Testing a non-invasive urine test for bladder cancer in veterans with blood in urine

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

This study is testing a new urine test to see if it can help veterans with blood in their urine find out if they have bladder cancer without needing invasive procedures.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: Pacific Edge Limited (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 4 sites (Murrieta, California and 3 other locations)
• Trial ID: NCT05889195 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate the Cxbladder Detect-plus test as a non-invasive diagnostic tool for veterans presenting with microscopic hematuria. Up to 1000 subjects will be enrolled from Veterans Affairs Medical Centers, where they will provide a urine sample prior to undergoing cystoscopy. The study seeks to determine if this urine test can effectively rule out bladder cancer in patients with low disease probability and identify those at higher risk, potentially reducing the need for invasive procedures. The results of the Cxbladder test will not be reported to subjects or physicians.

Who should consider this trial

Good fit: Ideal candidates are veterans aged 18 and older who have been referred for cystoscopy due to confirmed microscopic hematuria.

Not a fit: Patients with a prior history of bladder malignancy or visible blood in urine within the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive and more accurate method for detecting bladder cancer in patients with microscopic hematuria.

How similar studies have performed: Other studies have explored non-invasive tests for bladder cancer detection, but the specific application of Cxbladder in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

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:

   EITHER: (a) Microscopic hematuria, confirmed by urine microscopy of three or more RBC/HPF (or equivalent). OR: (b) Gross hematuria.
2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
3. Able to give informed, written consent.
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. Aged 18 years or older.

Footnotes:

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.
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

Exclusion Criteria:

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

Where this trial is running

Murrieta, California and 3 other locations

• Tri Valley Urology Medical Group — Murrieta, California, United States (Recruiting)
• AccuMed Research Associates — Garden City, New York, United States (Recruiting)
• Durham VA Health Care System — Durham, North Carolina, United States (Recruiting)
• The Urology Place — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Ash Maharjan, PhD

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