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

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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

, ,

Verification Date

October 2021