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Completed

NCT Number: NCT06126796

Urine-based Molecular Testing vs 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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
  • Women who are pregnant

Treatment and study plan

CxBladder Monitor

Diagnostic Test

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: CxBladder, CxbM

Cystoscopy

Diagnostic 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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Patient satisfaction

    Time frame: 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.

  2. Change in symptoms and function - EORTC NMIBC-24

    Time frame: 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.

  3. Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)

    Time frame: 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.

  4. Financial costs

    Time frame: Up to 6 months

    Assessed by patient responses to questions about missed work and time missed from usual activities.

  5. Error rate identifying recurrent nonmuscle invasive bladder cancer (NMIBC)

    Time frame: Up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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