Clinical trial NCT05400291: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Renal Cancer
Keywords: glykosaminoglycan layer
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Ferring Ventures
First posted: 2022-06-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cystectomy or nephrectomy

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 criteria: Inclusion Criteria:

* Bladder cancer or renal cell carcinoma
* Ability to understand and sign informed consent form

Exclusion Criteria:

* Previous history of cancer
* Immune suppressing medication
* Treatment with local or systemic steroids (\< 3 months prior to enrollment)
* Treatment with antibiotics due to urinary tract infection or pyelonephritis (\< 3 months prior to enrollment)
* Previous radiation therapy of the pelvic floor
* Ureteric stent
* Dilatation of the upper urinary tract detected on imaging
* Dilatation of the upper urinary tract detected on imaging

Primary outcomes:
measure: Identification of a GAG layer in the upper urinary tract
timeFrame: samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected
Secondary outcomes:
measure: Thickness of the potential GAG layer in the upper urinary tract
timeFrame: samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: AUH
name: Jørgen B Jensen, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References: