randomized to 1 of 3 arms. - Arm I (high-capacity cytology brush): Patients undergo endoscopy to evaluate the BE for segment length, length and presence of islands or tongues of BE, and mucosal abnormalities. Patients then undergo mucus removal from the surface of the esophagus followed by brushings over the entire BE surface area using a high-capacity cytology brush. The BE is then biopsied and if mucosal abnormalities are elevated, the mucosa is resected. - Arm II (low-capacity cytology brush): Patients undergo endoscopy and mucus removal as in arm I and brushings over the entire BE surface area using a low-capacity brush. Patients then undergo biopsy of the BE as in arm I. - Arm III (cytology net): Patients undergo endoscopy and mucus removal as in arm I and brushings over the entire BE surface area using a cytology net. Patients then undergo biopsy of the BE as in arm I. Collected cytology samples are examined by digital image analysis, including quantitative DNA staining, and fluorescent in situ hybridization to probe for c-myc 8q24.12-13, p16 (9p21), HER-2/neu (17q11.2-12), and 20q (20q13). Biopsy tissue samples are analyzed by histopathology. Cytology and biopsy tissue samples are also stored for future studies.
Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed Barrett esophagus (BE) that is endoscopically visible AND meets 1 of the following criteria: - No dysplasia - Any grade of dysplasia present (e.g., indefinite, low-grade, or high-grade) - Early cancer (i.e., < 3 cm in diameter) - Scheduled to undergo endoscopy for surveillance of BE PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - PT (INR) < 2.0 - Hemoglobin > 8.0 g/dL - Able to tolerate endoscopic procedures - Not pregnant or nursing - Negative pregnancy test PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior radiotherapy - More than 6 months since prior chemotherapy, biologic therapy, or surgery
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Data Source: ClinicalTrials.gov
Date Processed: September 9, 2010
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