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

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ClinicalTrials.gov Identifier: NCT02735512
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
No Evidence of Disease Stage II Bladder Cancer Stage III Bladder Cancer Stage IVA Bladder Cancer Stage IVB Bladder Cancer Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis

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 Design
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Study Type : Observational
Estimated Enrollment : 63 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: MDSC Clinical Assay for Cancer Detection and Monitoring in Bladder Carcinoma
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 Other: Cytology Specimen Collection Procedure
Undergo collection of blood and urine samples
Other Name: Cytologic Sampling

Other: 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.
 Other: Cytology Specimen Collection Procedure
Undergo collection of blood and urine samples
Other Name: Cytologic Sampling

Other: 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.
 Other: Cytology Specimen Collection Procedure
Undergo collection of blood and urine samples
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Samples undergo MDSC clinical assay


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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.

  3. Change in MDSC level in patients with no history of cancer [ Time Frame: Baseline to 4 months ]
  4. Change in tumor burden evaluated by radiographic imaging [ Time Frame: Baseline to up to 1 year ]

Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood, urine

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735512


Contacts
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Contact: Cheryl Kefauver, RN 323-865-3000 Cheryl.Kefauver@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Jacek Pinski    323-865-3929    pinski@med.usc.edu   
Principal Investigator: Jacek Pinski         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jacek Pinski University of Southern California
More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02735512     History of Changes
Other Study ID Numbers: 4B-15-2
NCI-2016-00265 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
4B-15-2 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases