Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

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.

Eligibility

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.

Conditions2

Locations4 sites

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