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

NCT05400291 | Completed

• 1 other identifier: GAG
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Renal Cancer

Keywords

glykosaminoglycan layer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Renal Cell Carcinoma

patients undergoing radical nephrectomy because of renal clear cell carcinoma, tissue will be collected after the organ is removed.

Diagnostic Test: Chondroitin Sulfate Staining

Muscle Invasive Bladder Cancer

patients underoing radical cystectomi because of muscle-invasive bladder cancer, tissue will be collected after the organ is removed.

Diagnostic Test: Chondroitin Sulfate Staining

Interventions

Chondroitin Sulfate Staining DIAGNOSTIC_TEST

Staining of histopathological slides

Muscle Invasive Bladder Cancer; Renal Cell Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cystectomy or nephrectomy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Ferring Ventures: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

a 1x1cm biopsi from the bladder or the renal pelvis along with a 1x1cm biopsi from the urether.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Kidney Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jørgen B Jensen, Dr. Med.

  AUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor. MD

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: June 1, 2022
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

DK (1)