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

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

Purpose: 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.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02664883

Sponsor: University of Southern California

Primary Outcome Measures:

Measure: 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
Safety Issue:
Measure: Change in MDSC level in patients with localized renal cell carcinoma who undergo nephrectomy
Time Frame: Baseline to 30 days after nephrectomy
Safety Issue:
Measure: Mean MDSC level
Time Frame: Baseline
Safety Issue:

Estimated Enrollment: 63

Study Start Date: September 8, 2015

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Eligibility:

Age: minimum 25 Years maximum N/A
Gender: All

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

Contact:

Charis Barg, RN
323-865-0464

Location:

USC / Norris Comprehensive Cancer Center
Los Angeles California 90033 United States

View trial on ClinicalTrials.gov