Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
NCT ID: NCT06020807
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
168 participants
OBSERVATIONAL
2019-09-05
2020-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy
Healthy subjects and urology patients without prior history or evidence of bladder cancer
Bladder EpiCheck
Bladder EpiCheckTM (EpiCheck) is a urine test for monitoring of recurrence of NMIBC based on analysis of 15 informative DNA methylation biomarkers.
Interventions
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Bladder EpiCheck
Bladder EpiCheckTM (EpiCheck) is a urine test for monitoring of recurrence of NMIBC based on analysis of 15 informative DNA methylation biomarkers.
Eligibility Criteria
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Inclusion Criteria
* 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
* Currently in work-up due to suspicion of cancer of any kind
22 Years
ALL
Yes
Sponsors
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Nucleix Ltd.
INDUSTRY
Responsible Party
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Locations
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Urology San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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UC-Bladder EpiCheck-FDA-02
Identifier Type: -
Identifier Source: org_study_id
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