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OpenTrials
Completed

NCT Number: NCT06020807

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.

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Key information

Conditions

Non Muscle Invasive Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Non-Muscle Invasive Bladder Urothelial Carcinoma Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Urology San Antonio

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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.

Primary outcomes

  1. Specificity

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

Nucleix Ltd.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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