Trial Information

Evaluation of the Survivin Urine mRNA Assay to Estimate Risk of Bladder Cancer Found on Cystoscopy

Bladder cancer is the fourth most common cancer in men and ninth most common cancer in
women, accounting for more than 60,000 new cases and ~12,000 deaths in North America in
2004. Cystoscopy and urinary cytology is the standard of care for detection of bladder
cancer, but cystoscopy is expensive and invasive, while cytology has low sensitivity. New,
noninvasive, diagnostic tools for bladder cancer detection have been developed, but their
application in clinical practice has been limited due to low sensitivity and specificity of
the assays. Survivin, an anti-apoptotic protein, is capable of regulating both cell
proliferation and apoptotic cell death, and is over-expressed in most human cancers but not
in normal adult tissues. The purpose of this clinical trial is to evaluate the ability of
urinary Survivin mRNA measurement to estimate the risk of bladder cancer at the time of
cystoscopy in subjects with no prior history of bladder cancer presenting with microscopic
or macroscopic hematuria.

This study is designed to be a prospective, multicenter, double blind, clinical study in
subjects >50 years old with no prior history of bladder cancer and confirmed hematuria
(microscopic and/or macroscopic) presenting to a urologist.

The primary objective of the study is to estimate the risk of bladder cancer at the time of
cystoscopy in subjects >50 years old with no prior history of bladder cancer and confirmed
hematuria using urinary Survivin mRNA levels.

The secondary objective of the study is for comparison of a multivariate predictive
algorithm using urinary Survivin mRNA levels and subject risk factors, such as age, sex,
race, and smoking history, for estimation of the risk of bladder cancer at the time of
cystoscopy in subjects >50 years old with no prior history of bladder cancer and confirmed
hematuria to the use of urinary Survivin mRNA levels alone.