Bladder Cancer, Renal Cell Carcinoma, Ureter Cancer, Urethral Cancer, Urothelial Carcinoma
Conditions
Brief summary
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.
Interventions
BIOLOGICALImmune checkpoint inhibitor targeting PD1
RCC and UC patients treated with immune checkpoint blockade
Sponsors
Fox Chase Cancer Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histopathological characterization of samples from ICB treated patients | 18 months | 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) |
| Genomic characterization of samples from ICB treated patients | 18 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histopathological characterization of samples from patients treated with targeted or observational therapy | 18 months | To characterize differences in histopathology between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy. |
| Comparison of Histopathological characteristics of metastatic samples from ICB naive and treated patients | 18 months | 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. |
| Genomic characterization of samples from patients treated with targeted or observational therapy | 18 months | To characterize differences in patterns of genomic expression between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy |
| Comparison of genomic characteristics of metastatic samples from ICB naive and treated patients | 18 months | To characterize differences in patterns of genomic expression between "escape" metastases in patients treated with ICB from patients treated with targeted therapy or observation. |
Countries
United States
Outcome results
None listed