Clinical trial · Observational
Urinary Biomarkers in the Detection of Urothelial Carcinoma of the Bladder
- 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)
To assess the persistence of bladder cancer-specific biomarkers in urine collected pre-operatively, in resected cancer tissue, and in urine collected post-operatively. A panel of sensitive and specific bladder cancer biomarkers will be used to establish a signature of disease in pre-operative patients with a positive diagnosis for bladder cancer by current standard of care (e.g., in-office cystoscopy, OR cystoscopy). The specificity of these markers will be assessed, as well as the degree of non-specific signal attributable to other sources of biomolecules, by analyzing resected tumor tissue for the same biomarkers. Finally, post-operative urine will be assessed for the presence of these markers. To the extent this biomarker panel can be determined to be specific and sensitive, it may serve as an indicator of the degree to which the surgical intervention successfully eradicated the underlying disease. The investigators also aim to assess the stability of a biomarker signature in urine but evaluating several patient specimens over various time points throughout the day.
Conditions
Conditions (1)
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, Biomarkers | Malignant Bladder Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of urine and bladder tumor specimens | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in urinary biomarker value from baseline following removal of bladder tumor
- timeFrame
- An average of 1 month after surgery
- description
- Urinary biomarkers will be assessed pre-operatively from voided specimens. One month post-operatively, voided urine will again be assessed for changes in the level of urinary biomarker. DNA will be isolated from tissue or urine using commercially available validated kits. DNA will be quantified by standard procedures and analyzed for somatic mutation by targeted resequencing of selected regions of the genome. Specific gene targets include TP53, FGFR3, CDKN2A, TERT, and PIK3CA. Hypermethylation analysis will be conducted by bisulfite conversion of isolated DNA and sequencing to determine degree of methylation of specific CpG islands. CpG islands located in the promoter regions of OTX1, TWIST1 and ONECUT2 will be analyzed. Levels of Cystatin B will be assessed by quantitative immunoassay directly from urine.
Secondary outcomes (1)
- measure
- Change in urinary biomarker value throughout the day
- timeFrame
- One day
- description
- 5 patients will provide and additional 2 pre-operative urine specimens (for a total of 3 preoperative specimens) from a single day to assess for any potential time-dependent variation. Each specimen must be collected at least 4 hours apart. These 5 patients will be asked to collect a "morning", "midday" and "evening" urine specimen.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected or confirmed urothelial type bladder cancer * Scheduled for a transurethral resection of bladder tumor (TURBT) or cystectomy Exclusion Criteria: * Less than 18 years of age * Known concurrent upper urinary tract disease * History of bladder or prostate radiation * Patients who are unwilling or unable to give consent
References
Publications (3)
- BACKGROUNDSjodahl G, Lauss M, Lovgren K, Chebil G, Gudjonsson S, Veerla S, Patschan O, Aine M, Ferno M, Ringner M, Mansson W, Liedberg F, Lindgren D, Hoglund M. A molecular taxonomy for urothelial carcinoma. Clin Cancer Res. 2012 Jun 15;18(12):3377-86. doi: 10.1158/1078-0432.CCR-12-0077-T. Epub 2012 May 2. PMID 22553347
- BACKGROUNDSylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17. PMID 16442208
- BACKGROUNDCancer Genome Atlas Research Network. Comprehensive molecular characterization of urothelial bladder carcinoma. Nature. 2014 Mar 20;507(7492):315-22. doi: 10.1038/nature12965. Epub 2014 Jan 29. PMID 24476821