Clinical trial · Observational
Gag-layer in the Urothelium of the Human Upper Urinary Tract
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chondroitin Sulfate Staining | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Renal Cell Carcinoma
- description
- patients undergoing radical nephrectomy because of renal clear cell carcinoma, tissue will be collected after the organ is removed.
- interventionNames
- Diagnostic Test: Chondroitin Sulfate Staining
- label
- Muscle Invasive Bladder Cancer
- description
- patients underoing radical cystectomi because of muscle-invasive bladder cancer, tissue will be collected after the organ is removed.
- interventionNames
- Diagnostic Test: Chondroitin Sulfate Staining
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available