ACTIVE_NOT_RECRUITING

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

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Conditions

Carcinoma, Renal CellCarcinoma, Urothelial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2017-03-07
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02978118

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
  3. 3. Planned initiation of treatment with any of the following:
  4. * Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)
  5. * Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.
  6. 4. Age \> 18 years.
  7. 5. Ability to understand and the willingness to sign a written informed consent document.
  8. 1. Histologically confirmed diagnosis of urothelial carcinoma. Non-transitional cell carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed.
  9. 2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
  10. 3. Planned initiation of treatment with any of the following:
  11. * Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)
  12. * Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.
  13. 4. Age \> 18 years.
  14. 5. Ability to understand and the willingness to sign a written informed consent document.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Daniel George, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Duke University

  • Daniel George, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-03-07
Study Completion Date2028-10

Study Record Updates

Study Start Date2017-03-07
Study Completion Date2028-10

Terms related to this study

Additional Relevant MeSH Terms

  • Carcinoma, Renal Cell
  • Carcinoma, Urothelial