Status:
COMPLETED
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
Lead Sponsor:
Nucleix Ltd.
Conditions:
Non Muscle Invasive Bladder Cancer
Non-Muscle Invasive Bladder Urothelial Carcinoma
Eligibility:
All Genders
22+ years
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 8 2020
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06020807
Start Date
September 5 2019
End Date
January 8 2020
Last Update
September 7 2023
Active Locations (1)
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1
Urology San Antonio
San Antonio, Texas, United States, 78229