Non-muscle Invasive Bladder CancerNCT06126796
Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
An observational study of Non-muscle Invasive Bladder Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate patient-reported preference for urine based molecular testing (CxBladder Monitor) compared to cystoscopy for patients on surveillance for Nonmuscle Invasive Bladder Cancer (NMIBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer
- What is being tested?
- CxBladder Monitor and Cystoscopy
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to 8 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Male or female adult patients who are undergoing cystoscopic surveillance for NMIBC after at least 9 months of recurrence-free survival.
Who may be able to join
- Male or female with a history of histologically confirmed nonmuscle invasive bladder cancer (NMIBC) who have at least 6 months of disease-free survival from last recurrence.
- Able to provide urine for testing and comply with study protocol.
- Have an email address and be willing to complete surveys online.
Who cannot join
- History of non-urothelial bladder cancer (primary squamous, adenocarcinoma, and small cell carcinoma)
- Patients with predominant (>50%) variant histology
- Patients with a history of upper tract and/or urethral cancer
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Cross-Over Study to Evaluate Patient Preference and Satisfaction With Urine-based Molecular Testing Versus Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
The purpose of this study is to evaluate patient-reported preference for urine based molecular testing (CxBladder Monitor) compared to cystoscopy for patients on surveillance for Nonmuscle Invasive Bladder Cancer (NMIBC). Urine based molecular testing involves noninvasive testing of a urine sample for biomarkers associated with disease recurrence. Cystoscopy is an examination of the bladder and urethra using a thin tube like instrument that is inserted into the urethra.
- Conditions
- Non-muscle Invasive Bladder Cancer
- Being tested
- CxBladder Monitor, Cystoscopy
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CxBladder MonitorDiagnostic test
Also called CxBladder, CxbM
CxBladder Monitor (CxbM) is an FDA-approved genomic biomarker test specifically designed for patients undergoing surveillance for NMIBC. The non-invasive urine test quantifies 5 measured biomarker genes (MDK, HOXA13, CDC2 (CDK1), IGFBP5, CXCR2) and incorporates this information into an algorithm to detect the presence or absence of bladder cancer.
CystoscopyDiagnostic test
Cystoscopy is the most common way surveillance has been performed for NMIBC. Cystoscopy is a procedure that allows your doctor to examine the lining of your bladder and the tube that carries urine out of your body (urethra). A hollow tube (cystoscope) equipped with a lens is inserted into your urethra and slowly advanced into your bladder.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: CxBladder followed by cystoscopy | Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter Receives: Diagnostic Test: CxBladder Monitor; Diagnostic Test: Cystoscopy | |
| Arm B: cystoscopy followed by CxBladder | Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter. Receives: Diagnostic Test: CxBladder Monitor; Diagnostic Test: Cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference for CxBladder Monitor compared to cystoscopy
Patient preference will be assessed based on the Preference Questionnaire (PQ) after completion of the study cross-over period (after both methods of testing have been experienced).
Measured: Up to 6 months
Secondary outcomes (5)
Patient satisfaction
Patient satisfaction will be assessed based on the Satisfaction Questionnaire (SQ) after completion of each test at 3 and 6 months.
Measured: Up to 6 months
Change in symptoms and function - EORTC NMIBC-24
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer (EORTC NMIBC-24) will be used to assess Health-related quality of life. The questionnaire consists of 24 items scored on a four-point Likert scale ranging from 1 (not at all) to 4 (very much), with the exception of the global health status items, which employ a seven-point scale ranging from 1 (very poor) to 7 (excellent). Higher scores are interpreted as more symptom burden, with exception of the sexual function and sexual enjoyment sections, where higher scores represent better functioning.
Measured: Up to 6 months
Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)
Health-related quality of life will be assessed based on the Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF) at baseline, 3 months (within 1 week of test), and 6 months (within 1 week of test). The nine-item FCRI evaluates the presence and severity of intrusive thoughts associated with FCR. Each item is rated on a Likert scale ranging from 0 ("not at all" or "never") to 4 ("a great deal' or "all the time"). A higher score indicates higher levels of FCR.
Measured: Up to 6 months
Financial costs
Assessed by patient responses to questions about missed work and time missed from usual activities.
Measured: Up to 6 months
Error rate identifying recurrent nonmuscle invasive bladder cancer (NMIBC)
Error rate for CxBladder is defined as the proportion of patients who have a negative CxBladder at 3 months but have a recurrence identified on cystoscopy at 6 months for patients in arm A. The error rate for cystoscopy is defined as the proportion of patients who have a negative cystoscopy at 3 months but have a positive CxBladder at 6 months that is subsequently confirmed by cystoscopy for patients in arm B.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start16 Nov 2023
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark D. Tyson II, M.D., M.P.H., Mayo Clinic
- Investigators
- Mark D. Tyson, M.D., M.P.H., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126796
- Sponsor's protocol ID
- MDT-CxB-01
- Other IDs
- 23-008567, NCI-2023-09278
- Status last verified
- Jan 2026
- First submitted
- 7 Nov 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-Over Study to Evaluate Patient Preference and Satisfaction With Urine-based Molecular Testing Versus Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
- ClinicalTrials.gov ID
- NCT06126796
- Acronym / sponsor ID
- MDT-CxB-01
- Conditions
- Non-muscle Invasive Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 13 Nov 2023 (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.
The purpose of this study is to evaluate patient-reported preference for urine based molecular testing (CxBladder Monitor) compared to cystoscopy for patients on surveillance for Nonmuscle Invasive Bladder Cancer (NMIBC). Urine based molecular testing involves noninvasive testing of a urine sample for biomarkers associated with disease recurrence. Cystoscopy is an examination of the bladder and urethra using a thin tube like instrument that is inserted into the urethra.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: CxBladder followed by cystoscopy | – | Diagnostic Test: CxBladder Monitor, Diagnostic Test: CystoscopyArm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter |
| Arm B: cystoscopy followed by CxBladder | – | Diagnostic Test: CxBladder Monitor, Diagnostic Test: CystoscopyArm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female adult patients who are undergoing cystoscopic surveillance for NMIBC after at least 9 months of recurrence-free survival.
Key inclusion criteria (3 listed)
- Male or female with a history of histologically confirmed nonmuscle invasive bladder cancer (NMIBC) who have at least 6 months of disease-free survival from last recurrence.
- Able to provide urine for testing and comply with study protocol.
- Have an email address and be willing to complete surveys online.
Key exclusion criteria (4 listed)
- History of non-urothelial bladder cancer (primary squamous, adenocarcinoma, and small cell carcinoma)
- Patients with predominant (>50%) variant histology
- Patients with a history of upper tract and/or urethral cancer
- Women who are pregnant
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 |
|---|---|---|
| CxBladder MonitorAlso: CxBladder, CxbMCxBladder Monitor (CxbM) is an FDA-approved genomic biomarker test specifically designed for patients undergoing surveillance for NMIBC. The non-invasive urine test quantifies 5 measured biomarker genes (MDK, HOXA13, CDC2 (CDK1), IGFBP5, CXCR2) and incorporates this information into an algorithm to detect the presence or absence of bladder cancer. | Diagnostic test | Arm A: CxBladder followed by cystoscopy, Arm B: cystoscopy followed by CxBladder |
| CystoscopyCystoscopy is the most common way surveillance has been performed for NMIBC. Cystoscopy is a procedure that allows your doctor to examine the lining of your bladder and the tube that carries urine out of your body (urethra). A hollow tube (cystoscope) equipped with a lens is inserted into your urethra and slowly advanced into your bladder. | Diagnostic test | Arm A: CxBladder followed by cystoscopy, Arm B: cystoscopy followed by CxBladder |
Primary outcome
Preference for CxBladder Monitor compared to cystoscopy
Time frame: Up to 6 months
Patient preference will be assessed based on the Preference Questionnaire (PQ) after completion of the study cross-over period (after both methods of testing have been experienced).
5 secondary outcomes
Patient satisfaction
Time frame: Up to 6 months
Change in symptoms and function - EORTC NMIBC-24
Time frame: Up to 6 months
Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)
Time frame: Up to 6 months
Financial costs
Time frame: Up to 6 months
Error rate identifying recurrent nonmuscle invasive bladder cancer (NMIBC)
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Mark D. Tyson, M.D., M.P.H. principal investigator
Mayo Clinic
1 site 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 Cancer, run by Mayo Clinic at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Preference for CxBladder Monitor compared to cystoscopy (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.