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.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | November 27, 2017 | Observational |
Primary Outcome 1 - Measure: Histopathological characterization of samples from ICB treated patients
Primary Outcome 1 - Time Frame: 18 months
Primary Outcome 2 - Measure: Genomic characterization of samples from ICB treated patients
Primary Outcome 2 - Time Frame: 18 months
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:
-
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Gender: All
Minimum Age: N/A
Maximum Age: N/A
Healthy Volunteers: No
Name: Matthew Zibelman, MD
Phone: 215 214 1515
Email: matthew.zibelman@fccc.edu
| Facility | Status | Contact |
|---|---|---|
| Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania 19111-2497 United States |
Recruiting |
Elizabeth Plimack, MD 215-728-4790 Elizabeth.Plimack@fccc.edu |
