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

Study Overview
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Brief Summary
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This pilot research trial studies how well myeloid derived suppressor cells (MDSC) clinical assay works in finding and monitoring cancer cells in blood and urine samples from patients with or without localized or metastatic bladder cancer. Studying samples of blood and urine from patients with or without bladder cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and may help doctors improve ways to diagnose and treat patients.

Detailed Description
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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.

Official Title
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MDSC Clinical Assay for Cancer Detection and Monitoring in Bladder Carcinoma

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

Intervention / Treatment
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* Other: Cytology Specimen Collection Procedure
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>Patients without cancer undergo collection of blood and urine samples for analysis via MDSC clinical assay at baseline, 1 week, and 4 months. | Other: Cytology Specimen Collection Procedure<br>* Undergo collection of blood and urine samples<br>* Other names: Cytologic Sampling;Other: Laboratory Biomarker Analysis<br>* Samples undergo MDSC clinical assay<br>|
| Group II<br>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. | Other: Cytology Specimen Collection Procedure<br>* Undergo collection of blood and urine samples<br>* Other names: Cytologic Sampling;Other: Laboratory Biomarker Analysis<br>* Samples undergo MDSC clinical assay<br>|
| Group III<br>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. | Other: Cytology Specimen Collection Procedure<br>* Undergo collection of blood and urine samples<br>* Other names: Cytologic Sampling;Other: Laboratory Biomarker Analysis<br>* Samples undergo MDSC clinical assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MDSC level in patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment |  | Baseline to up to 4 months | 
| Change in MDSC level in patients with known metastatic bladder cancer who undergo systemic treatment | The direction and magnitude of the changes in Group 3 will be compared to the changes in tumor burden assessed radiographically - to explore the associations. | Baseline to up to 6 months | 
| Change in MDSC level in patients with no history of cancer |  | Baseline to 4 months | 
| Change in tumor burden evaluated by radiographic imaging |  | Baseline to up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine cytology analysis | The MDSC levels at baseline will be compared (plots and correlations) to the urine cytology levels (Groups 2 and 3) to describe any associations; for Group 3, the changes (baseline to post treatment) in the MDSC levels will be compared to the changes in urine cytology. | Baseline to up to 4 months |