NCT07511517

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2019Jun 2027

Study Start

First participant enrolled

October 3, 2019

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

6.7 years

First QC Date

March 30, 2026

Last Update Submit

April 5, 2026

Conditions

Urinary Bladder NeoplasmsCarcinoma, Transitional Cell, BladderNon-Muscle Invasive Bladder Neoplasms

Keywords

Bladder cancerNon-muscle invasive bladder cancer (NMIBC)BladMetrixUrine biomarkerUrine DNA methylationMolecular urine testMonitoring of bladder cancerRecurrence monitoringSurveillanceCystoscopyUrine cytologyDiagnostic accuracySensitivitySpecificityFollow-up

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of BladMetrix versus white light cystoscopy for detecting histologically confirmed bladder cancer recurrence

    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.

    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

Secondary Outcomes (2)

  • Comparison of BladMetrix and urine cytology for recurrence detection

    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

  • Incremental value of BladMetrix in combination with cystoscopy and cytology

    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

Study Arms (1)

BladMetrix Positive NMIBC Cohort

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

Diagnostic Test: BladMetrix urine test

Interventions

BladMetrix urine testDIAGNOSTIC_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

BladMetrix Positive NMIBC Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with non-muscle invasive bladder cancer (NMIBC) treated at participating urology departments in Norway form the study population. Participants are identified among patients undergoing transurethral resection of bladder tumor (TURB) for primary or recurrent NMIBC who have a positive BladMetrix urine test at baseline and are scheduled for guideline based outpatient surveillance at the participating hospitals. The population thus represents a real world NMIBC follow up cohort across all Norwegian health regions, including a spectrum of risk groups managed with standard cystoscopic surveillance, with or without intravesical therapy.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Patients with permanent indwelling bladder catheter (for practical reasons in optimal urine sampling)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Haukeland University Hospital

Bergen, Norway

Location

Akershus University Hospital (Ahus)

Lørenskog, Norway

Location

Oslo University Hospital - Aker

Oslo, Norway

Location

University Hospital of North Norway (UNN)

Tromsø, Norway

Location

St. Olavs Hospital - Trondheim University Hospital

Trondheim, Norway

Location

Vestfold Hospital Trust (SiV)

Tønsberg, Norway

Location

Related Publications (3)

  • Vedeld 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: 38720532BACKGROUND

  • Pharo 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: 36115961BACKGROUND

  • Andersson 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: 26151138BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Non-Muscle Invasive Bladder NeoplasmsUrinary Bladder NeoplasmsCarcinomaHypersensitivity

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesImmune System Diseases

Study Officials

  • Rolf Wahlqvist, MD, PhD

    Oslo University Hospital - Aker

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cancer Epigenetics, PhD, University of Oslo/Oslo University hospital

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 6, 2026

Study Start

October 3, 2019

Primary Completion

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. The Regional Ethics Committee (REC) approval and the informed consent form limit use of participants' data to the purposes described in this study and do not include provision for external sharing of coded participant-level data outside the participating hospitals, in accordance with Norwegian and EU data protection regulations.

Locations

NO(6)