RecruitingPhase 2NCT05796375

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

Sponsor

White River Junction Veterans Affairs Medical Center

Enrollment

240 participants

Start Date

Nov 17, 2023

Study Type

INTERVENTIONAL

Conditions

Non Muscle Invasive Bladder Cancer

Summary

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

Min Age: 18 Years

Inclusion Criteria8

Aged 18 years or older
History of low grade intermediate-risk non-muscle invasive bladder cancer, defined as most recent pathology report showing any of the following:
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
Stated willingness to comply with all study procedures and availability for the duration of the study
No evidence for recurrence at cystoscopy ≤6 months after most recent tumor resection
Ability to consent in English or Spanish

Exclusion Criteria7

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.
History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of recurrent upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion)
Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).
Inability to provide a voided urine sample.

Interventions

PROCEDURECystoscopy

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

DIAGNOSTIC_TESTBladder EpiCheck urine 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.

DIAGNOSTIC_TESTXpert Bladder Cancer Monitor urine 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.