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Active, not recruitingNCT03291028Updated May 22, 2026

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

An observational study in Renal Cell Carcinoma, Urothelial Carcinoma and Bladder Cancer, sponsored by Fox Chase Cancer Center. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Fox Chase Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
15
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Cell Carcinoma
  • Urothelial Carcinoma
  • Bladder Cancer
  • Ureter Cancer
  • Urethral Cancer
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

-

04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
15 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • BiologicalImmune checkpoint inhibitor targeting PD1

    RCC and UC patients treated with immune checkpoint blockade

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 18 months

  2. 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)

    Time frame: 18 months

Secondary outcomes

  1. 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.

    Time frame: 18 months

  2. 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.

    Time frame: 18 months

  3. 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

    Time frame: 18 months

  4. 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.

    Time frame: 18 months

06

Study locations

1 site
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania 19111-2497, United States
07

Registry details

Key details

Study ID
NCT03291028
Lead sponsor
Fox Chase Cancer Center
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Nov 27, 2017
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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