Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer

  • STATUS
    Recruiting
  • End date
    Sep 8, 2023
  • participants needed
    63
  • sponsor
    University of Southern California
Updated on 25 November 2021
ct scan
cancer
systemic therapy
carcinoma
MRI
neutrophil count
suppressor
kidney cancer
nephrectomy
metastatic renal cell carcinoma
Accepts healthy volunteers

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
Treatment laboratory biomarker analysis, computed tomography, magnetic resonance imaging, cytology specimen collection procedure
Clinical Study IdentifierNCT02664883
SponsorUniversity of Southern California
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

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
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