Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
ReplaceCysto
3 other identifiers
interventional
240
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2023
Longer than P75 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
November 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
May 4, 2026
May 1, 2026
5 years
March 21, 2023
May 1, 2026
Conditions
Keywords
Outcome Measures
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.
Assessed at 3, 6, 12, 18, and 24 months.
Study Arms (3)
Frequent Cystoscopy
ACTIVE COMPARATORCystoscopy is conducted at 6, 12, 18, and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer
Xpert Urine Test
EXPERIMENTALXpert arm includes urine testing using the Xpert Bladder Cancer Monitor urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer
EpiCheck Urine Text
EXPERIMENTALEpiCheck arm includes urine testing using the Bladder EpiCheck urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer.
Interventions
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).
- Inability to provide a voided urine sample.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
West Haven VA Medical Center
West Haven, Connecticut, 06516, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
James A. Haley Veterans' Hospital
Tampa, Florida, 33612, United States
VA Boston Jamaica Plains Campus
West Roxbury, Massachusetts, 02132, United States
VA St.Louis Healthcare System
St Louis, Missouri, 63016, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
UT Southwestern Medical Center
Dallas, Texas, 75235, United States
White River Junction Veterans Healthcare System
White River Junction, Vermont, 05009, United States
Related Publications (3)
Koo K, Zubkoff L, Sirovich BE, Goodney PP, Robertson DJ, Seigne JD, Schroeck FR. The Burden of Cystoscopic Bladder Cancer Surveillance: Anxiety, Discomfort, and Patient Preferences for Decision Making. Urology. 2017 Oct;108:122-128. doi: 10.1016/j.urology.2017.07.016. Epub 2017 Jul 21.
PMID: 28739405BACKGROUNDSchroeck FR, Lynch KE, Li Z, MacKenzie TA, Han DS, Seigne JD, Robertson DJ, Sirovich B, Goodney PP. The impact of frequent cystoscopy on surgical care and cancer outcomes among patients with low-risk, non-muscle-invasive bladder cancer. Cancer. 2019 Sep 15;125(18):3147-3154. doi: 10.1002/cncr.32185. Epub 2019 May 23.
PMID: 31120559BACKGROUNDSchroeck FR, Grubb R, MacKenzie TA, Ould Ismail AA, Jensen L, Tsongalis GJ, Lotan Y. Clinical 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. Eur Urol Open Sci. 2024 Mar 21;63:19-30. doi: 10.1016/j.euros.2024.02.018. eCollection 2024 May.
PMID: 38558761BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florian R Schroeck, MD, MS
White River Junction VA Healthcare System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Section of Urology
Study Record Dates
First Submitted
March 21, 2023
First Posted
April 3, 2023
Study Start
November 17, 2023
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
May 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share