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NCT02978118Active, not recruiting

Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies (CTC Immune Based Biomarkers)

Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
67 (actual)
First submitted
21 Oct 2016
Start date
7 Mar 2017
Primary completion date
Oct 2028
Lead sponsor
Duke University
NCT number
NCT02978118

What you commit to

  • Study type: Observational
  • Participants enrolled: 67
  • From 7 Mar 2017 to the primary completion date, Oct 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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).

Other

  • A patient will not be eligible for inclusion in this study if any of the following criteria apply:

Who the study is looking for

  • 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)
    • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke University Medical Center
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.