RecruitingNot ApplicableNCT06394869

Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.

Cystoscopic REDuction In BLadder Evaluations for Microhematuria - A Prospective Randomized, Controlled, Clinical Utility Study for Evaluation of Microhematuria (The CREDIBLE Study)


Sponsor

Pacific Edge Limited

Enrollment

1,000 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria. One of them is bladder cancer. While bladder cancer is one of the biggest worries, it is only found in few of these patients. Most microhematuria patients will have a cystoscopy to look inside the bladder. During a cystoscopy, a small camera is inserted into the bladder. This is done through the urethra, the tube that passes urine from the bladder to the outside. In some patients it can cause pain or anxiety. Not all patients have a cystoscopy. Those that don't, usually return for a urine sample within 6 months. This is done to check if there is still blood in their urine. This study is conducted to find out if the use of "Cxbladder Triage Plus" changes the number of cystoscopies in microhematuria patients. Cxbladder Triage Plus is also called "Triage Plus". It is a lab test that was developed to check how likely urothelial carcinoma is present in the bladder. Urothelial carcinoma is by far the most common type of bladder cancer. For the test, the patient voids some urine into a cup. A laboratory then checks the urine of specific genetic material. Abnormalities can be a sign of urothelial carcinoma. The result indicates if the urine is more like most normal urine or more like that of urothelial carcinoma patients. The study is done to find out how Triage Plus changes the number of cystoscopies. Study participants first void urine into a cup. The urine is used for the Triage Plus test. The patients are then assigned to one of two groups. The assignment is random. This means the nobody can influence the assignment. The chance to be assigned to either group is the same. In the test group, the urologist will receive the Triage Plus result and discuss it with the patient. Together they decide whether to do a cystoscopy. In the control group, the urologist will not receive the Triage Plus result. The patient will also not get the result. The urologist and patient will follow standard of care to decide whether to do a cystoscopy. For test group patients, the study gives a recommendation whether to proceed with cystoscopy. It is based on the patient's Triage Plus result. The urologist and patient do not need to follow the recommendation. If the urologist does not follow it, they will complete a survey. The survey has only one question. It is asking for the reasons of the decision. After making their decision, patients will follow the chosen pathway. Data on the performed procedures are collected. The diagnosis will also be documented. Data will be collected for up to about 9 months. To see how Triage Plus changes the number of cystoscopies, these will be counted in each group and then compared.


Eligibility

Min Age: 18 YearsMax Age: 88 Years

Inclusion Criteria6

  • Patient is referred for assessment of microhematuria (MH) with presentation confirmed by urine microscopy of 3 or more red blood cells per high powered field (RBC/HPF) (documented by the referring physician or at the investigator site) within 6-months of enrollment.
  • 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.
  • Must be 19 or the legal age of consent in the jurisdiction in which the study is taking place to 88 years of age inclusive, at the time of signing the informed consent.
  • Ability to comprehend written and spoken English sufficiently to independently follow all study procedures. Or ability to comprehend Spanish with access to an English-Spanish interpreter for all study related verbal instructions and discussions.

Exclusion Criteria11

  • Prior history of bladder malignancy.
  • Prior history of upper tract UC or prostatic urethral UC.
  • Gross hematuria within the last twelve months (reported in patient's records and/or during patient's interview)
  • Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)
  • Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatic hyperplasia symptoms and desires a procedure, weak stream with concerns for urethral stricture).
  • Cystoscopy contraindicated due to another condition or anatomy.
  • History of pelvic radiation.
  • Currently receiving systemic chemotherapy or has had systemic chemotherapy within the last 6 weeks.
  • History of schistosomiasis.
  • History of chronic (\>3 months) indwelling Foley catheter or chronic (\>3 months) bladder stones.
  • Known current pregnancy

Interventions

DIAGNOSTIC_TESTCxbladder Triage Plus

Cxbladder Triage Plus is a lab developed, test that is using RNA and DNA biomarkers in the urine to assess the likelihood of the presence of urothelial carcinoma in the bladder.


Locations(15)

Urology Centers of Alabama

Homewood, Alabama, United States

Urology Associates of Mobile

Mobile, Alabama, United States

Advanced Urology Institute - Daytona Beach

Daytona Beach, Florida, United States

Urologic Specialists of Northwest Indiana

Merrillville, Indiana, United States

Southern Urology

Lafayette, Louisiana, United States

Chesapeake Urology Research Associates

Hanover, Maryland, United States

Summit Health

Voorhees Township, New Jersey, United States

Albany MED Health System

Albany, New York, United States

Integrated Medical Professionals

New York, New York, United States

Premier Medical Group of the Hudson Valley, P. C.

Poughkeepsie, New York, United States

Penn State Medical Center, Urology Research

Hershey, Pennsylvania, United States

Urology Associates, P. C.

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06394869