RecruitingNCT03291028

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

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)


Sponsor

Fox Chase Cancer Center

Enrollment

16 participants

Start Date

Nov 27, 2017

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria2

  • 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 Criteria1

  • \-

Interventions

BIOLOGICALImmune checkpoint inhibitor targeting PD1

RCC and UC patients treated with immune checkpoint blockade


Locations(1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

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NCT03291028


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