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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Carcinoma, Renal Cell
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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.
  • 2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
  • 3. 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.
  • 4. Age \> 18 years.
  • 5. Ability to understand and the willingness to sign a written informed consent document.
  • 1. Histologically confirmed diagnosis of urothelial carcinoma. Non-transitional cell carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed.
  • 2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
  • 3. 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.
  • 4. Age \> 18 years.
  • 5. Ability to understand and the willingness to sign a written informed consent document.
  • 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Tian Zhang, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2028-10