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Spots Global Cancer Trial Database for Gag-layer in the Urothelium of the Human Upper Urinary Tract

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Trial Identification

Brief Title: Gag-layer in the Urothelium of the Human Upper Urinary Tract

Official Title: Gag-layer in the Urothelium of the Human Upper Urinary Tract

Study ID: NCT05400291

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Aarhus University Hospital, Aarhus, , Denmark

Contact Details

Name: Jørgen B Jensen, Dr. Med.

Affiliation: AUH

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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