The Burden of Cystoscopic Bladder Cancer Surveillance: Anxiety, Discomfort, and Patient Preferences for Decision Making.
Kevin Koo, Lisa Zubkoff, Brenda E Sirovich...
https://pubmed.ncbi.nlm.nih.gov/28739405Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05796375
Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
Led by White River Junction Veterans Affairs Medical Center · Updated on 2026-05-04
240
Participants Needed
9
Research Sites
4 weeks
Total Duration
On this page
Sponsors
W
White River Junction Veterans Affairs Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether bladder cancer monitoring can be improved by replacing some invasive cystoscopy procedures with urine testing in patients with early-stage non-muscle invasive bladder cancer. This phase 2 randomized trial compares the effects on urinary symptoms, discomfort, invasive procedures, anxiety, complications, cancer recurrence, and progression among different surveillance methods. Participants are randomly assigned to one of three groups: frequent cystoscopy, Xpert bladder cancer urine testing, or Bladder EpiCheck urine testing. Those in the frequent cystoscopy group undergo cystoscopy at 6, 12, 18, and 24 months. The Xpert and EpiCheck groups have urine tests and medical check-ups at 6 and 18 months, with cystoscopy at 12 and 24 months. The study lasts 24 months. During the study, participants will complete quality of life questionnaires focused on urinary health at 3, 6, 12, 18, and 24 months. Researchers will assess urinary symptoms, discomfort, anxiety, complications, and cancer outcomes. The primary measurement is the Quality of Life Questionnaire-Non-Muscle Invasive Bladder Cancer 24 (EORTC QLQ-NMIBC24). Participants will be monitored throughout the two-year study period.
CONDITIONS
Brief Title
Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- History of low grade intermediate-risk non-muscle invasive bladder cancer, including multifocal low grade non-invasive urothelial carcinoma of any size, solitary low grade non-invasive urothelial carcinoma greater than 3 cm, or recurrent low grade non-invasive urothelial carcinoma
- Willingness to comply with all study procedures and availability for the duration of the study
- No evidence of recurrence at cystoscopy within 6 months after most recent tumor resection
- Ability to consent in English or Spanish
You will not qualify if you...
- History of total cystectomy of the bladder
- History of urinary diversion such as 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 with recurrent upper tract disease unless status post nephroureterectomy and recurrence free
- Anatomic constraints preventing cystoscopy, such as urethrectomy or obliterated urethra due to stricture
- Inability to provide a voided urine sample
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surveillance
Duration - 24 months
Participants undergo surveillance using one of three methods: frequent cystoscopy, urine testing with the Xpert Bladder Cancer Monitor combined with cystoscopy at specific times, or urine testing with the Bladder EpiCheck combined with cystoscopy at specific times to detect any cancer recurrence.
Cystoscopy visits at 6, 12, 18, and 24 months for the Frequent Cystoscopy arm; urine tests and doctor check-ups at 6 and 18 months plus cystoscopy at 12 and 24 months for the Xpert Urine Test arm; urine tests and doctor check-ups at 6 and 18 months plus cystoscopy at 12 and 24 months for the EpiCheck Urine Test arm
Trial Site Locations
Total: 9 locations
1
West Haven VA Medical Center
West Haven, Connecticut, United States, 06516
Actively Recruiting
2
Bay Pines VA Healthcare System
Bay Pines, Florida, United States, 33744
Actively Recruiting
3
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33612
Actively Recruiting
4
VA Boston Jamaica Plains Campus
West Roxbury, Massachusetts, United States, 02132
Actively Recruiting
5
VA St.Louis Healthcare System
St Louis, Missouri, United States, 63016
Actively Recruiting
6
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
7
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Active, Not Recruiting
8
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
9
White River Junction Veterans Healthcare System
White River Junction, Vermont, United States, 05009
Actively Recruiting
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Research Team
P
Prabhavathi Loganathan, MS
L
Laura Jensen, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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Published Research Related To This Trial
The impact of frequent cystoscopy on surgical care and cancer outcomes among patients with low-risk, non-muscle-invasive bladder cancer.
Florian R Schroeck, Kristine E Lynch, Zhongze Li...
https://pubmed.ncbi.nlm.nih.gov/31120559Clinical Trial Protocol for "Replace Cysto": Replacing Invasive Cystoscopy with Urine Testing for Non-muscle-invasive Bladder Cancer Surveillance-A Multicenter, Randomized, Phase 2 Healthcare Delivery Trial Comparing Quality of Life During Cancer Surveillance with Xpert Bladder Cancer Monitor or Bladder EpiCheck Urine Testing Versus Frequent Cystoscopy.
Florian R Schroeck, Robert Grubb, Todd A MacKenzie...
https://pubmed.ncbi.nlm.nih.gov/38558761