Clinical trial · Observational
BladMetrix Urine Test for Monitoring Recurrence in Non-Muscle Invasive Bladder Cancer
National Multicenter Observational Study of Urine-Based BladMetrix Monitoring for Recurrence in Non-Muscle Invasive Bladder Cancer
- 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)
This observational study evaluates the urine test BladMetrix for monitoring bladder cancer recurrences in people with non muscle invasive bladder cancer (NMIBC) who are in follow-up after surgery. The main goal is to evaluate the potential clinical utility of the BladMetrix test by comparing its performance with current follow-up methods, cystoscopy (looking into the bladder with a camera) and urine cytology (examining cells in the urine), using confirmed pathological histology as the reference standard for recurrence (return of disease). Participants will be adults with NMIBC and a positive BladMetrix urine test at the time of their bladder tumor surgery (transurethral resection). After surgery, they will continue their usual follow-up at their local hospital according to national guidelines, including regular cystoscopies and urine cytology. At each planned follow-up visit over about 2 years, they will provide an extra urine sample for BladMetrix testing in addition to their routine examinations. By comparing BladMetrix results with cystoscopy, urine cytology, and histology from any biopsies or tissue from surgery, we will estimate diagnostic accuracy measures such as sensitivity, specificity, negative predictive value, and positive predictive value for detecting bladder cancer recurrence. The goal is to see whether the BladMetrix urine test could safely replace parts of the cystoscopies, help clarify uncertain cystoscopy findings, and support more individualized follow-up schedules for people living with NMIBC.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Transitional Cell, Bladder | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Non-Muscle Invasive Bladder Neoplasms | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BladMetrix urine test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- BladMetrix Positive NMIBC Cohort
- description
- Single cohort patients with a histologically confirmed NMIBC and a positive molecular urine marker test (BladMetrix) at the time of transurethral resection, prospectively followed at participating Norwegian hospitals with standard surveillance and parallel BladMetrix urine testing to assess recurrence
- interventionNames
- Diagnostic Test: BladMetrix urine test
Primary outcomes (1)
- measure
- Diagnostic accuracy of BladMetrix versus white light cystoscopy for detecting histologically confirmed bladder cancer recurrence
- timeFrame
- From first post TURB follow-up visit until end of urine sampling at 24 months after inclusion, with clinical follow-up for an additional 12 months to capture any recurrences occurring after the last urine sample
- description
- Sensitivity, specificity, positive predictive value, and negative predictive value of the BladMetrix urine test for detection of bladder cancer recurrence, using histologically confirmed recurrence as the reference standard. The primary comparison is between BladMetrix and white light cystoscopy alone; additional comparisons with urine cytology will also be reported.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified non muscle invasive bladder cancer (NMIBC). * Positive pre-TURB BladMetrix test. * Planned outpatient follow-up at a participating hospital, with or without intravesical instillation therapy. * Age ≥ 18 years. * Able and willing to provide written informed consent and comply with study procedures, including repeated urine sampling. Exclusion Criteria: * NMIBC planned for radical treatment (for example, immediate cystectomy). * Judged by the investigator as unlikely to be able to adhere to the follow\_up schedule or provide required urine samples. * Known cancer of the upper urinary tract at inclusion. * Patients with permanent indwelling bladder catheter (for practical reasons in optimal urine sampling)
References
Publications (3)
- BACKGROUNDVedeld HM, Pharo H, Sorbo AK, Brandt-Winge S, Five MB, Jeanmougin M, Guldberg P, Wahlqvist R, Lind GE. Distinct longitudinal patterns of urine tumor DNA in patients undergoing surveillance for bladder cancer. Mol Oncol. 2024 Nov;18(11):2684-2695. doi: 10.1002/1878-0261.13639. Epub 2024 May 8. PMID 38720532
- BACKGROUNDPharo HD, Jeanmougin M, Ager-Wick E, Vedeld HM, Sorbo AK, Dahl C, Larsen LK, Honne H, Brandt-Winge S, Five MB, Monteiro-Reis S, Henrique R, Jeronimo C, Steven K, Wahlqvist R, Guldberg P, Lind GE. BladMetrix: a novel urine DNA methylation test with high accuracy for detection of bladder cancer in hematuria patients. Clin Epigenetics. 2022 Sep 17;14(1):115. doi: 10.1186/s13148-022-01335-2. PMID 36115961
- BACKGROUNDAndersson E, Dahmcke CM, Steven K, Larsen LK, Guldberg P. Filtration Device for On-Site Collection, Storage and Shipment of Cells from Urine and Its Application to DNA-Based Detection of Bladder Cancer. PLoS One. 2015 Jul 7;10(7):e0131889. doi: 10.1371/journal.pone.0131889. eCollection 2015. PMID 26151138