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

Bladder Cancer Clinical Trial

Official title:

Defining the Genomic and Histologic Landscape of Primary and Metastatic Tumors With Divergent Kinetics in Patients With Renal Cell Carcinoma (RCC) and Urothelial Carcinoma (UC) Treated With Immune Checkpoint Blockade (ICB)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03291028
• Other study ID #: GU-118
• Status: Recruiting
• Start date: November 27, 2017
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Fox Chase Cancer Center
• Contact: Matthew Zibelman, MD
• Phone: 215 214 1515
• Email: matthew.zibelman[@]fccc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma, Renal Cell
• Carcinoma, Transitional Cell
• Neoplasm Metastasis
• Renal Cell Carcinoma
• Ureter Cancer
• Ureteral Neoplasms
• Urethral Cancer
• Urethral Neoplasms
• Urothelial Carcinoma

Intervention

Biological:
• Immune checkpoint inhibitor targeting PD1
RCC and UC patients treated with immune checkpoint blockade

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	18 months
Primary	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)	18 months
Secondary	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.	18 months
Secondary	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.	18 months
Secondary	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	18 months
Secondary	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.	18 months