Stage II Bladder Urothelial Carcinoma Clinical Trial
Official title:
Ultrasound and Biomarker Tests of Bladder Cancer Invasiveness
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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