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Brief 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)

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)

INTRODUCTION

  • Org Study ID: GU-118
  • Secondary ID: N/A
  • NTC ID: NCT03291028
  • Sponsor: Fox Chase Cancer Center

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.


  • Overall Status
    Recruiting
  • Start Date
    November 27, 2017
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Histopathological characterization of samples from ICB treated patients

Primary Outcome 1 - Timeframe: 18 months

Primary Outcome 2 - Measure: Genomic characterization of samples from ICB treated patients

Primary Outcome 2 - Timeframe: 18 months

CONDITION

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

ELIGIBILITY


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

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 215 214 1515

Email: matthew.zibelman@fccc.edu

LOCATION

Facility Status Contact
Facility: Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania 19111-2497
United States
Status: Recruiting Contact:
Elizabeth Plimack, MD
215-728-4790
Elizabeth.Plimack@fccc.edu