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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00862 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HS-15-00245 | |||
| 4B-15-5 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source | |
| P41EB002182 | U.S. NIH Grant/Contract | View source |
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The PI left institution
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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This research trial studies two types of tests, an ultrasound test and a biomarker test, to see how well they predict how aggressive (invasive) bladder cancer is in samples from patients with bladder cancer. The aggressiveness of a tumor means how likely it is to invade the body and spread. The ultrasound test uses a fluorescent dye and stimulates cells under a microscope to see how they respond. This may allow doctors to predict how likely the cancer cells are to spread in the body. The biomarker test uses laboratory testing of samples from patients to study genes and other molecules that may predict the cancer invasiveness. Comparing two different ways of predicting cancer aggressiveness may help doctors identify how well they work, and may eventually allow doctors to predict aggressiveness without needing to take a biopsy.
PRIMARY OBJECTIVES:
I. To establish an association between bladder cancer disease stage and the level of invasiveness as measured by a novel ultrasound assay.
II. To establish an association between bladder cancer disease stage and expression of novel invasiveness biomarkers related to the RE1-silencing transcription factor (REST) gene.
OUTLINE:
Previously collected tumor tissue samples, bladder washings, and urine cells are stained with calcium dye, washed and immersed in external buffer solution, and then transferred to the ultrasound imaging system. Tissue, bladder wash cells and urine cells samples are also analyzed for biomarkers of invasiveness derived from or related to REST gene via quantitative reverse transcriptase polymerase chain reaction (qRT-PCR), Western blot, and fluorescence in situ hybridization (FISH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (ultrasound, biomarker studies) | Previously collected tumor tissue samples, bladder washings, and urine cells are stained with calcium dye, washed and immersed in external buffer solution, and then transferred to the ultrasound imaging system. Tissue, bladder wash cells and urine cells samples are also analyzed for biomarkers of invasiveness derived from or related to REST gene via qRT-PCR, Western blot, and FISH. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Biomarker analysis |
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| Measure | Description | Time Frame |
|---|---|---|
| Observed change in fluorescence of responding cells using the cell response index (CRI) | Data will be post-processed to determine the level of ultrasound-induced calcium response at each stimulus amplitude. Cell locations will be identified with CellProfiler image analysis software and used to extract the raw fluorescence intensities for each cell. CRI will be plotted against stimulus amplitude, a sigmoid will be fit to the curve, and threshold will be defined as the amplitude that yielded a 50% response. | Baseline to up to 30 minutes |
| Observed change in percentage of responding cells using the cell response index (CRI) | Data will be post-processed to determine the level of ultrasound-induced calcium response at each stimulus amplitude. Cell locations will be identified with CellProfiler image analysis software and used to extract the raw fluorescence intensities for each cell. CRI will be plotted against stimulus amplitude, a sigmoid will be fit to the curve, and threshold will be defined as the amplitude that yielded a 50% response. | Baseline to up to 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at the USC/Norris Comprehensive Cancer Center facilities with bladder cancer will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Andres Weitz | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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Tissue, bladder washings, and urine