An observational study in Carcinoma, Renal Cell and Carcinoma, Urothelial, sponsored by Duke University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Duke University · Observational
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.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 67 is below the median of 146 across 360 observational studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Duke Cancer Institute Patients
Group A Renal Cell Carcinoma:
Patients will be eligible for inclusion in this study if ALL of the following criteria apply:
Planned initiation of treatment with any of the following:
Group B Urothelial Carcinoma:
Patients will be eligible for inclusion in this study if ALL of the following criteria apply:
Planned initiation of treatment with any of the following:
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
1. History of intercurrent or past condition that would make participation in this protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
Subjects in Group A (patients with locally advanced, high grade or metastatic renal cell carcinoma starting immunotherapy) will have blood collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression on treatment for analysis of peripheral blood mononuclear cells (PBMCs), circulating tumor cells (CTCs), metabolites, cytokines and angiokines. Urinary and fecal specimens will be collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression. Tissue will be collected at the time of a standard of care cytoreductive surgery (if applicable).
Device: Immune cell and CTC detection procedures
Subjects in Group B (patients with locally advanced, high grade or metastatic urothelial carcinoma starting immunotherapy) will have blood collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression on treatment for analysis of peripheral blood mononuclear cells (PBMCs), circulating tumor cells (CTCs), metabolites, cytokines and angiokines. Urinary and fecal specimens will be collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression. Tissue will be collected at the time of a standard of care cytoreductive surgery (if applicable).
Device: Immune cell and CTC detection procedures
Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)
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
Time frame: Baseline, Week 12, Progression (up to two years)
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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