This pilot study purpose of this study is to describe peripheral circulating immune cell profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell carcinoma and urothelial carcinoma.
Study Type
OBSERVATIONAL
Enrollment
67
Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)
Duke University Medical Center
Durham, North Carolina, United States
Change in the number of T-cells before and after treatment with immune therapies
Time frame: Baseline and Disease progression (up to two years)
Change in the number of B-cells before and after treatment with immune therapies
Time frame: Baseline and Disease progression (up to two years)
Change in the number of myeloid-derived suppressor cells (MDSCs) before and after treatment with immune therapies
Time frame: Baseline and Disease progression (up to two years)
Change in the number of neutrophil cells before and after treatment with immune therapies
Time frame: Baseline and Disease progression (up to two years)
Number of patients with detectable circulating tumor cells (CTCs)
Time frame: Disease progression (up to two years)
The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline
Time frame: Baseline
The prevalence of tumor-associated macrophages for all subjects at baseline
Time frame: Baseline
The change in CTCs over time
Time frame: Baseline, week 4, week 8, week 12 and progression (up to two years)
The distribution of CTCs difference scores across the ordered tumor response categories of CR, PR, SD, and PD
Time frame: Disease progression (up to two years)
The change in tumor burden over time measured by RECIST
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, Week 12, Progression (up to two years)