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

Non-muscle Invasive Bladder Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126796
• Other study ID #: MDT-CxB-01
• Secondary ID: 23-008567NCI-202
• Status: Recruiting
• Start date: November 16, 2023
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 107
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female with a history of histologically confirmed stage 0 [Ta and/or carcinoma in situ (CIS)] 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.

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

Related Conditions & MeSH terms

• NMIBC
• Non-muscle Invasive Bladder Cancer
• Stage 0a Bladder Cancer AJCC v8
• Urinary Bladder Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	Up to 6 months
Secondary	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
Secondary	Financial costs	Assessed by patient responses to questions about missed work and time missed from usual activities.	Up to 6 months
Secondary	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.	Up to 6 months

External Links

•   Mayo Clinic Clinical Trials