Actively Recruiting

All Genders
ID03291028

Genomic and Histologic Study of Primary and Metastatic Tumors in Renal Cell Carcinoma and Urothelial Carcinoma Patients Treated With Immune Checkpoint Blockade

Led by Fox Chase Cancer Center · Updated on 2025-01-10

16

Participants Needed

1

Research Sites

418 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying patients with renal cell carcinoma (RCC) and urothelial carcinoma (UC) who have undergone surgical removal of tumors followed by treatment with immune checkpoint blockade (ICB) targeting PD1. The study compares tumor samples taken before treatment and from metastatic sites after new lesions developed, to understand changes linked to metastasis and possible resistance. Additionally, metastatic samples from patients not treated with ICB will be compared to those treated with ICB to explore differences related to treatment resistance. The study involves collecting and analyzing tumor tissue samples from patients who had surgery to remove primary and metastatic lesions. Samples come from patients treated with ICB and those who were not, serving as a comparison group. The primary interventions being evaluated are the effects of the immune checkpoint inhibitor targeting PD1 on tumor characteristics. There are no new treatments administered during the study, as it focuses on analysis of existing surgical specimens. Participants contribute by allowing their previously removed tumor samples to be analyzed for histological and genomic changes over an 18-month period. Researchers will characterize these samples to identify differences in tumor biology between treated and untreated groups. The main outcomes measured are histopathological and genomic features of the tumors. This study does not involve additional treatments or long-term follow-up beyond the analysis of collected tissue samples.

CONDITIONS

Official Title

Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with renal cell carcinoma or urothelial carcinoma who received immune checkpoint blockade and had clinical benefit but later developed a single new or progressing lesion that was surgically removed
  • Patients with renal cell carcinoma who had a metastasectomy but did not receive immune checkpoint blockade treatment (to serve as a comparison group)
  • Patients with other tumor types meeting criteria may be included later
Not Eligible

You will not qualify if you...

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States, 19111-2497

Actively Recruiting

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Research Team

M

Matthew Zibelman, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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