NCT06020807
Completed
Not Applicable
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non Muscle Invasive Bladder Cancer
- Sponsor
- Nucleix Ltd.
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Specificity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
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
Outcomes
Primary Outcomes
Specificity
Time Frame: Day 1
The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.
Study Sites (1)
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