NCT05400291

Gag-layer in the Urothelium of the Human Upper Urinary Tract

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bladder Cancer
• Renal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Chondroitin Sulfate Staining	Staining of histopathological slides

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-06-01
• Last updated: 2023-06-01

Locations

1 site across 1 country: Denmark