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Active, Not Recruiting

NCT Number: NCT02978118

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Carcinoma, Urothelial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

  • 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).

Treatment and study plan

Immune cell and CTC detection procedures

Device

Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)

Primary outcomes

  1. Change in the number of T-cells before and after treatment with immune therapies

    Time frame: Baseline and Disease progression (up to two years)

  2. Change in the number of B-cells before and after treatment with immune therapies

    Time frame: Baseline and Disease progression (up to two years)

  3. 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)

  4. Change in the number of neutrophil cells before and after treatment with immune therapies

    Time frame: Baseline and Disease progression (up to two years)

  5. Number of patients with detectable circulating tumor cells (CTCs)

    Time frame: Disease progression (up to two years)

Secondary outcomes

  1. The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline

    Time frame: Baseline

  2. The prevalence of tumor-associated macrophages for all subjects at baseline

    Time frame: Baseline

  3. The change in CTCs over time

    Time frame: Baseline, week 4, week 8, week 12 and progression (up to two years)

  4. 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)

  5. The change in tumor burden over time measured by RECIST

    Time frame: Baseline, Week 12, Progression (up to two years)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of Wisconsin, Madison

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Nov 30, 2016
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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