Detection and Risk Stratification in Veterans Presenting with Microscopic Hematuria

Description

It is of current debate whether the use of invasive (referring to a process that requires insertion into the body) standard of care procedures such as a cystoscopy which is a procedure to look inside the bladder using a thin camera called a cystoscope, is appropriate for use in patients with microscopic hematuria or blood in urine invisible to 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 a cystoscopy comes with anxiety and pain, in addition to other potential side effects. This has resulted in low admittance in urology clinics for cystoscopy with hematuria (blood in urine) patients. Therefore, there is a need for a more simple, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. There is a potential role Cxbladder, a non-invasive, urine based test, can fill this role.

Conditions

Urothelial Carcinoma

Study Overview

Study Details

Study overview

It is of current debate whether the use of invasive (referring to a process that requires insertion into the body) standard of care procedures such as a cystoscopy which is a procedure to look inside the bladder using a thin camera called a cystoscope, is appropriate for use in patients with microscopic hematuria or blood in urine invisible to 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 a cystoscopy comes with anxiety and pain, in addition to other potential side effects. This has resulted in low admittance in urology clinics for cystoscopy with hematuria (blood in urine) patients. Therefore, there is a need for a more simple, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. There is a potential role Cxbladder, a non-invasive, urine based test, can fill this role.

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

Detection and Risk Stratification in Veterans Presenting with Microscopic Hematuria

Condition
Urothelial Carcinoma
Intervention / Treatment

-

Contacts and Locations

Durham

Durham VA Health Care System, Durham, North Carolina, United States, 27705

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subject is referred to urology and scheduled for cystoscopy for the evaluation of microscopic hematuria after recent confirmed microscopic hematuria presentation by urine microscopy of three or more RBC/HPF.
  • 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.
  • 1. Prior history of bladder malignancy.
  • 2. Visible blood in the urine within the last six months (reported in subject's records and/ or during subject's interview).
  • 3. Reported Cxbladder results within the last six months.
  • 4. Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC.
  • 5. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch).
  • 6. Subjects aged 89 years of age or older.
  • 7. Subjects with a history of pelvic radiation.
  • 8. Subjects on any current chemotherapy or have had chemotherapy within the last six weeks.
  • 9. Subjects with renal failure on dialysis.
  • 10. History of schistosomiasis.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pacific Edge Limited,

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

Study Record Dates

2025-03