Carcinoma, Renal CellNCT02978118
Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies (CTC Immune Based Biomarkers)
An observational study of Carcinoma, Renal Cell and Carcinoma, Urothelial, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Carcinoma, Urothelial
- What is being tested?
- Immune cell and CTC detection procedures
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2017to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Duke Cancer Institute Patients
Who may be able to join
- Group A Renal Cell Carcinoma:
- Patients will be eligible for inclusion in this study if ALL of the following criteria apply:
- Histologically confirmed or radiological diagnosis of renal cell carcinoma. Clear cell and non-clear cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary) allowed.
- Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
- Planned initiation of treatment with any of the following:
- Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)
Show all 18Show fewer
- Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.
- Age > 18 years.
- Ability to understand and the willingness to sign a written informed consent document.
- Group B Urothelial Carcinoma:
- Patients will be eligible for inclusion in this study if ALL of the following criteria apply:
- Histologically confirmed diagnosis of urothelial carcinoma. Non-transitional cell carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed.
- Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
- Planned initiation of treatment with any of the following:
- Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)
- Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.
- Age > 18 years.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies
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.
- Conditions
- Carcinoma, Renal Cell, Carcinoma, Urothelial
- Being tested
- Immune cell and CTC detection procedures
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune cell and CTC detection proceduresDevice
Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)
| Study group | Role | What they receive |
|---|---|---|
| Group A: Renal Cell Carcinoma | 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). Receives: Device: Immune cell and CTC detection procedures | |
| Group B: Urothelial Carcinoma | 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). Receives: Device: Immune cell and CTC detection procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of T-cells before and after treatment with immune therapies
Measured: Baseline and Disease progression (up to two years)
Change in the number of B-cells before and after treatment with immune therapies
Measured: 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
Measured: Baseline and Disease progression (up to two years)
Change in the number of neutrophil cells before and after treatment with immune therapies
Measured: Baseline and Disease progression (up to two years)
Number of patients with detectable circulating tumor cells (CTCs)
Measured: Disease progression (up to two years)
Secondary outcomes (5)
The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline
Measured: Baseline
The prevalence of tumor-associated macrophages for all subjects at baseline
Measured: Baseline
The change in CTCs over time
Measured: 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
Measured: Disease progression (up to two years)
The change in tumor burden over time measured by RECIST
Measured: Baseline, Week 12, Progression (up to two years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start7 Mar 2017
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Daniel George, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978118
- Sponsor's protocol ID
- Pro00076768
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2016
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies
- ClinicalTrials.gov ID
- NCT02978118
- Acronym / sponsor ID
- Pro00076768
- Conditions
- Carcinoma, Renal Cell, Carcinoma, Urothelial
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Renal Cell Carcinoma | – | Device: Immune cell and CTC detection proceduresSubjects 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). |
| Group B: Urothelial Carcinoma | – | Device: Immune cell and CTC detection proceduresSubjects 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Duke Cancer Institute Patients
Key inclusion criteria (18 listed)
- Patients will be eligible for inclusion in this study if ALL of the following criteria apply:
- Histologically confirmed or radiological diagnosis of renal cell carcinoma. Clear cell and non-clear cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary) allowed.
- Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
- Planned initiation of treatment with any of the following:
- Age > 18 years.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune cell and CTC detection proceduresImmune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples) | Device | Group A: Renal Cell Carcinoma, Group B: Urothelial Carcinoma |
Primary outcome
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)
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel George, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Renal Cell and Carcinoma, Urothelial, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of T-cells before and after treatment with immune therapies (time frame: Baseline and Disease progression (up to two years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.