Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer

• ClinicalTrials.gov Identifier: NCT02664883
• Recruitment Status: Active, not recruiting
• First Posted: January 27, 2016
• Last Update Posted: November 15, 2022
• Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Southern California

Tracking Information

• First Submitted Date: January 22, 2016
• First Posted Date: January 27, 2016
• Last Update Posted Date: November 15, 2022
• Actual Study Start Date: September 8, 2015
• Actual Primary Completion Date: April 13, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 22, 2016)

• Change in MDSC level in patients with known metastatic renal cell carcinoma who undergo systemic treatment [ Time Frame: Baseline to after 4 months of systemic treatment ]
  The change in MDSC level in patients with known metastatic renal cell carcinoma who undergo systemic treatment will be determined. These changes will be compared to the changes in tumor burden as evaluated by CT scan or other imaging modality.
• Change in MDSC level in patients with localized renal cell carcinoma who undergo nephrectomy [ Time Frame: Baseline to 30 days after nephrectomy ]
• Mean MDSC level [ Time Frame: Baseline ]
  The mean MDSC level, intra-subject variability, and inter-subject variability for three groups of subjects with variable renal cell carcinoma disease status will be determined at baseline.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer
• Official Title: MDSC Clinical Assay for Cancer Detection and Monitoring in Renal Cell Carcinoma
• Brief Summary: This pilot research trial studies the use of the Myeloid Derived Suppressor Cells Clinical Assay in finding and monitoring kidney cancer. Studying samples of blood and urine from patients with kidney cancer in the laboratory may aid doctors in the early detection of cancer, monitor tumor response to therapy, detect the presence of occult spreading of disease, and identify early return of disease.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate a novel clinical assay (Myeloid Derived Suppressor Cells [MDSC] Clinical Assay) to detect cancer associated immune cells in the peripheral blood of patients as a means to better detect and monitor malignant renal cell carcinoma in patients.

II. Determine mean MDSC level, intra-subject variability, and inter-subject variability for three groups of subjects with variable renal cell carcinoma disease status at baseline.

III. In patients with known localized renal cell carcinoma who undergo nephrectomy, determine the change in MDSC level from diagnosis to after nephrectomy.

IV. In patients with known metastatic renal cell carcinoma who undergo systemic treatment, determine the change in MDSC level from baseline to after treatment (4 months) and, secondarily, to compare these changes to the changes in tumor burden as evaluated by computed tomography (CT) scan or other imaging modality.

OUTLINE: Patients are assigned to 1 of 3 groups according to disease status.

GROUP I: Patients with no evidence of cancer and no hematuria undergo collection of blood and urine samples at baseline and 2 months for analysis via the Flow Cytometry MDSC Clinical Assay.

GROUP II: Patients diagnosed with localized renal cell carcinoma undergo collection of blood and urine samples at baseline and after nephrectomy for analysis via the Flow Cytometry MDSC Clinical Assay. Patients also undergo CT or magnetic resonance imaging (MRI) within 30 days after nephrectomy.

GROUP III: Patients diagnosed with metastatic renal cell carcinoma undergo collection of samples prior to baseline and then after 4 months of systemic treatment for analysis via the Flow Cytometry MDSC Clinical Assay. Patients also undergo CT or MRI after completion of 4 months of systemic treatment.

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood and urine samples

• Sampling Method: Non-Probability Sample
• Study Population: Patients with renal cell carcinoma and their accompanying partners who are seen at the Urologic Oncology and Medical Oncology Clinics of the Keck Medical Center of University Southern California (USC), Norris Cancer Center, and USC-Los Angeles County Hospital will be recruited for this trial.

Condition

• Healthy Subject
• Metastatic Renal Cell Cancer
• Recurrent Renal Cell Carcinoma
• Stage I Renal Cell Cancer
• Stage II Renal Cell Cancer
• Stage III Renal Cell Cancer

Intervention

• Procedure: Computed Tomography
  Correlative studies
  Other Names:

  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
• Other: Cytology Specimen Collection Procedure
  Undergo collection of blood and urine samples
  Other Name: Cytologic Sampling
• Other: Laboratory Biomarker Analysis
  Correlative studies
• Procedure: Magnetic Resonance Imaging
  Correlative studies
  Other Names:

  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Study Groups/Cohorts

• Group I (no cancer or hematuria)
  Patients with no evidence of cancer and no hematuria undergo collection of blood and urine samples at baseline and 2 months for analysis via the Flow Cytometry MDSC Clinical Assay
  Interventions:

  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
• Group II (localized RCC)
  Patients diagnosed with localized renal cell carcinoma undergo collection of blood and urine samples at baseline and after nephrectomy for analysis via the Flow Cytometry MDSC Clinical Assay. Patients also undergo CT or MRI within 30 days after nephrectomy.
  Interventions:

  • Procedure: Computed Tomography
  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
  • Procedure: Magnetic Resonance Imaging
• Group III (metastatic RCC)
  Patients diagnosed with metastatic renal cell carcinoma undergo collection of samples prior to baseline and then after 4 months of systemic treatment for analysis via the Flow Cytometry MDSC Clinical Assay. Patients also undergo CT or MRI after completion of 4 months of systemic treatment.
  Interventions:

  • Procedure: Computed Tomography
  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
  • Procedure: Magnetic Resonance Imaging

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 12, 2022): 37
• Original Estimated Enrollment (submitted: January 22, 2016): 63
• Estimated Study Completion Date: September 8, 2023
• Actual Primary Completion Date: April 13, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subjects enrolled in this study must meet one of the 3 following criteria:

  • Group 1: Healthy individual with no history of cancer or hematuria
  • Group 2: Subject with a diagnosis of localized renal cell carcinoma (by imaging and eventual pathology) scheduled to undergo nephrectomy
  • Group 3: Subject with a diagnosis of metastatic renal cell cancer(by imaging and eventual pathology) who is scheduled to begin a new systemic therapy
• Any type of renal cell carcinoma (RCC); any prior therapy
• Performance status: 0-3
• Leukocytes >= 3,000/mcL (frequently used - numbers listed are examples, investigator should modify as needed)
• Absolute neutrophil count >= 1,500/mcL (frequently used - numbers listed are examples, investigator should modify as needed)
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• For normal subject arm: no evidence of cancer or hematuria
• For localized RCC arm: no 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 RCC arm: no evidence of 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 all subjects: uncontrolled intercurrent illness including, but not limited to previous or current history of second malignancy unrelated to renal cell carcinoma; 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02664883
• Other Study ID Numbers: 4K-14-4; NCI-2015-01559 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); HS-15-00309; 4K-14-4 ( Other Identifier: USC / Norris Comprehensive Cancer Center ); P30CA014089 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Southern California
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Southern California
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jacek Pinski, MD; University of Southern California

• PRS Account: University of Southern California
• Verification Date: November 2022