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
| Name | Class |
|---|---|
| Ferring Ventures | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Urothelial carcinomas of the lower and upper urinary tract can be considered "twin diseases". Much of the current clinical decision-making surrounding Upper Tract Urothelial Carcinoma (UTUC) is extrapolated from evidence that is based on urothelial carcinoma of bladder patients.
The inner wall of the bladder is coated with a substance called glycosaminoglycan (GAG). GAG is known to form a gel-like layer on the apical cell membrane and act as a barrier against urine and pathogens in the lower urinary tract.
Currently no published research on the presence of a GAG layer in the upper urinary tract exists. However, literature suggests that the ureteral utothelium can be transduced without enhancers, and the ureteral urothelium may be intrinsically different from bladder, both by the presence or absence of a GAG-layer, by different composition/thickness of the GAG-layer.
Any functional differences between the urothelial layers in the bladder and in the upper urinary tract may affect the adeno-virus transduction, which again will have potential impact on future treatment of UTUC patients with a current unmet medical need.
This study will include patients either undergoing radical nephrectomy or radical cystectomy. After organ removal during surgery a biopsi (1x1 cm) will be collected from the ureter and the renal pelvis or from the ureter and the bladder (depending on type of surgery).
These biopsies will be examined and compared, using molecular biotechniques, for the presence of glykosamino glykan (GAG) layer.
There is no project related follow up for patients included, other than what is standard post-operative regime in the department.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Cell Carcinoma | patients undergoing radical nephrectomy because of renal clear cell carcinoma, tissue will be collected after the organ is removed. |
| |
| Muscle Invasive Bladder Cancer | patients underoing radical cystectomi because of muscle-invasive bladder cancer, tissue will be collected after the organ is removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chondroitin Sulfate Staining | Diagnostic Test | Staining of histopathological slides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of a GAG layer in the upper urinary tract | Number of specimens with presence of GAG layer by histopatological staining | samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected |
| Measure | Description | Time Frame |
|---|---|---|
| Thickness of the potential GAG layer in the upper urinary tract | Compare the morphological and histological features of a GAG layer in the upper urinary tract to that of the bladder | samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients undergoing cystectomy or nephrectomy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jørgen B Jensen, Dr. Med. | AUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
a 1x1cm biopsi from the bladder or the renal pelvis along with a 1x1cm biopsi from the urether.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007674 | Kidney Diseases |