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BRIEF TITLE: MDSC Clinical Assay for Cancer Detection and Monitoring in Bladder Carcinoma

MDSC Clinical Assay for Cancer Detection and Monitoring in Bladder Carcinoma


  • Org Study ID: 4B-15-2
  • Secondary ID: NCI-2016-00265,4B-15-2,P30CA014089
  • NCT ID: NCT02735512
  • NCT Alias:
  • Sponsor: University of Southern California - Other
  • Source: University of Southern California

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.

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.

Overal Status Start Date Phase Study Type
Recruiting March 1, 2016 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Change in MDSC level in patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment

Primary Outcome 1 - Time Frame: Baseline to up to 4 months

Primary Outcome 2 - Measure: Change in MDSC level in patients with known metastatic bladder cancer who undergo systemic treatment

Primary Outcome 2 - Time Frame: Baseline to up to 6 months

Primary Outcome 3 - Measure: Change in MDSC level in patients with no history of cancer

Primary Outcome 3 - Time Frame: Baseline to 4 months

Primary Outcome 4 - Measure: Change in tumor burden evaluated by radiographic imaging

Primary Outcome 4 - Time Frame: Baseline to up to 1 year

Condition:

  • No Evidence of Disease
  • Stage II Bladder Cancer
  • Stage III Bladder Cancer
  • Stage IVA Bladder Cancer
  • Stage IVB Bladder Cancer

Eligibility

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
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Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Official Information

Name: Jacek Pinski

Role: Principal Investigator

Affiliation: University of Southern California

Overall Contact

Name: Cheryl Kefauver, RN

Phone: 323-865-3000

Email: Cheryl.Kefauver@med.usc.edu

Location

Facility Status Contact
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Jacek Pinski
323-865-3929
pinski@med.usc.edu