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Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance

ConditionNon-muscle-invasive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWhite River Junction Veterans Affairs Medical Center

About this trial

The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing. Specifically, this study examines whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older

multifocal low grade non-invasive urothelial carcinoma of any size

solitary low grade non-invasive urothelial carcinoma greater than 3cm in size

recurrent low grade non-invasive urothelial carcinoma

Disqualifiers

History of total cystectomy of the bladder.

History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit).

History of muscle-invasive bladder tumor.

Pregnancy or lactation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cystoscopy

    Procedure/Surgery

    Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.

  • Bladder EpiCheck urine test

    Diagnostic test

    The Bladder EpiCheck is a laboratory-developed test for early-stage non-muscle invasive bladder cancer. The Bladder EpiCheck test is a DNA methylation test that is run on DNA extracted from cell pellet from centrifuged urine according to Standardized Operating Procedures. The test has internal controls and a dedicated software to ensure required quality assurance processes and prompt reporting of results.

  • Xpert Bladder Cancer Monitor urine test

    Diagnostic test

    A 4.5 ml sample of voided urine is added to Xpert® Urine Transport Reagent, mixed, and then 4ml of treated urine are transferred to the Sample Chamber of the cartridge. In the cartridge, cells in the urine sample are captured on a filter and lysed by sonication. The released nucleic acid is eluted, mixed with dry RT-PCR reagents, and the solution is transferred to the reaction tube for RT-PCR and detection.

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: Frequent CystoscopyActive comparator 1 intervention
Group B: Xpert Urine TestExperimental treatment 2 interventions
Group C: EpiCheck Urine TextExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Quality of Life Questionnaire-Non-Muscle Invasive Bladder Cancer 24 (EORTC QLQ-NMIBC24)

Measuring change from baseline. Score range: 0-100. Lower score indicates higher quality of life.

Time frame
Assessed at 3, 6, 12, 18, and 24 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

White River Junction Veterans Affairs Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

University of Texas Southwestern Medical Center

Collaborator

Medical University of South Carolina

Collaborator

Source ClinicalTrials.gov
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