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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Arm | Experimental | The site will receive the Cxbladder Triage+ 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 Intervention | Neither the site nor the patient will receive the Cxbladder Triage+ result. The decision whether or not to proceed with cystoscopy will be made following standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cxbladder Triage Plus | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cystoscopy rate | Difference in the proportion of cystoscopies performed in each arm. | 3 months from the decision to perform or not perform cystoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of urothelial carcinoma (UC) | Difference in the proportion of UCs found in each arm. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physician rationale | Physician-reported reasons for not following the study recommended pathway based on the Detect+ result. | After reviewing the Detect+ result and giving their recommendation, before cystoscopy (if applicable). Expected once and within 90 days of sampling |
| Imaging Utilisation |
Inclusion Criteria:
Patient is referred for assessment of recent hematuria, defined as either:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donna Smith | Contact | +64212436696 | Donna.Smith@pacificedgedx.com | |
| Tony Lough, PhD | Contact | +64 (0)21 0223 8591 | tony.lough@pelnz.com |
| Name | Affiliation | Role |
|---|---|---|
| Tony Lough, PhD | Pacific Edge Limited | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama | Recruiting | Homewood | Alabama | 35209 | United States |
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Number of false positive, true positive, false negative and true negative test results when comparing the Triage Plus result to the results of histopathologically confirmed cystoscopy. |
| Up to 180 days after the investigational decision (whether to proceed with cystoscopy) was made. |
| Persistent hematuria. | Rate of persistent hematuria in patients choosing surveillance. | At urinalysis 90-180 days (of the decision to proceed with surveillance) |
| Missed UCs | Number of UCs in both arms identified during the surveillance phase. | 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 | Change in imaging rates between arms | 3-months prior to 6-months post enrollment |
| Rate of imaging procedures | Sub-analyses on AUA risk categories for primary and secondary objectives | 3 months from the decision to perform or not perform cystoscopy. |
Change in number and modality of imaging procedures |
| From 3 months prior to 6 months post enrollment. |
| Dipstick Subgroup | Proportion of subjects enrolled via dipstick-positive hematuria who meet guideline-defined microhematuria based on urine microscopy. | At enrolment |
| Urology Associates of Mobile | Recruiting | Mobile | Alabama | 36608 | United States |
|
| Urology Associates of Central California | Recruiting | Fresno | California | 93720 | United States |
|
| Urology Group of Southern California | Recruiting | Los Angeles | California | 90017-4007 | United States |
|
| Comprehensive Urology | Recruiting | Los Angeles | California | 90048 | United States |
|
| Advanced Urology Institute - Daytona Beach | Recruiting | Daytona Beach | Florida | 32114 | United States |
|
| Urologic Specialists of Northwest Indiana | Recruiting | Merrillville | Indiana | 46410 | United States |
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| Southern Urology | Terminated | Lafayette | Louisiana | 70508 | United States |
| Chesapeake Urology Research Associates | Recruiting | Hanover | Maryland | 21076 | United States |
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| Summit Health | Recruiting | Voorhees Township | New Jersey | 08043 | United States |
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| Albany MED Health System | Recruiting | Albany | New York | 12208 | United States |
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| Integrated Medical Professionals | Recruiting | New York | New York | 11042 | United States |
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| Premier Medical Group of the Hudson Valley, P. C. | Recruiting | Poughkeepsie | New York | 12601 | United States |
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| Dayton Physicians Network | Recruiting | Dayton | Ohio | 45409 | United States |
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| Penn State Medical Center, Urology Research | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Urology Associates, P. C. | Terminated | Nashville | Tennessee | 37209 | United States |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Austin Urology Institute | Not yet recruiting | Austin | Texas | 78758 | United States |
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| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| University of Wisconsin-Madison | Recruiting | Madison | Wisconsin | 53792 | United States |
|
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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