RECRUITING

Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen with the naked eye). This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low in this population group, approximately 3%. Invasive procedures such as cystoscopy can cause anxiety and pain, in addition to other potential side effects. This has resulted in low admittance for cystoscopy among patients with hematuria (blood in urine) in urology clinics. Therefore, there is a need for a simpler, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. Cxbladder, a non-invasive, urine-based test, has the potential to fill this role.

Official Title

Validation of Cxbladder Triage-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria (microDRIVE)

Quick Facts

Study Start:2023-11-02
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05889195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects who are referred to urology and are either scheduled for a cystoscopy or have had a cystoscopic investigation within the last two months for the evaluation of hematuria meeting ONE of the following criteria:
  2. 2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
  3. 3. Able to give informed, written consent.
  4. 4. Able and willing to comply with study requirements (complete at-home urine sampling, fill in test request forms (TRFs) / tube labels and ship urine back to the central laboratory using a prepaid courier service).
  5. 5. Aged 18 years or older.
  6. 1. For the microscopic hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder. ii) Patients who are considered high risk by the AUA 2020 guidelines.
  7. 2. For gross hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder
  1. 1. Prior history of bladder malignancy.
  2. 2. Reported Cxbladder results within the last six months.
  3. 3. Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC.
  4. 4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch).
  5. 5. Subjects aged 89 years of age or older.
  6. 6. Subjects with a history of pelvic radiation.
  7. 7. Subjects currently receiving systemic chemotherapy or has had systemic chemotherapy within the last six weeks.
  8. 8. Subjects with renal failure on dialysis.
  9. 9. History of schistosomiasis.
  10. 10. Subjects who have had intervention (TURBT, diathermia, etc.,) following a previous cystoscopy.

Contacts and Locations

Study Contact

Ash Maharjan, PhD
CONTACT
+64 27 318 0613
ash.maharjan@pelnz.com
Alexis White, BSc (Hons)
CONTACT
+64 21 959 001
alexis.white@pelnz.com

Principal Investigator

Tony Lough, PhD
STUDY_CHAIR
Pacific Edge (Australia) Pty Ltd

Study Locations (Sites)

Tri Valley Urology Medical Group
Murrieta, California, 92562
United States
AccuMed Research Associates
Garden City, New York, 11530
United States
Durham VA Health Care System
Durham, North Carolina, 27705
United States
The Urology Place
San Antonio, Texas, 78240
United States

Collaborators and Investigators

Sponsor: Pacific Edge Limited

  • Tony Lough, PhD, STUDY_CHAIR, Pacific Edge (Australia) Pty Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-11-02
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Urothelial Carcinoma
  • microscopic hematuria
  • Cxbladder
  • Urine test
  • genomic test

Additional Relevant MeSH Terms

  • Urothelial Carcinoma