Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer
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- STATUS
- Recruiting
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- End date
- Sep 8, 2023
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- participants needed
- 63
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- sponsor
- University of Southern California
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.
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.
Details
| Condition | Metastatic Kidney Cancer, Skin Wounds, Injection Port, Vaginal Atrophy, Metastatic Renal Cell Carcinoma, Adverse Effects, Drugs, Recurrent Respiratory Papillomatosis, Healthy Subject, Stage I Renal Cell Cancer, Diet and Nutrition, Razor Bumps (Pseudofolliculitis Barbae), Stage II Renal Cell Cancer, Brain Function, Breast Cancer - HER2 Positive, Pediatric Health, Anal Dysplasia, Primary Immunodeficiency, Chronic Diarrhea, Stage III Renal Cell Cancer, Chronic Shoulder Pain, Metastatic Renal Cell Cancer, Recurrent Renal Cell Carcinoma, Peripheral Arterial Occlusive Disease, Near-Sighted Corrective Surgery, Metastatic Triple-Negative Breast Cancer |
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| Treatment | laboratory biomarker analysis, computed tomography, magnetic resonance imaging, cytology specimen collection procedure |
| Clinical Study Identifier | NCT02664883 |
| Sponsor | University of Southern California |
| Last Modified on | 25 November 2021 |
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