Screening for Bladder Cancer

Reduction of cancer mortality is a stated goal of the National Cancer Institute. Cancer of
the bladder is the 4th most commonly diagnosed cancer and 7th leading cause of cancer death
in the American men, and represents an important target for mortality-reducing efforts.
Furthermore, these tumors, even in early (i.e. curable) stages, usually cause several easily
detectable abnormalities, including hematuria, and the presence of abnormal tumor products
that are shed into urine or lie within exfoliated malignant cells.

The overall goal of the proposed study is to gain information concerning the performance
characteristics of three bladder cancer markers when combined with hematuria testing in
detecting bladder cancer.

A mail back questionnaire, completed at the beginning of the study, will provide information
about the participants and the results of testings will be reported after each testing
period. Individuals with even a solitary positive test will undergo a thorough urologic
evaluation to determine the cause of hematuria and follow-up will continue or 2 years after
completion of the study. At the time of the evaluation, three bladder cancer marker tests,
NMP22 Bladder Chek, ImmunoCyt and UroVysion FISH will be performed, but regardless of the
results, a hematuria evaluation will be completed. Data will be updated continually.

The 10 day testing with Hemastix will be repeated 9 months after the first one is completed
regardless of the outcome of the first testing.

Inclusion Criteria:

- Men age 60 and over, - who are current cigarette smokers OR - who have a history of
at least 20 pack years smoking OR - who have over a 30 pack/year history who have
stopped smoking within 10 years of the registration date OR - who have a 40 pack year
history of smoking regardless of the quit date, will be eligible for participation.

- Patients with prostate or renal cancer must have been treated more than 5 years
previously and be considered disease-free at the time of entry. In the case of
prostate cancer, patients may have only received prostatectomy as their treatment and
must have undetectable PSA's at study entry.

- In the case of calculus disease, patients must be believed to be stone free at time
of study entry and could not have had a stone attack within the previous 2 years.

- Patients receiving anticoagulation therapy, such as Warfarin, Plavix, Lovenox,
aspirin, etc. will be able to take part in the study and, will be thoroughly
worked-up if the only explainable cause of hematuria is receiving anticoagulation
medication.

Exclusion Criteria:

- history of urothelial cancer

- any malignancy other than non-melanoma skin cancers treated within the past 5 years

- benign tumors of the urinary tract that are still existent

- known urinary calculi

- medical or oncological conditions known to produce hematuria (e.g.
glomerulonephritis, treatments with cyclophosphamide, methotrexate and pelvic
radiation therapy)

- visual, psychological, neurological, musculoskeletal, etc. impairments that would
make home testing impractical