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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06020807
Other study ID # UC-Bladder EpiCheck-FDA-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 5, 2019
Est. completion date January 8, 2020

Study information

Verified date September 2023
Source Nucleix Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Bladder EpiCheck
Bladder EpiCheckTM (EpiCheck) is a urine test for monitoring of recurrence of NMIBC based on analysis of 15 informative DNA methylation biomarkers.

Locations

Country Name City State
United States Urology San Antonio San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Nucleix Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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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