MDSC Clinical Assay in Finding and Monitoring Cancer Cells in Blood and Urine Samples From Patients with or without Localized or Metastatic Bladder Cancer
- 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
- 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
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.
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.
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.
Trial Phase Phase NA
Trial Type Ancillary-correlative
USC / Norris Comprehensive Cancer Center
- Primary ID 4B-15-2
- Secondary IDs NCI-2016-00265
- Clinicaltrials.gov ID NCT02735512