Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
Study Details
Study Description
Brief 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). 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Arm A: CxBladder followed by cystoscopy Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter |
Diagnostic Test: CxBladder Monitor
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.
Other Names:
Diagnostic Test: Cystoscopy
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.
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| Arm B: cystoscopy followed by CxBladder Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter. |
Diagnostic Test: CxBladder Monitor
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.
Other Names:
Diagnostic Test: Cystoscopy
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.
|
Outcome Measures
Primary Outcome Measures
- Preference for CxBladder Monitor compared to cystoscopy [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).
Secondary Outcome Measures
- Patient satisfaction [Up to 6 months]
Patient satisfaction will be assessed based on the Satisfaction Questionnaire (SQ) after completion of each test at 3 and 6 months.
- European Organisation for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC-QLQ C30) [Up to 6 months]
The European Organisation for Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ C30) will be used to assess Health-related quality of life. The questionnaire consists of 30 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 on functioning scales and global health status represent better functioning, while higher scores on the symptom scales indicate more symptom burden.
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer (EORTC QLQ NMIBC-24) [Up to 6 months]
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.
- Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF) [Up to 6 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female with a history of histologically confirmed stage 0 (Ta and/or CIS) nonmuscle invasive bladder cancer who have at least 9 months of disease-free survival from last recurrence.
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Able to provide urine for testing and comply with study protocol.
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Have an email address and be willing to complete surveys online.
Exclusion Criteria:
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History of non-urothelial bladder cancer (primary squamous, adenocarcinoma, and small cell carcinoma)
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Patients with predominant (>50%) variant histology
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Patients with a history of upper tract and/or urethral cancer
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Patients with a history of T1 NMIBC
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Women who are pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
| 2 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224 |
| 3 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Mark D. Tyson, M.D., M.P.H., Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-008567
- MDT-CxB-01
- NCI-2023-09278