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

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.

Study Overview

• Status: Completed
• Conditions: Non Muscle Invasive Bladder Cancer; Non-Muscle Invasive Bladder Urothelial Carcinoma
• Intervention / Treatment: Diagnostic test: Bladder EpiCheck

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy; Healthy subjects and urology patients without prior history or evidence of bladder cancer	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nucleix Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): January 8, 2020

Study Registration Dates

• First Submitted: August 26, 2023
• First Submitted That Met QC Criteria: August 26, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
• Other Study ID Numbers: UC-Bladder EpiCheck-FDA-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No