Clinical trial · Observational
Bladder EpiCheck Product Development Study
Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies
NCT07514143CI-TRIAL-00107505recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, observational study to support the development of the Bladder EpiCheck kit by collecting urine samples from subjects suspected to have a bladder tumor or under NMIBC surveillance. This is a single visit study. Each subject will sign the informed consent and provide voided urine sample. Demography and, if performed, pathology information will be collected for each subject.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NMIBC Surveillance | — | UNRESOLVED | — |
| Suspicion of Bladder Cancer | Bladder Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bladder EpiCheck | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Subjects planned to undergo TURBT due to suspected or detected bladder tumor
- description
- Adult subjects planned to undergo TURBT within 60 days due to suspected or detected bladder tumor (e.g., by cystoscopy, cytology, imaging) will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing.
- interventionNames
- Diagnostic Test: Bladder EpiCheck
- label
- Subjects planned to undergo cystoscopy under general anesthesia due to suspected bladder tumor
- description
- Adult subjects planned to undergo cystoscopy under general anesthesia ,within 60 days due to suspected bladder tumor will be enrolled. Voided urine will be collected prior to the procedure and sent to a central lab to perform blinded Bladder EpiCheck testing.
- interventionNames
- Diagnostic Test: Bladder EpiCheck
- label
- Subjects planned to undergo cystoscopy for NMIBC surveillance
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 22 or older 2. Willing and able to sign the informed consent form 3. Subject(s) that is planned to undergo ,within 60 days, one of the following procedures: 3.1 TURBT due to suspected or detected bladder tumor, or 3.2 Cystoscopy under general anesthesia due to suspected bladder tumor, or 3.3 Cystoscopy for NMIBC surveillance Exclusion Criteria: 1. Patients with known or history of muscle invasive bladder cancer (MIBC) 2. Treatment of prostate cancer or RCC in the past 2 years 3. Patients previously enrolled into this study within the prior 60 days
References
Publications (0)
Data not yet available
No reference posted for this study.