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

Fox Chase Cancer Center16 enrolled

Overview

This is a comparative study using resected/ biopsied tumors samples collected from renal cell carcinoma and urothelial carcinoma patients who underwent surgical removal of lesions, followed by immune checkpoint blockade (ICB) treatment targting programmed cell death 1 (PD1) but developed new lesions later were also removed and stored in the biosample repository (BSR). The histology and genomic analysis of the pre-treatment and metastatic samples from the same patient would be used to find out the changes that may have lead to metastasis. Also, metastatic samples from ICB naive patients would be collected and compared with those from ICB treated patients to find out if the metastasis in treated patients was due to development of reistance.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Renal Cell Carcinoma Urothelial Carcinoma Bladder Cancer Ureter Cancer Urethral Cancer

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Eligible patients will include retrospectively identified patients with RCC or UC who have received treatment with ICB and achieved clinical benefit but subsequently developed a solitary new/progressive lesion that was removed surgically. Patients with other tumor types who otherwise meet criteria may be included at a later time * Additionally, a group of patients with RCC who have undergone a metastasectomy but who did not receive treatment with ICB will be identified. These patients may be approached for study participation to serve as a comparator group Exclusion Criteria: \-

Outcomes

Primary Outcomes

Histopathological characterization of samples from ICB treated patients

To characterize differences in histopathology and patterns of genomic expression between baseline tumors and metastases exhibiting divergent growth kinetics ("escape" metastases) in patients treated with immune checkpoint blockade (ICB)

Time frame: 18 months

Genomic characterization of samples from ICB treated patients

To characterize expression of different genes between baseline tumors and metastases exhibiting divergent growth kinetics ("escape" metastases) in patients treated with immune checkpoint blockade (ICB)

Time frame: 18 months

Secondary Outcomes

Histopathological characterization of samples from patients treated with targeted or observational therapy

To characterize differences in histopathology between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy.

Time frame: 18 months

Comparison of Histopathological characteristics of metastatic samples from ICB naive and treated patients

To characterize differences in histopathology and patterns of genomic expression between "escape" metastases in patients treated with ICB from patients treated with targeted therapy or observation.

Time frame: 18 months

Genomic characterization of samples from patients treated with targeted or observational therapy

To characterize differences in patterns of genomic expression between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy

Time frame: 18 months

Comparison of genomic characteristics of metastatic samples from ICB naive and treated patients

To characterize differences in patterns of genomic expression between "escape" metastases in patients treated with ICB from patients treated with targeted therapy or observation.

Time frame: 18 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts