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

NCT06020807 | Completed

• 1 other identifier: UC-Bladder EpiCheck-FDA-02
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Specificity

  The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.

  Day 1

Study Arms (1)

Healthy

Healthy subjects and urology patients without prior history or evidence of bladder cancer

Diagnostic Test: Bladder EpiCheck

Interventions

Bladder EpiCheck DIAGNOSTIC_TEST

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

Healthy

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy subjects and urology patients without prior history or evidence of bladder cancer will be recruited from urology group clinics.

You may qualify if:

• Age 22 or older
• Able to sign the informed consent form
• Normal, healthy subjects or subjects with one of the following conditions:
• Benign non-genitourinary disease (e.g. heart disease)
• Non-genitourinary cancers (e.g. lung, CRC, breast)
• Genitourinary disease other than bladder cancer including:
• Benign prostatic hyperplasia (BPH)
• Microhematuria proven negative for bladder cancer through prior UCC evaluation
• Inflammation/infection
• Symptomatic sexually transmitted disease (STD)
• Urinary tract stones
• Genitourinary trauma
• Subjects with native bladder

You may not qualify if:

• 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

Sponsors & Collaborators

• Nucleix Ltd.: lead

Study Sites (1)

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 1, 2023
• Study Start: September 5, 2019
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)