Clinical trial · Interventional
Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
NCT05796375CI-TRIAL-00120655ReplaceCystorecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-muscle-invasive Bladder Cancer | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bladder EpiCheck urine test | Diagnostic Test | — | UNRESOLVED |
| Cystoscopy | Procedure | — | UNRESOLVED |
| Xpert Bladder Cancer Monitor urine test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Frequent Cystoscopy
- description
- Cystoscopy is conducted at 6, 12, 18, and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer
- interventionNames
- Procedure: Cystoscopy
- type
- EXPERIMENTAL
- label
- Xpert Urine Test
- description
- 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
- interventionNames
- Procedure: Cystoscopy
- Diagnostic Test: Xpert Bladder Cancer Monitor urine test
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 ≤6 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.
References
Publications (3)
- BACKGROUNDKoo 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 28739405
- BACKGROUNDSchroeck 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 31120559
- BACKGROUNDSchroeck 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 38558761