RecruitingNot Applicable

Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

United States1,000 participantsStarted 2023-11-02

Plain-language summary

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.

Who can participate

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
✓. Able to give informed, written consent.
✓. 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).
✓. Aged 18 years or older.
✓. 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.
✓. 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

Exclusion criteria

What they're measuring

To validate the performance characteristics of Cxbladder Triage Plus in a US cohort which will consist of subjects with a recent history of hematuria and are referred to urology and scheduled for cystoscopy for the evaluation of hematuria.

Timeframe: Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure

Trial details

NCT IDNCT05889195

SponsorPacific Edge Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-05-31

Contact for this trial

Ash Maharjan, PhD

+64 27 318 0613 ash.maharjan@pelnz.com

View on ClinicalTrials.gov More Urothelial Carcinoma trials