Ultrasound and Biomarker Tests in Predicting Cancer Aggressiveness in Tissue Samples of Patients With Bladder Cancer

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