Brief Title
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)
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.
Study Type
Observational
Primary Outcome
Histopathological characterization of samples from ICB treated patients
Secondary Outcome
Histopathological characterization of samples from patients treated with targeted or observational therapy
Condition
Renal Cell Carcinoma
Intervention
Immune checkpoint inhibitor targeting PD1
Study Arms / Comparison Groups
Patients treated with immune check point blocker
Description: Patients who were treated with immune checkpoint inhibitor targeting PD1 and developed metastatic lesion later
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
16
Start Date
November 27, 2017
Completion Date
December 2021
Primary Completion Date
December 2021
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:
-
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, 215 214 1515, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03291028
Organization ID
GU-118
Responsible Party
Sponsor
Study Sponsor
Fox Chase Cancer Center
Study Sponsor
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Verification Date
October 2021