Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
NCT ID: NCT05796375
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2023-11-17
2028-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Frequent Cystoscopy
Cystoscopy is conducted at 6, 12, 18, and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer
Cystoscopy
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
Xpert Urine Test
Xpert 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
Cystoscopy
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
Xpert 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.
EpiCheck Urine Text
EpiCheck 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.
Cystoscopy
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
Bladder 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.
Interventions
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Cystoscopy
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
Bladder 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.
Xpert 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.
Eligibility Criteria
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Inclusion Criteria
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 ≤6 months after most recent tumor resection
5. Ability to consent in English or Spanish
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Texas Southwestern Medical Center
OTHER
Medical University of South Carolina
OTHER
White River Junction Veterans Affairs Medical Center
FED
Responsible Party
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Florian Schroeck
Chief, Section of Urology
Principal Investigators
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Florian R Schroeck, MD, MS
Role: PRINCIPAL_INVESTIGATOR
White River Junction VA Healthcare System
Locations
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West Haven VA Medical Center
West Haven, Connecticut, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
VA Boston Jamaica Plains Campus
West Roxbury, Massachusetts, United States
VA St.Louis Healthcare System
St Louis, Missouri, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
White River Junction Veterans Healthcare System
White River Junction, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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Alicia Roy
Role: primary
Anna Rosenblatt
Role: primary
Laura MacAdam, NP
Role: primary
Carley Browning
Role: primary
Imani Lucas, MPH
Role: primary
Sonobia Garrett, BSHS
Role: primary
Laura L Jensen, MPH
Role: primary
References
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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.
Schroeck 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.
Schroeck 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.
Other Identifiers
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