Non-Muscle Invasive Bladder NeoplasmsBladMetrixNCT07511517
BladMetrix Urine Test for Monitoring Recurrence in Non-Muscle Invasive Bladder Cancer
An observational study of Non-Muscle Invasive Bladder Neoplasms and Urinary Bladder Neoplasms, run by Oslo University Hospital at 6 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Bladder
- What is being tested?
- BladMetrix urine test
- How many people
- 500 participants
- Where
- 6 sitesNorway
- Study dates
- 3 Oct 2019to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Norway6 sites
Haukeland University Hospital
Bergen
Akershus University Hospital (Ahus)
Lørenskog
Oslo University Hospital - Aker
Oslo
Vestfold Hospital Trust (SiV)
Tønsberg
University Hospital of North Norway (UNN)
Tromsø
St. Olavs Hospital - Trondheim University Hospital
Trondheim
About this study
Official title: National Multicenter Observational Study of Urine-Based BladMetrix Monitoring for 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.
Read the detailed description
Bladder cancer is a common malignancy and one of the most resource intensive cancers to manage because many patients live for years with a high risk of recurrence. Patients included in this study have non-muscle invasive bladder cancer (NMIBC), which is typically treated with transurethral resection of the bladder tumor (TURB) and, in selected cases, intravesical therapy. Despite adequate primary treatment, a large proportion of NMIBC patients experience one or more recurrences, and a subset progress to muscle-invasive disease. Current follow-up relies on frequent cystoscopy and urine cytology, which are invasive, burdensome for patients, and costly for the health care system.
BladMetrix is a molecular urine test based on a predefined panel of 8 DNA methylation biomarkers analyzed in DNA from urinary cells. Previous studies from our group have indicated that BladMetrix can detect bladder cancer with high sensitivity and specificity both for high and low grade cancers. In this national multicenter study, we aim to evaluate the potential clinical utility of BladMetrix in routine surveillance of NMIBC. The primary objective is to determine the diagnostic accuracy of BladMetrix for histologically confirmed bladder cancer recurrence, and to compare its performance with the current standard of care, namely cystoscopy and urine cytology, alone and in combination. Patients and user representatives have been actively involved in the planning of the study to help ensure that the research questions, follow-up procedures and information materials are clinically relevant and patient centered.
This is a prospective, observational cohort study conducted at multiple urology departments across all health regions in Norway. Adult patients with histologically verified NMIBC and a positive BladMetrix urine test at the time of TURB are eligible. After inclusion, all participants continue guideline based follow-up at their local hospital, including scheduled cystoscopies and urine cytology; the study does not alter clinical management. At each planned follow-up visit for approximately 2 years, urine is collected for BladMetrix analysis in parallel with routine examinations. Urinary cells are collected using a filtration-based device provided by CellCap Solutions ApS, where cells are captured on a filter that is subsequently transferred directly into a cassette containing lysis/storage buffer, facilitating standardized handling and preservation of cellular material for downstream molecular analysis. Cystoscopy findings, cytology results, and histopathological data from any biopsies or resections, together with relevant clinical variables, are recorded in a specially designed database (Medinsight). BladMetrix analyses are performed centrally, on coded samples, and the assay is scored positive/negative according to predefined thresholds. Personnel performing the BladMetrix analyses are blinded to all clinical data and pathological data, and test results are subsequently compared with the reference data.
The primary endpoint is the ability of BladMetrix to detect histologically confirmed bladder cancer recurrence, expressed by diagnostic accuracy measures including sensitivity, specificity, positive predictive value, and negative predictive value. Secondary endpoints include comparison of BladMetrix with urine cytology alone, with cystoscopy plus cytology, and with cystoscopy performed with adjunct imaging modalities when used in clinical practice. By evaluating this DNA methylation-based urine test in a large, real world multicenter NMIBC cohort, the study aims to determine whether BladMetrix could in the future contribute to reducing the number of cystoscopies, resolving equivocal cystoscopic findings, and enabling more individualized surveillance schedules without compromising patient safety.
The study was designed and initiated in close collaboration with head clinician Rolf Wahlqvist, MD, PhD Oslo University hospital - Aker, who has provided overall clinical leadership for the multicenter NMIBC follow up program. We also acknowledge all contributing urologists, including those holding clinical responsibility at each participating hospital (see Contacts and Locations), and the dedicated study nurses. Their combined work in patient recruitment, follow-up, data collection, and trial coordination is essential for the successful conduct of this study. Finally, the user representatives have contributed with their experience to strengthen the patient centered focus of the project.
- Conditions
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Bladder
- Being tested
- BladMetrix urine test
- Keywords
- Bladder cancer, Non-muscle invasive bladder cancer (NMIBC), BladMetrix, Urine biomarker, Urine DNA methylation, Molecular urine test, Monitoring of bladder cancer, Recurrence monitoring, Surveillance, Cystoscopy, Urine cytology, Diagnostic accuracy, Sensitivity, Specificity, Follow-up
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: BladMetrix urine test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Sensitivity, specificity, positive predictive value, and negative predictive value of BladMetrix versus urine cytology alone for detecting histologically confirmed bladder cancer recurrence during follow_up.
Measured: 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
Diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of BladMetrix combined with standard surveillance (cystoscopy with or without adjunct imaging and urine cytology) for detection of histologically confirmed bladder cancer recurrence, and assessment of whether BladMetrix detects recurrence earlier than standard methods.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start3 Oct 2019
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Muscle Invasive Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Guro Elisabeth Lind, Oslo University Hospital
- Investigators
- Rolf Wahlqvist, MD, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511517
- Sponsor's protocol ID
- 28461
- Acronym
- BladMetrix
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38720532Pharo 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.
PubMed 36115961Andersson 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.
PubMed 26151138
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Multicenter Observational Study of Urine-Based BladMetrix Monitoring for Recurrence in Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07511517
- Acronym / sponsor ID
- BladMetrix / 28461
- Conditions
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Bladder
- Keywords
- Bladder cancer, Non-muscle invasive bladder cancer (NMIBC), BladMetrix, Urine biomarker, Urine DNA methylation, Molecular urine test, Monitoring of bladder cancer, Recurrence monitoring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- 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
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bladder cancer is a common malignancy and one of the most resource intensive cancers to manage because many patients live for years with a high risk of recurrence. Patients included in this study have non-muscle invasive bladder cancer (NMIBC), which is typically treated with transurethral resection of the bladder tumor (TURB) and, in selected cases, intravesical therapy. Despite adequate primary treatment, a large proportion of NMIBC patients experience one or more recurrences, and a subset progress to muscle-invasive disease. Current follow-up relies on frequent cystoscopy and urine cytology, which are invasive, burdensome for patients, and costly for the health care system.
BladMetrix is a molecular urine test based on a predefined panel of 8 DNA methylation biomarkers analyzed in DNA from urinary cells. Previous studies from our group have indicated that BladMetrix can detect bladder cancer with high sensitivity and specificity both for high and low grade cancers. In this national multicenter study, we aim to evaluate the potential clinical utility of BladMetrix in routine surveillance of NMIBC. The primary objective is to determine the diagnostic accuracy of BladMetrix for histologically confirmed bladder cancer recurrence, and to compare its performance with the current standard of care, namely cystoscopy and urine cytology, alone and in combination. Patients and user representatives have been actively involved in the planning of the study to help ensure that the research questions, follow-up procedures and information materials are clinically relevant and patient centered.
This is a prospective, observational cohort study conducted at multiple urology departments across all health regions in Norway. Adult patients with histologically verified NMIBC and a positive BladMetrix urine test at the time of TURB are eligible. After inclusion, all participants continue guideline based follow-up at their local hospital, including scheduled cystoscopies and urine cytology; the study does not alter clinical management. At each planned follow-up visit for approximately 2 years, urine is collected for BladMetrix analysis in parallel with routine examinations. Urinary cells are collected using a filtration-based device provided by CellCap Solutions ApS, where cells are captured on a filter that is subsequently transferred directly into a cassette containing lysis/storage buffer, facilitating standardized handling and preservation of cellular material for downstream molecular analysis. Cystoscopy findings, cytology results, and histopathological data from any biopsies or resections, together with relevant clinical variables, are recorded in a specially designed database (Medinsight). BladMetrix analyses are performed centrally, on coded samples, and the assay is scored positive/negative according to predefined thresholds. Personnel performing the BladMetrix analyses are blinded to all clinical data and pathological data, and test results are subsequently compared with the reference data.
The primary endpoint is the ability of BladMetrix to detect histologically confirmed bladder cancer recurrence, expressed by diagnostic accuracy measures including sensitivity, specificity, positive predictive value, and negative predictive value. Secondary endpoints include comparison of BladMetrix with urine cytology alone, with cystoscopy plus cytology, and with cystoscopy performed with adjunct imaging modalities when used in clinical practice. By evaluating this DNA methylation-based urine test in a large, real world multicenter NMIBC cohort, the study aims to determine whether BladMetrix could in the future contribute to reducing the number of cystoscopies, resolving equivocal cystoscopic findings, and enabling more individualized surveillance schedules without compromising patient safety.
The study was designed and initiated in close collaboration with head clinician Rolf Wahlqvist, MD, PhD Oslo University hospital - Aker, who has provided overall clinical leadership for the multicenter NMIBC follow up program. We also acknowledge all contributing urologists, including those holding clinical responsibility at each participating hospital (see Contacts and Locations), and the dedicated study nurses. Their combined work in patient recruitment, follow-up, data collection, and trial coordination is essential for the successful conduct of this study. Finally, the user representatives have contributed with their experience to strengthen the patient centered focus of the project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BladMetrix Positive NMIBC Cohort | – | Diagnostic Test: BladMetrix urine testSingle 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BladMetrix urine testMolecular 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 | Diagnostic test | BladMetrix Positive NMIBC Cohort |
Primary outcome
Diagnostic accuracy of BladMetrix versus white light cystoscopy for detecting histologically confirmed bladder cancer recurrence
Time frame: 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
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.
2 secondary outcomes
Comparison of BladMetrix and urine cytology for recurrence detection
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 38720532Vedeld 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.
- Background: PubMed 36115961Pharo 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.
- Background: PubMed 26151138Andersson 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Wahlqvist, MD, PhD study chair
Oslo University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Muscle Invasive Bladder Neoplasms and Urinary Bladder Neoplasms, run by Oslo University Hospital at 6 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of BladMetrix versus white light cystoscopy for detecting histologically confirmed bladder cancer recurrence (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07511517, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.