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

Completed

• Conditions: Non-Muscle Invasive Bladder Urothelial Carcinoma; Non Muscle Invasive Bladder Cancer

• Registration Number: NCT06020807
• Lead Sponsor: Nucleix Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-05
• Primary Completion: 2020-01-08
• Study Completion: 2020-01-08
• Study First Submitted: 2023-08-26
• Study First Submitted QC: 2023-08-26
• Status Verified: 2023-09
• Study First Posted: 2023-09-01
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specificity	Day 1	The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.

Trial Locations

Locations (1)

Urology San Antonio; 🇺🇸 San Antonio, Texas, United States