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

Nucleix

Status: Completed

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

Treatments: Diagnostic Test: Bladder EpiCheck

Study type: Observational

Funder types: Industry

Identifiers

NCT06020807

UC-Bladder EpiCheck-FDA-02

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

168 participants in 1 patient group

Healthy

Description:

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

Treatment:

Diagnostic Test: Bladder EpiCheck