Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with immune check point blocker | Patients who were treated with immune checkpoint inhibitor targeting PD1 and developed metastatic lesion later |
| |
| Patients treated with targeted/ observational therapy | Patients who were not treated with immune checkpoint inhihibitor and developed metastatic lesion following other targeted therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune checkpoint inhibitor targeting PD1 | Biological | RCC and UC patients treated with immune checkpoint blockade |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histopathological characterization of samples from ICB treated patients | 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) | 18 months |
| Genomic characterization of samples from ICB treated patients | 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) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathological characterization of samples from patients treated with targeted or observational therapy | To characterize differences in histopathology between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy. | 18 months |
| Comparison of Histopathological characteristics of metastatic samples from ICB naive and treated patients |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
RCC and UC patients who were treated with ICB but developed metastatis post-treatment that was resected
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
Not provided
Not provided
Not provided
Not provided
Biopsied/ resected tumor samples that have been stored in the biosample repository would be used for the study
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. |
| 18 months |
| Genomic characterization of samples from patients treated with targeted or observational therapy | To characterize differences in patterns of genomic expression between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy | 18 months |
| Comparison of genomic characteristics of metastatic samples from ICB naive and treated patients | To characterize differences in patterns of genomic expression between "escape" metastases in patients treated with ICB from patients treated with targeted therapy or observation. | 18 months |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D002295 | Carcinoma, Transitional Cell |
| D001749 | Urinary Bladder Neoplasms |
| D014516 | Ureteral Neoplasms |
| D014523 | Urethral Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014515 | Ureteral Diseases |
| D014522 | Urethral Diseases |
Not provided
Not provided