MDSC Clinical Assay in Finding and Monitoring Cancer Cells in Blood and Urine Samples From Patients With or Without Localized or Metastatic Bladder Cancer

PRIMARY OBJECTIVES:

I. To evaluate a novel clinical assay (MDSC clinical assay) to detect cancer associated
immune cells in the peripheral blood of patients as a means to better detect and monitor
malignant bladder cancer in patients.

II. Estimate mean MDSC level, intra-patient variability, and inter-patient variability, for 3
groups of subjects with variable bladder cancer disease status at baseline.

III. In patients with known localized, muscle-invasive bladder cancer who undergo surgical
treatment: to determine the change in MDSC level from baseline to after treatment including
surgery.

IV. In patients with known metastatic bladder cancer who undergo systemic treatment: to
determine the change in MDSC level from baseline to after 4 cycles of treatment compared to
the change in tumor burden as evaluated by radiographic imaging.

V. In patients with no history of cancer: to determine the changes in MDSC levels from
baseline to after 4 months.

SECONDARY OBJECTIVES:

I. Compare MDSC level measurements to urine cytology analysis at baseline and after treatment
to determine whether the two tests correlate in any of the 3 groups of patients defined in
this study.

OUTLINE:

GROUP I: Patients without cancer undergo collection of blood and urine samples for analysis
via MDSC clinical assay at baseline, 1 week, and 4 months.

GROUP II: Patients with localized bladder cancer undergo collection of blood and urine
samples for analysis via MDSC clinical assay at baseline, 1 week, and within 4 weeks after
cystectomy.

GROUP III: Patients with metastatic cancer undergo collection of blood and urine samples for
analysis via MDSC clinical assay at baseline, 1 week, and within 4 weeks after completion of
4 courses of systemic chemotherapy.

Inclusion Criteria:

- Subjects must meet the criteria for one of the three following groups:

- Normal patients- aged 40 years and older with no evidence of hematuria or cancer

- Patients with localized bladder cancer diagnosed by cystoscopy and pathology:
T2N0M0 or T3N0M0 who have not received neoadjuvant chemotherapy

- Patients with metastatic bladder cancer: newly diagnosed with no previous
treatment for metastatic disease

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

Exclusion Criteria:

- For normal subject arm: evidence of cancer or hematuria

- For localized bladder cancer: evidence of metastatic disease, second cancer, prior
chemotherapy or radiotherapy 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

- For metastatic bladder cancer: prior therapy for metastatic disease

- Uncontrolled intercurrent illness including, but not limited to previous or current
history of second malignancy unrelated to bladder cancer; autoimmune disease or immune
deficiency, chronic treatment with immunomodulatory therapies (e.g. glucocorticoids);
significant trauma, surgery, or infection in the past two weeks or psychiatric
illness/social situations that would limit compliance with study requirements