A Diagnostic for the Early Detection of Bladder Cancer

Inclusion Criteria:

Participants must be:

1. Age 50 years or older

2. >20 pack year history of tobacco exposure

3. Free of any malignancy except for the following: adequately treated basal cell orsquamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or IIcancer from which the patient is currently in complete remission, or any othercancer from which the patient has been disease free for five years. Patients withlocalized prostate cancer who are being followed by an active surveillance programare also eligible.

4. Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer ScreeningClinic

5. Willing and able to give written informed consent

6. Willing to provide voided urine sample

7. Be able and willing to complete semi-annual research clinic visits for 4 years

Exclusion Criteria:

Participants must not have:

1. History of hematuria (microscopic or gross) within 2 years of signing consent.

2. Previous history of bladder cancer

3. A known active urinary tract infection or urinary retention

4. An active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwiserepeat.

5. An ureteral stents, nephrostomy tubes or bowel interposition

6. A recent genitourinary instrumentation (within 7 days prior to collection of voidedurine sample)