Clinical trial NCT03291028: Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Cell Carcinoma
Urothelial Carcinoma
Bladder Cancer
Ureter Cancer
Urethral Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RCC and UC patients who were treated with ICB but developed metastatis post-treatment that was resected

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.


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:

-

Primary outcomes:
measure: Histopathological characterization of samples from ICB treated patients
timeFrame: 18 months
measure: Genomic characterization of samples from ICB treated patients
timeFrame: 18 months
Secondary outcomes:
measure: Histopathological characterization of samples from patients treated with targeted or observational therapy
timeFrame: 18 months
measure: Comparison of Histopathological characteristics of metastatic samples from ICB naive and treated patients
timeFrame: 18 months
measure: Genomic characterization of samples from patients treated with targeted or observational therapy
timeFrame: 18 months
measure: Comparison of genomic characteristics of metastatic samples from ICB naive and treated patients
timeFrame: 18 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
References: