Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
Completed
- Conditions
- Non-Muscle Invasive Bladder Urothelial CarcinomaNon Muscle Invasive Bladder Cancer
- Interventions
- Diagnostic Test: Bladder EpiCheck
- Registration Number
- NCT06020807
- Lead Sponsor
- Nucleix Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
Inclusion Criteria
-
Age 22 or older
-
Able to sign the informed consent form
-
Normal, healthy subjects or subjects with one of the following conditions:
- Benign non-genitourinary disease (e.g. heart disease)
- Non-genitourinary cancers (e.g. lung, CRC, breast)
- Genitourinary disease other than bladder cancer including:
- Benign prostatic hyperplasia (BPH)
- Microhematuria proven negative for bladder cancer through prior UCC evaluation
- Inflammation/infection
- Symptomatic sexually transmitted disease (STD)
- Urinary tract stones
- Genitourinary trauma
-
Subjects with native bladder
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy Bladder EpiCheck Healthy subjects and urology patients without prior history or evidence of bladder cancer
- Primary Outcome Measures
Name Time Method Specificity Day 1 The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Urology San Antonio
🇺🇸San Antonio, Texas, United States