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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06020807
• Other study ID #: UC-Bladder EpiCheck-FDA-02
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Non Muscle Invasive Bladder Cancer
• Non-Muscle Invasive Bladder Urothelial Carcinoma
• Urinary Bladder Neoplasms

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