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

Temple University Health System (TUHS)

Status: Enrolling

Conditions: Bladder Cancer; Ureter Cancer; Urothelial Carcinoma; Renal Cell Carcinoma; Urethral Cancer

Treatments: Biological: Immune checkpoint inhibitor targeting PD1

Study type: Observational

Funder types: Other

Identifiers

NCT03291028

GU-118

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

16 participants in 2 patient groups

Patients treated with immune check point blocker

Description:

Patients who were treated with immune checkpoint inhibitor targeting PD1 and developed metastatic lesion later

Treatment:

Biological: Immune checkpoint inhibitor targeting PD1

Patients treated with targeted/ observational therapy

Description:

Patients who were not treated with immune checkpoint inhihibitor and developed metastatic lesion following other targeted therapy