Clinical trial · Observational
Bladder EpiCheck European Haematuria Study
Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
NCT06818136CI-TRIAL-00101436recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed. Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cystoscopy | — | UNRESOLVED | — |
| Hematuria | — | UNRESOLVED | — |
| Urothelial Carcinoma Bladder | — | UNRESOLVED | — |
| Urothelial Carcinoma of the Renal Pelvis and Ureter | Renal Pelvis and Ureter Urothelial Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma of the Urinary Bladder | Bladder Urothelial Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bladder EpiCheck | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- aged ≥ 45 years with haematuria scheduled for cystoscopy, for suspicion of urothelial carcinoma
- description
- Adult participants aged ≥ 45 years presenting with haematuria in the past 6 months, scheduled to undergo haematuria workup, including cystoscopy, for suspicion of urothelial carcinoma.
- interventionNames
- Diagnostic Test: Bladder EpiCheck
Primary outcomes (1)
- measure
- The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma
- timeFrame
- urothelial carcinoma detected within 6 months of enrolment, by the standard of care haematuria work-up
- description
- The sensitivity and specificity of Bladder EpiCheck to detect primary urothelial carcinoma, calculated versus the Reference Standard defined by cystoscopy, imaging, and, if indicated, pathological confirmation) in participants presenting with haematuria (visible and/or non-visible).
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants aged 45 years or older 2. Participants who are willing and able to provide written informed consent and adhere to study procedures 3. Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment 4. Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment 5. Participants who are able to produce at least 10 ml of voided urine Exclusion Criteria: 1. Participants with history of urothelial cancer in the bladder and/or upper urinary tract 2. Participants who had prior cystoscopy for haematuria within the past 2 years 3. Participants previously enrolled in this study 4. Participants treated for prostate cancer within the last 12 months 5. Participants treated for kidney cancer within the last 12 months 6. Participants with untreated urinary tract infection 7. Participants with symptomatic urinary tract stones (e.g. flank pain) 8. Participants on dialysis for end stage renal failure 9. Participants with a long term urinary catheter 10. Pregnancy (self-reported) 11. Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway
References
Publications (1)
- RESULTWitjes JA, Morote J, Cornel EB, Gakis G, van Valenberg FJP, Lozano F, Sternberg IA, Willemsen E, Hegemann ML, Paitan Y, Leibovitch I. Performance of the Bladder EpiCheck Methylation Test for Patients Under Surveillance for Non-muscle-invasive Bladder Cancer: Results of a Multicenter, Prospective, Blinded Clinical Trial. Eur Urol Oncol. 2018 Sep;1(4):307-313. doi: 10.1016/j.euo.2018.06.011. Epub 2018 Jul 17. PMID 31100252