NCT02664883

Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer

MDSC Clinical Assay for Cancer Detection and Monitoring in Renal Cell Carcinoma

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Correlative studies
OTHER	Cytology Specimen Collection Procedure	Undergo collection of blood and urine samples
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Magnetic Resonance Imaging	Correlative studies

Timeline

• Start date: 2015-09-08
• Primary completion: 2022-04-13
• Completion: 2026-10-29
• First posted: 2016-01-27
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States