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

Summary

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

• Non-Muscle Invasive Bladder Neoplasms
• Urinary Bladder Neoplasms
• Carcinoma, Transitional Cell, Bladder

Interventions

DIAGNOSTIC_TEST

BladMetrix urine test

Molecular urine test (BladMetrix) based on a predefined panel of 8 DNA methylation biomarkers, performed at each routine follow-up visit to monitor for recurrence of non-muscle invasive bladder cancer; results are compared with cystoscopy, urine cytology, and histology but do not change standard clinical management within this study

Sponsors & Collaborators

• Oslo University Hospital - Aker

  collaborator UNKNOWN

• University Hospital, Akershus

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Vestfold Hospital Trust (SiV)

  collaborator UNKNOWN

• University Hospital of North Norway (UNN)

  collaborator UNKNOWN

• Clinical Therapy Research in the specialist health services

  collaborator UNKNOWN

• The Research Council of Norway

  collaborator OTHER

• CellCap Solutions ApS - provides the filtration device used for urine sample collection and subsequent storage in this study

  collaborator UNKNOWN

• South-Eastern Norway Regional Health Authority

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Rolf Wahlqvist, MD, PhD · Oslo University Hospital - Aker

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-03

Primary Completion

2026-06-30

Completion

2027-06-30

Countries

• Norway

Study Locations