Clinical trial NCT06394869: 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.
Official title: Cystoscopic REDuction In BLadder Evaluations for Microhematuria - A Prospective Randomized, Controlled, Clinical Utility Study for Evaluation of Microhematuria (The CREDIBLE Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematuria - Cause Not Known
Keywords: microscopic hematuria
microhematuria
urothelial carcinoma
bladder cancer
Lead sponsor: Pacific Edge Limited
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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 criteria: Inclusion Criteria:

1. 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.
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.
5. Aged 18 to 88 years.
6. 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 Criteria:

1. Prior history of bladder malignancy.
2. Prior history of upper tract UC or prostatic urethral UC.
3. Gross hematuria within the last six months (reported in patient's records and/or during patient's interview)
4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)
5. 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).
6. Cystoscopy contraindicated due to another condition or anatomy.
7. History of pelvic radiation.
8. Currently receiving chemotherapy or has had chemotherapy within the last 6 weeks.
9. History of schistosomiasis.
10. History of chronic (\>3 months) indwelling Foley catheter or chronic (\>3 months) bladder stones.
11. Known current pregnancy

Primary outcomes:
measure: Cystoscopy rate
timeFrame: 3 months from the decision to perform or not perform cystoscopy.
Secondary outcomes:
measure: Rate of imaging procedures
timeFrame: 3 months from the decision to perform or not perform cystoscopy.
Other outcomes:
measure: Detection of urothelial carcinoma (UC)
timeFrame: 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.
measure: Cxbladder Triage Plus performance and test negative rate.
timeFrame: At the end of the current investigation, i.e. when a diagnosis was made.
measure: Persistent hematuria.
timeFrame: At urinalysis 90-180 days (of the decision to proceed with surveillance)
measure: Physician rationale
timeFrame: After reviewing the Detect+ result and giving their recommendation, before cystoscopy (if applicable). Expected once and within 90 days of sampling
measure: Patient rationale
timeFrame: After discussing the Detect+ result with the investigator, before cystoscopy (if applicable). Expected once and within 90 days of sampling .
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Mobile
country: United States
facility: Urology Associates of Mobile
state: Alabama
city: Hanover
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Albany
country: United States
facility: Albany MED Health System
state: New York
city: Hershey
country: United States
facility: Penn State Medical Center, Urology Research
state: Pennsylvania
city: Nashville
country: United States
facility: Urology Associates, P. C.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Pacific Edge Limited
name: Tony Lough, PhD
role: STUDY_CHAIR
References: