Ultrasound and Biomarker Tests in Predicting Cancer Aggressiveness in Tissue Samples of Patients With Bladder Cancer
Ultrasound and Biomarker Tests in Predicting Cancer Aggressiveness in Tissue Samples of Patients With Bladder Cancer
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).
Inclusion Criteria:

 -  Patients with a confirmed diagnosis of UCC, having one of the stages (Ta, Tis, T1, and
 T2 or higher)

 -  Patients with UCC who are undergoing a standard procedure to remove cells/tissue from
 their bladders (cystoscopy, biopsy, or surgery)

 -  Ability to understand and the willingness to sign a written informed consent

 Exclusion Criteria:

 -  Patients who have had chemotherapy, radiotherapy, or immunotherapy within 4 weeks
 prior to entering the study or those who have not recovered from adverse events due to
 agents administered more than 4 weeks earlier