Digital Image Analysis and Fluorescent In Situ Hybridization in Predicting Development of Esophageal Cancer in Patients With Barrett Esophagus - NCT00629109-55905 (Clinical Trial 206906)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy206906.aspx
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| City: |
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Rochester |
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State:
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MN |
| Zip Code: |
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55905 |
| Conditions: |
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Esophageal Cancer - Precancerous Condition |
| Purpose: |
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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.
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| Study summary: |
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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: |
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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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| Study is available at: |
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Mayo Clinic Cancer Center
Rochester, MN 55905
United States
Primary Contact:
Clinical Trials Office - All Mayo Clinic Locations
Phone: 507-538-7623 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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