MedTrace Logo

Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.

NCT03630926 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2019-04-26

No results posted yet for this study

Summary

This is a double-blind, study to evaluate the performance of NV-VPAC1 PCa Urine Diagnostic Test in three distinct populations being treated at the Intermountain Urology Clinic. The first population (positive control) is comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. The second population (negative control) is comprised of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). The third population (negative control) is comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.

Conditions

  • Prostate Cancer
  • Benign Prostatic Hypertrophy
  • Bladder Stones
  • Kidney Stones

Interventions

DIAGNOSTIC_TEST

NV-VPAC1 PCa Urine Diagnostic Test

The NV-VPAC1 PCa Urine Diagnostic Test is intended for use by clinicians to detect the presence of prostate cancer cells shed in voided urine of men at risk for prostate cancer.

Sponsors & Collaborators

  • NuView Diagnostics

    collaborator UNKNOWN

  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Jay Bishoff, MD · Intermountain Health Care, Inc.

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2019-08-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630926 on ClinicalTrials.gov