MDSC Clinical Assay for Cancer Detection and Monitoring in Bladder Carcinoma

Condition: No Evidence of Disease, Stage II Bladder Cancer, Stage III Bladder Cancer, Stage IVA Bladder Cancer, Stage IVB Bladder Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02735512

Sponsor: University of Southern California



  • Age: minimum N/A maximum N/A
  • Gender: All

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

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