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

NCT02978118 | Active Not Recruiting

• 1 other identifier: Pro00076768
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Renal Cell; Carcinoma, Urothelial

Outcome Measures

Primary Outcomes (5)

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

  Baseline and Disease progression (up to two years)

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

  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

  Baseline and Disease progression (up to two years)

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

  Baseline and Disease progression (up to two years)

• Number of patients with detectable circulating tumor cells (CTCs)

  Disease progression (up to two years)

Secondary Outcomes (5)

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

  Baseline

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

  Baseline

• The change in CTCs over time

  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

  Disease progression (up to two years)

• The change in tumor burden over time measured by RECIST

  Baseline, Week 12, Progression (up to two years)

Study Arms (2)

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).

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).

Device: Immune cell and CTC detection procedures

Interventions

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)

Group A: Renal Cell Carcinoma; Group B: Urothelial Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Duke Cancer Institute Patients

You may qualify if:

• Group A Renal Cell Carcinoma:
• 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:
• 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• Duke University: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Daniel George, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: November 30, 2016
• Study Start: March 7, 2017
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)