Clinical trial NCT05796375: Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
Official title: Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-muscle-invasive Bladder Cancer
Keywords: Bladder
Cancer
Urology
Cystoscopy
Xpert
EpiCheck
Urine test
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: National Cancer Institute (NCI)
name: University of Texas Southwestern Medical Center
name: Medical University of South Carolina
First posted: 2023-04-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Health care delivery parallel trial with 1:1:1 randomization
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: This is a multi-site randomized phase 2 trial including 240 patients with early-stage bladder cancer, in which patients will be randomized 1:1:1 to programmatic surveillance with the Xpert bladder cancer urine test, the Bladder EpiCheck urine test, or frequent cystoscopy. The primary outcome will be urinary quality of life measured 1 to 3 days after surveillance.

This study will have three groups, also called "arms": (1) Frequent Cystoscopy Arm, (2) Xpert Urine Test Arm, and (3) Epicheck Urine Test Arm. The aim of Frequent Cystoscopy is to detect any cancer that might have come back within the bladder by frequently inspecting the bladder. Those in the cystoscopy arm will have a cystoscopy procedure at specified time points for two years. The goal of the Xpert Urine Test arm is to detect any cancer that might have come back within the bladder, while decreasing the number of invasive cystoscopy procedures. Those in the Xpert arm will have a Xpert urine test and a check-up with a medical doctor at 6 months and 18 months, and have a cystoscopy procedure at 12 months and 24 months. The aim of the EpiCheck Urine Test arm is to detect any cancer that might have come back within the bladder, while decreasing the number of invasive cystoscopy procedures. Those in the EpiCheck Urine Test arm will have an Epicheck urine test and a check-up with a medical doctor at 6 months and 18 months and will have a cystoscopy procedure at 12 months and 24 months. The study performance period is 24 months.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older
2. 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
3. Stated willingness to comply with all study procedures and availability for the duration of the study
4. No evidence for recurrence at cystoscopy ≤4 months after most recent tumor resection
5. Ability to consent in English or Spanish

Exclusion Criteria:

1. History of total cystectomy of the bladder.
2. History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit).
3. History of muscle-invasive bladder tumor.
4. Pregnancy or lactation.
5. 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)
6. Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).
7. Inability to provide a voided urine sample.

Primary outcomes:
measure: Quality of Life Questionnaire-Non-Muscle Invasive Bladder Cancer 24 (EORTC QLQ-NMIBC24)
timeFrame: Assessed at 3, 6, 12, 18, and 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: West Roxbury
country: United States
facility: VA Boston Jamaica Plains Campus
state: Massachusetts
city: St. Louis
country: United States
facility: VA St.Louis Healthcare System
state: Missouri
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: White River Junction
country: United States
facility: White River Junction Veterans Healthcare System
state: Vermont
Study officials:
affiliation: White River Junction VA Healthcare System
name: Florian R Schroeck, MD, MS
role: PRINCIPAL_INVESTIGATOR
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