Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer

NCT02664883 | Active Not Recruiting DMC

• 4 other identifiers: 4K-14-4NCI-2015-01559HS-15-00309P30CA014089
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• Change in MDSC level in patients with known metastatic renal cell carcinoma who undergo systemic treatment

  The change in MDSC level in patients with known metastatic renal cell carcinoma who undergo systemic treatment will be determined. These changes will be compared to the changes in tumor burden as evaluated by CT scan or other imaging modality.

  Baseline to after 4 months of systemic treatment

• Change in MDSC level in patients with localized renal cell carcinoma who undergo nephrectomy

  Baseline to 30 days after nephrectomy

• Mean MDSC level

  The mean MDSC level, intra-subject variability, and inter-subject variability for three groups of subjects with variable renal cell carcinoma disease status will be determined at baseline.

  Baseline

Study Arms (3)

Group I (no cancer or hematuria)

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

Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Group II (localized RCC)

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 MRI within 30 days after nephrectomy.

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

Group III (metastatic RCC)

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.

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

Interventions

Computed Tomography PROCEDURE

Correlative studies

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

Group II (localized RCC); Group III (metastatic RCC)

Cytology Specimen Collection Procedure OTHER

Undergo collection of blood and urine samples

Also known as: Cytologic Sampling

Group I (no cancer or hematuria); Group II (localized RCC); Group III (metastatic RCC)

Laboratory Biomarker Analysis OTHER

Correlative studies

Group I (no cancer or hematuria); Group II (localized RCC); Group III (metastatic RCC)

Magnetic Resonance Imaging PROCEDURE

Correlative studies

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Group II (localized RCC); Group III (metastatic RCC)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with renal cell carcinoma and their accompanying partners who are seen at the Urologic Oncology and Medical Oncology Clinics of the Keck Medical Center of University Southern California (USC), Norris Cancer Center, and USC-Los Angeles County Hospital will be recruited for this trial.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jacek Pinski, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 27, 2016
• Study Start: September 8, 2015
• Primary Completion: April 13, 2022
• Study Completion (Estimated): October 29, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)