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

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