MDSC Clinical Assay in Finding and Monitoring Cancer Cells in Blood and Urine Samples From Patients With or Without Localized or Metastatic Bladder Cancer
MDSC Clinical Assay for Cancer Detection and Monitoring in Bladder Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Undergo collection of blood and urine samples
Other Names:
Samples undergo MDSC clinical assay
|
|
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.
|
Undergo collection of blood and urine samples
Other Names:
Samples undergo MDSC clinical assay
|
|
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.
|
Undergo collection of blood and urine samples
Other Names:
Samples undergo MDSC clinical assay
|
What is the study measuring?
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
Time Frame: Baseline to up to 4 months
|
Baseline to up to 4 months
|
|
|
Change in MDSC level in patients with known metastatic bladder cancer who undergo systemic treatment
Time Frame: Baseline to up to 6 months
|
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
Time Frame: Baseline to 4 months
|
Baseline to 4 months
|
|
|
Change in tumor burden evaluated by radiographic imaging
Time Frame: Baseline to up to 1 year
|
Baseline to up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in urine cytology analysis
Time Frame: Baseline to up to 4 months
|
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
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4B-15-2 (OTHER: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2016-00265 (REGISTRY: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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