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

Completed

• Conditions: Renal Cancer; Bladder Cancer
• Interventions: Diagnostic Test: Chondroitin Sulfate Staining

• Registration Number: NCT05400291
• Lead Sponsor: Aarhus University Hospital

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.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-05-30
• Study First Posted: 2022-06-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Muscle Invasive Bladder Cancer	Chondroitin Sulfate Staining	patients underoing radical cystectomi because of muscle-invasive bladder cancer, tissue will be collected after the organ is removed.
Renal Cell Carcinoma	Chondroitin Sulfate Staining	patients undergoing radical nephrectomy because of renal clear cell carcinoma, tissue will be collected after the organ is removed.

Primary Outcome Measures

Name	Time	Method
Identification of a GAG layer in the upper urinary tract	samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected	Number of specimens with presence of GAG layer by histopatological staining

Secondary Outcome Measures

Name	Time	Method
Thickness of the potential GAG layer in the upper urinary tract	samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected	Compare the morphological and histological features of a GAG layer in the upper urinary tract to that of the bladder

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark