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

NCT ID: NCT03291028

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients treated with immune check point blocker

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

Immune checkpoint inhibitor targeting PD1

Intervention Type: BIOLOGICAL

RCC and UC patients treated with immune checkpoint blockade

Patients treated with targeted/ observational therapy

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

No interventions assigned to this group

Interventions

Immune checkpoint inhibitor targeting PD1

RCC and UC patients treated with immune checkpoint blockade

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Zibelman, MD

Role: CONTACT

matthew.zibelman@fccc.edu

215 214 1515

Facility Contacts

Elizabeth Plimack, MD

Role: primary

Elizabeth.Plimack@fccc.edu

215-728-4790

Other Identifiers

GU-118

Identifier Type: -

Identifier Source: org_study_id