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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Planned participants: 500
• From 3 Oct 2019 to the primary completion date, 30 Jun 2026
• 6 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

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