Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06020807

Enrollment

168

Registered

2023-09-01

Start date

2019-09-05

Completion date

2020-01-08

Last updated

2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma

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 cancer.

Interventions

DIAGNOSTIC_TESTBladder EpiCheck

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Specificity	Day 1	The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026