MDSC Clinical Assay in Finding and Monitoring Cancer Cells in Blood and Urine Samples From Patients With or Without Localized or Metastatic Bladder Cancer
NCT ID: NCT02735512
Last Updated: 2022-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
10 participants
OBSERVATIONAL
2016-03-01
2022-04-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Cytology Specimen Collection Procedure
Undergo collection of blood and urine samples
Laboratory Biomarker Analysis
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.
Cytology Specimen Collection Procedure
Undergo collection of blood and urine samples
Laboratory Biomarker Analysis
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.
Cytology Specimen Collection Procedure
Undergo collection of blood and urine samples
Laboratory Biomarker Analysis
Samples undergo MDSC clinical assay
Interventions
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Cytology Specimen Collection Procedure
Undergo collection of blood and urine samples
Laboratory Biomarker Analysis
Samples undergo MDSC clinical assay
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Jacek Pinski
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2016-00265
Identifier Type: REGISTRY
Identifier Source: secondary_id
4B-15-2
Identifier Type: OTHER
Identifier Source: secondary_id
4B-15-2
Identifier Type: -
Identifier Source: org_study_id
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