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

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ClinicalTrials.gov Identifier: NCT03291028
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Renal Cell Carcinoma Urothelial Carcinoma Bladder Cancer Ureter Cancer Urethral Cancer Biological: Immune checkpoint inhibitor targeting PD1

Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Group/Cohort Intervention/treatment
Patients treated with immune check point blocker
Patients who were treated with immune checkpoint inhibitor targeting PD1 and developed metastatic lesion later
Biological: Immune checkpoint inhibitor targeting PD1
RCC and UC patients treated with immune checkpoint blockade

Patients treated with targeted/ observational therapy
Patients who were not treated with immune checkpoint inhihibitor and developed metastatic lesion following other targeted therapy



Primary Outcome Measures :
  1. Histopathological characterization of samples from ICB treated patients [ Time Frame: 18 months ]
    To characterize differences in histopathology and patterns of genomic expression between baseline tumors and metastases exhibiting divergent growth kinetics ("escape" metastases) in patients treated with immune checkpoint blockade (ICB)

  2. Genomic characterization of samples from ICB treated patients [ Time Frame: 18 months ]
    To characterize expression of different genes between baseline tumors and metastases exhibiting divergent growth kinetics ("escape" metastases) in patients treated with immune checkpoint blockade (ICB)


Secondary Outcome Measures :
  1. Histopathological characterization of samples from patients treated with targeted or observational therapy [ Time Frame: 18 months ]
    To characterize differences in histopathology between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy.

  2. Comparison of Histopathological characteristics of metastatic samples from ICB naive and treated patients [ Time Frame: 18 months ]
    To characterize differences in histopathology and patterns of genomic expression between "escape" metastases in patients treated with ICB from patients treated with targeted therapy or observation.

  3. Genomic characterization of samples from patients treated with targeted or observational therapy [ Time Frame: 18 months ]
    To characterize differences in patterns of genomic expression between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy

  4. Comparison of genomic characteristics of metastatic samples from ICB naive and treated patients [ Time Frame: 18 months ]
    To characterize differences in patterns of genomic expression between "escape" metastases in patients treated with ICB from patients treated with targeted therapy or observation.


Biospecimen Retention:   Samples With DNA
Biopsied/ resected tumor samples that have been stored in the biosample repository would be used for the study


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RCC and UC patients who were treated with ICB but developed metastatis post-treatment that was resected
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291028


Contacts
Contact: Matthew Zibelman, MD 215 214 1515 matthew.zibelman@fccc.edu

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

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT03291028     History of Changes
Other Study ID Numbers: GU-118
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urethral Neoplasms
Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Renal Cell
Carcinoma, Transitional Cell
Neoplasm Metastasis
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Kidney Neoplasms
Kidney Diseases
Urethral Diseases
Neoplastic Processes
Pathologic Processes
Ureteral Diseases