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)

Overview

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.

Interventions

• Diagnostic test Cxbladder 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.

Primary outcome measures

• Cystoscopy rate [Time frame: 3 months from the decision to perform or not perform cystoscopy.]

Secondary outcome measures (6)

• Detection of urothelial carcinoma (UC) [Time frame: 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. [Time frame: Up to 180 days after the investigational decision (whether to proceed with cystoscopy) was made.]
• Persistent hematuria. [Time frame: At urinalysis 90-180 days (of the decision to proceed with surveillance)]
• Missed UCs [Time frame: 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.]]
• Imaging Rates [Time frame: 3-months prior to 6-months post enrollment]
• Rate of imaging procedures [Time frame: 3 months from the decision to perform or not perform cystoscopy.]

Eligibility criteria

Inclusion criteria

• Patient is referred for assessment of recent hematuria, defined as either:

• Microscopic hematuria (≥3 RBC/HPF or equivalent) on urine microscopy obtained within 180 days prior to enrollment, OR
• Hematuria detected by dipstick analysis (≥2+ blood or equivalent) at referral and confirmed on the same calendar day and prior to enrollment, with urine microscopy collected on the same day as 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 criteria

• Prior history of bladder malignancy.
• Prior history of upper tract UC or prostatic urethral UC.
• History of gross hematuria requiring instrumentation or hospitalization within the last 12 months
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 20 centers

• Urology Centers of Alabama — Homewood
• Urology Associates of Mobile — Mobile
• Urology Associates of Central California — Fresno
• Urology Group of Southern California — Los Angeles
• Comprehensive Urology — Los Angeles
• Advanced Urology Institute - Daytona Beach — Daytona Beach
• Urologic Specialists of Northwest Indiana — Merrillville
• Southern Urology — Lafayette
• … and 12 more centers

Identifiers

NCT: NCT06394869 · CXB/2024/CREDIBLE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗