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Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer

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ClinicalTrials.gov Identifier: NCT02664883
Recruitment Status : Recruiting
First Posted : January 27, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment
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 Procedure: Computed Tomography Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis Procedure: Magnetic Resonance Imaging

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.


Study Type : Observational
Estimated Enrollment : 63 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: MDSC Clinical Assay for Cancer Detection and Monitoring in Renal Cell Carcinoma
Actual Study Start Date : September 8, 2015
Estimated Primary Completion Date : September 8, 2019
Estimated Study Completion Date : September 8, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Undergo collection of blood and urine samples
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Correlative studies

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
Correlative studies
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Other: Cytology Specimen Collection Procedure
Undergo collection of blood and urine samples
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Magnetic Resonance Imaging
Correlative studies
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear 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
Correlative studies
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Other: Cytology Specimen Collection Procedure
Undergo collection of blood and urine samples
Other Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Magnetic Resonance Imaging
Correlative studies
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging




Primary Outcome Measures :
  1. 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 ]
    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.

  2. Change in MDSC level in patients with localized renal cell carcinoma who undergo nephrectomy [ Time Frame: Baseline to 30 days after nephrectomy ]
  3. Mean MDSC level [ Time Frame: Baseline ]
    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.


Biospecimen Retention:   Samples With DNA
Blood and urine samples


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664883


Contacts
Contact: Elysse Ballon 323-865-0464 elyssefaye.ballon@med.usc.edu

Locations
United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Jacek Pinski    323-865-3929    pinski@med.usc.edu   
Principal Investigator: Jacek Pinski         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jacek Pinski University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02664883     History of Changes
Other Study ID Numbers: 4K-14-4
NCI-2015-01559 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HS-15-00309
4K-14-4 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases