Clinical trial · Observational
Longitudinal Bladder Cancer Study for Tumour Recurrence
An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.
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 |
|---|---|---|---|
| Urothelial Bladder Cancer | Urothelial Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CxBladder Monitor/Monitor+ | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single arm - Patients undergoing surveillance for UC recurrence
- description
- Subjects previously diagnosed with UC and are undergoing a schedule of surveillance cystoscopies and treatment for the possible recurrence of UC will be recruited. Low-, intermediate-, and high-risk groups, according to AUA /SUO risk categorisation for non-muscle invasive UC, will be eligible for this study. All subjects will undergo CxBladder urine diagnostic testing.
- interventionNames
- Diagnostic Test: CxBladder Monitor/Monitor+
Primary outcomes (1)
- measure
- To clinically validate the performance characteristics of CxBladder Monitor/Monitor+
- timeFrame
- 12 Months
- description
- To clinically validate the performance characteristics - sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and test-negative rate of Monitor and Monitor+ for the detection of recurrent UC in subjects with a recent history of urinary tract UC who are being treated according to standard of care and are concurrently undergoing routine investigative cystoscopy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years. 2. Subjects must agree to 4 successive study visits, including urine sample collection at each visit. 3. Physically able to provide a voided urine sample (a sample from catheterization is not eligible). 4. Able to give written informed consent 5. Able and willing to comply with study requirements 6. Aged 18 years or older Exclusion Criteria: 1. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits 2. Previous muscle invasive bladder tumour (pT2 or greater) 3. Known pregnancy Deferral Criteria 1. Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed. 2. Active urinary tract infection (UTI) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until the treatment is complete and the UTI is resolved. 3. If a subject has had intravesical immunotherapy or chemotherapy within the previous 6 weeks, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred. Study enrollment must be at least 28 calendar days post-last treatment.
References
Publications (0)
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