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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05400291
• Other study ID #: GAG
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Kidney Neoplasms
• Renal Cancer

Intervention

Diagnostic Test:
• Chondroitin Sulfate Staining
Staining of histopathological slides

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Ferring Ventures

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of a GAG layer in the upper urinary tract	Number of specimens with presence of GAG layer by histopatological staining	samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected
Secondary	Thickness of the potential GAG layer in the upper urinary tract	Compare the morphological and histological features of a GAG layer in the upper urinary tract to that of the bladder	samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected