BladMetrix Urine Test for Monitoring Recurrence in Non-Muscle Invasive Bladder Cancer

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.

NCT Number	NCT07511517
Lead Sponsor	Oslo University Hospital Collaborators: University Hospital, Akershus, Haukeland University Hospital, St. Olavs Hospital, Vestfold Hospital Trust (SiV), University Hospital of North Norway, Clinical Therapy Research in the specialist health services, The Research Council of Norway, CellCap Solutions ApS - provides the filtration device used for urine sample collection and subsequent storage in this study, South-Eastern Norway Regional Health Authority
Conditions	Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Bladder
Enrollment	500 participants
Start Date	2019-10-03
Primary Completion	2026-06 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-04-09