Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Non-muscle Invasive Bladder Cancer, NMIBC, Stage 0a Bladder Cancer AJCC v8

Intervention / Treatment
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* Diagnostic Test: CxBladder Monitor
* Diagnostic Test: Cystoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Able to provide urine for testing and comply with study protocol. Have an email address and be willing to complete surveys online. Exclusion Criteria: 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 Patients with a history of T1 NMIBC Women who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A: CxBladder followed by cystoscopy<br>Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter | Diagnostic Test: CxBladder Monitor<br>* 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.<br>* Other names: CxbM;Diagnostic Test: Cystoscopy<br>* 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.<br>|
| Arm B: cystoscopy followed by CxBladder<br>Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter. | Diagnostic Test: CxBladder Monitor<br>* 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.<br>* Other names: CxbM;Diagnostic Test: Cystoscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction will be assessed based on the Satisfaction Questionnaire (SQ) after completion of each test at 3 and 6 months. | Up to 6 months | 
| European Organisation for Research and Treatment of Cancer-Core Quality of Life Questionnaire (EORTC-QLQ C30) | 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. | Up to 6 months | 
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer (EORTC QLQ 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. | 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. | Up to 6 months |