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

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Renal Cancer Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chondroitin Sulfate Staining

Diagnostic Test

Staining of histopathological slides

Primary outcomes

Identification of a GAG layer in the upper urinary tract

Time frame: 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 outcomes

Thickness of the potential GAG layer in the upper urinary tract

Time frame: 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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

Ferring Ventures

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 1, 2022
Registry last updated: Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed