Clinical trial · Observational
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
NCT06020807CI-TRIAL-00069372completedClinicalTrials.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 study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.
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 |
|---|---|---|---|
| Non Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
| Non-Muscle Invasive Bladder Urothelial Carcinoma | Non-Muscle Invasive Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bladder EpiCheck | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Healthy
- description
- Healthy subjects and urology patients without prior history or evidence of bladder cancer
- interventionNames
- Diagnostic Test: Bladder EpiCheck
Primary outcomes (1)
- measure
- Specificity
- timeFrame
- Day 1
- description
- The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Age 22 or older * Able to sign the informed consent form * Normal, healthy subjects or subjects with one of the following conditions: 1. Benign non-genitourinary disease (e.g. heart disease) 2. Non-genitourinary cancers (e.g. lung, CRC, breast) 3. Genitourinary disease other than bladder cancer including: 4. Benign prostatic hyperplasia (BPH) 5. Microhematuria proven negative for bladder cancer through prior UCC evaluation 6. Inflammation/infection 7. Symptomatic sexually transmitted disease (STD) 8. Urinary tract stones 9. Genitourinary trauma * Subjects with native bladder Exclusion Criteria: * Known current or prior diagnosis of bladder cancer (non-muscle or muscle invasive) * Currently in work-up due to suspicion of cancer of any kind
References
Publications (0)
Data not yet available
No reference posted for this study.