Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
Sponsored by Nucleix Ltd.
About this trial
Last updated 2 years ago
Study ID
UC-Bladder EpiCheck-FDA-02
Status
Completed
Type
Observational
Placebo
No
Accepting
22+ Years
All
Trial Timing
Ended 5 years ago
What is this trial about?
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.
What are the participation requirements?
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