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.
CREDIBLE
Cystoscopic REDuction In BLadder Evaluations for Microhematuria - A Prospective Randomized, Controlled, Clinical Utility Study for Evaluation of Microhematuria (The CREDIBLE Study)
1 other identifier
interventional
1,000
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Typical duration for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedStudy Start
First participant enrolled
April 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
November 10, 2025
November 1, 2025
1.7 years
April 21, 2024
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cystoscopy rate
Difference in the proportion of cystoscopies performed in each arm.
3 months from the decision to perform or not perform cystoscopy.
Secondary Outcomes (1)
Rate of imaging procedures
3 months from the decision to perform or not perform cystoscopy.
Other Outcomes (6)
Detection of urothelial carcinoma (UC)
At the end of the current investigation, i.e. when a diagnosis was made or it was decided not to perform diagnostic procedures other than surveillance. Expected within approximately 120 days after sampling.
Cxbladder Triage Plus performance and test negative rate.
At the end of the current investigation, i.e. when a diagnosis was made.
Persistent hematuria.
At urinalysis 90-180 days (of the decision to proceed with surveillance)
- +3 more other outcomes
Study Arms (2)
Test Arm
EXPERIMENTALThe 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.
Control arm
NO INTERVENTIONNeither 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Urology Associates of Mobile
Mobile, Alabama, 36608, United States
Advanced Urology Institute - Daytona Beach
Daytona Beach, Florida, 32114, United States
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, 46410, United States
Southern Urology
Lafayette, Louisiana, 70508, United States
Chesapeake Urology Research Associates
Hanover, Maryland, 21076, United States
Summit Health
Voorhees Township, New Jersey, 08043, United States
Albany MED Health System
Albany, New York, 12208, United States
Integrated Medical Professionals
New York, New York, 11042, United States
Premier Medical Group of the Hudson Valley, P. C.
Poughkeepsie, New York, 12601, United States
Penn State Medical Center, Urology Research
Hershey, Pennsylvania, 17033, United States
Urology Associates, P. C.
Nashville, Tennessee, 37209, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tony Lough, PhD
Pacific Edge Limited
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2024
First Posted
May 1, 2024
Study Start
April 29, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share