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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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 patient will be asked to complete a survey if they don't follow the urologist's recommendation. 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 88
Healthy Volunteers: f
View:

• 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 90 days 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.

• Aged 18 to 88 years.

• 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.

Locations
United States
Alabama
Urology Centers of Alabama
RECRUITING
Homewood
Urology Associates of Mobile
RECRUITING
Mobile
Maryland
Chesapeake Urology Research Associates
RECRUITING
Hanover
New Jersey
Summit Health
RECRUITING
Voorhees Township
New York
Albany MED Health System
RECRUITING
Albany
Premier Medical Group of the Hudson Valley, P. C.
RECRUITING
Poughkeepsie
Pennsylvania
Penn State Medical Center, Urology Research
RECRUITING
Hershey
Tennessee
Urology Associates, P. C.
RECRUITING
Nashville
Vanderbilt University Medical Center
RECRUITING
Nashville
Wisconsin
University of Wisconsin-Madison
RECRUITING
Madison
Contact Information
Primary
Anke Fronius, Dr.
anke.fronius@pelnz.com
+64 (0)278393164
Backup
Tony Lough, PhD
tony.lough@pelnz.com
+64 (0)21 0223 8591
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2027-03
Participants
Target number of participants: 1000
Treatments
Experimental: Test Arm
The site will receive the Cxbladder Detect+ result and the urologist study investigator discuss it with the patient before making a shared decision whether or not to proceed with cystoscopy.
No_intervention: Control arm
Neither the site nor the patient will receive the Cxbladder Detect+ result. The decision whether or not to proceed with cystoscopy will be made following standard of care.
Related Therapeutic Areas
Sponsors
Leads: Pacific Edge Limited

This content was sourced from clinicaltrials.gov