Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

Launched by PACIFIC EDGE LIMITED · Jun 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new, easier way to detect bladder cancer in veterans who have microscopic hematuria, which means they have blood in their urine that can only be seen under a microscope. Currently, the standard method to check for bladder cancer involves a procedure called cystoscopy, where a thin camera is inserted into the bladder. However, because the chance of having bladder cancer in this group is low (about 3%), many patients feel anxious about the procedure and may avoid it. The trial aims to see if a non-invasive urine test called Cxbladder can accurately identify whether or not someone has urothelial carcinoma, which is a type of bladder cancer.

To participate in this trial, individuals must be at least 18 years old and have been referred to a urology clinic for a cystoscopy due to confirmed microscopic hematuria. They should be able to provide a urine sample and follow the study's instructions, which include shipping their urine to a lab. However, those with certain medical histories, such as previous bladder cancer or visible blood in their urine recently, cannot participate. Participants will help researchers understand if this urine test can be a reliable alternative to the more invasive cystoscopy, ultimately aiming to reduce discomfort and anxiety for patients.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.