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

NCT03291028 | Recruiting

• 1 other identifier: GU-118
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

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

  18 months

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

  18 months

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

  18 months

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

  18 months

Study Arms (2)

Patients treated with immune check point blocker

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

Biological: Immune checkpoint inhibitor targeting PD1

Patients treated with targeted/ observational therapy

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

Interventions

Immune checkpoint inhibitor targeting PD1 BIOLOGICAL

RCC and UC patients treated with immune checkpoint blockade

Patients treated with immune check point blocker

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

RCC and UC patients who were treated with ICB but developed metastatis post-treatment that was resected

You may qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biopsied/ resected tumor samples that have been stored in the biosample repository would be used for the study

MeSH Terms

Conditions

Carcinoma, Renal Cell; Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Ureteral Neoplasms; Urethral Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Ureteral Diseases; Urethral Diseases

Central Study Contacts

Matthew Zibelman, MD

CONTACT

215 214 1515; matthew.zibelman@fccc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 25, 2017
• Study Start: November 27, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

US (1)