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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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,142 studies in Carcinoma, Renal Cell with a site in United States — 157 open to participants now, 280 under way, 26 of them phase 3. Carcinoma, Renal Cell · United States.

Enrollment
73rd of 87
15 · median 100
Started
2017
with 55 others
Observational
87 of 1,142
17 open now
Primary completion
2026-12
later than 72 of 278 live
Registered
702nd of 1,142
by date

Among the 1,142 studies in Carcinoma, Renal Cell with a site in United States, this one is the 73rd largest by enrollment of the 87 observational ones that give a count, is one of 56 that started in 2017, is one of 87 observational ones, reaches primary completion later than 72 of the 278 other live ones, and was the 702nd registered.

Carcinoma, Renal Cell

2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.

Browse Carcinoma, Renal Cell studies →

Open to participants now

157 of the 1,142 studies in Carcinoma, Renal Cell with a site in United States are open now. Recruiting first, the newest first:

152 more — sign in →

All 157 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 308 Carcinoma, Renal Cell studies recruiting now, 255 (83%) set no upper age limit and 18 (6%) stop at 75 or younger; 20 take children under 18; 19 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Renal Cell Carcinoma
  • Urothelial Carcinoma
  • Bladder Cancer
  • Ureter Cancer
  • Urethral Cancer
04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

-

05

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

06

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

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2017 (actual). Primary completion is estimated for Dec 2026, 109 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2017
First posted
Sep 25, 2017
StartActual
Nov 27, 2017
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03291028
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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Discussion

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