Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer

Healthy Subject Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02664883
• Other study ID #: 4K-14-4
• Secondary ID: NCI-2015-01559HS
• Status: Active, not recruiting
• Start date: September 8, 2015
• Est. completion date: September 8, 2024

Study information

• Verified date: April 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: September 8, 2024
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• 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
Correlative studies

Other:
• Cytology Specimen Collection Procedure
Undergo collection of blood and urine samples
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Magnetic Resonance Imaging
Correlative studies

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in MDSC level in patients with localized renal cell carcinoma who undergo nephrectomy		Baseline to 30 days after nephrectomy
Primary	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