Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • 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
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 25 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT02664883
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jacek Pinski, MD University of Southern California