Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

NCT05889195 | Recruiting

• 1 other identifier: CXB/2023/microDRIVE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Urothelial Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Cxbladder Triage-Plus performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.

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

Secondary Outcomes (2)

• To validate the performance characteristics and Test Negative Rate of Cxbladder Triage Plus through sub-group analysis (gross hematuria, microscopic hematuria, inflammation) for patients with a recent history of hematuria who are undergoing cystoscopy

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

• To evaluate the performance characteristics of both Cxbladder Triage Plus and Cxbladder Triage in a pooled analysis with combined results generated at other clinical sites, and to the results of other published clinical studies.

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

Interventions

Cxbladder urine test DIAGNOSTIC_TEST

Cxbladder tests uses mRNA and DNA biomarkers in the urine to direct the management of UC from diagnosis to surveillance for disease recurrence.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria (three or more red blood cells per high powered field in one urinalysis; no visible blood in the urine) and gross hematuria (visible blood in the urine) from US sites. This study will be conducted on subjects with microscopic or gross hematuria referred to urology and scheduled for cystoscopy for the investigation of urothelial carcinoma.

You may qualify if:

• 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:
• EITHER: (a) Microscopic hematuria, confirmed by urine microscopy of three or more RBC/HPF (or equivalent). OR: (b) Gross hematuria.
• 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.
• Footnotes:
• 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

You may not qualify if:

• Prior history of bladder malignancy.
• Reported Cxbladder results within the last six months.
• Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC.
• Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch).
• Subjects aged 89 years of age or older.
• Subjects with a history of pelvic radiation.
• Subjects currently receiving systemic chemotherapy or has had systemic chemotherapy within the last six weeks.
• Subjects with renal failure on dialysis.
• History of schistosomiasis.
• Subjects who have had intervention (TURBT, diathermia, etc.,) following a previous cystoscopy.

Sponsors & Collaborators

• Pacific Edge Limited: lead

Study Sites (4)

Tri Valley Urology Medical Group

Murrieta, California, 92562, United States

RECRUITING

AccuMed Research Associates

Garden City, New York, 11530, United States

RECRUITING

Durham VA Health Care System

Durham, North Carolina, 27705, United States

RECRUITING

The Urology Place

San Antonio, Texas, 78240, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Tony Lough, PhD

  Pacific Edge (Australia) Pty Ltd

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 5, 2023
• Study Start: November 2, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)