Non Muscle Invasive Bladder Cancer Clinical Trial
Official title:
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
Verified date | September 2023 |
Source | Nucleix Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 168 |
Est. completion date | January 8, 2020 |
Est. primary completion date | January 8, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Urology San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Nucleix Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Specificity | The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population. | Day 1 |
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