Hematuria - Cause Not KnownCREDIBLENCT06394869
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.
A study testing Cxbladder Triage Plus in people with Hematuria - Cause Not Known, run by Pacific Edge Limited at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hematuria - Cause Not Known
- What is being tested?
- Cxbladder Triage Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 20 sitesUnited States
- Study dates
- 29 Apr 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 18 recruiting
- Recruiting
Albany MED Health System
Albany, New York, 12208
Adrien N Bernstein, MD, 518-262-8579, AMCurologyresearch@amc.edu
Laura Davey, CCRC, 518-262-8579, AMCurologyresearch@amc.edu
- Not yet recruiting
Austin Urology Institute
Austin, Texas, 78758
Amanda Mason, 512-694-8888 ext. 15, amason@folioclinicalresearch.com
Koushik Shaw, MD
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Perla Lopez, 2146459195, Perla.Lopez@UTSouthwestern.edu
Maricruz Ibarra, 2146458787, Maricruz.Ibarra@UTSouthwestern.edu
- Recruiting
Dayton Physicians Network
Dayton, Ohio, 45409
Sandy Evers, (937) 771-2287, severs@daytonphysicians.com
David Key, MD
- Recruiting
Advanced Urology Institute - Daytona Beach
Daytona Beach, Florida, 32114
Samuel Lawindy, MD, 3862398500, samuel.lawindy@auihealth.com
Samuel Lawindy, MD
- Recruiting
Urology Associates of Central California
Fresno, California, 93720
Kristin Santeufemia, 559 321 2924, "Kristin Santeufemia" <ksanteufemia@urologyassociates.net>
William Schiff, MD
- Recruiting
Chesapeake Urology Research Associates
Hanover, Maryland, 21076
Rian J Dickstein, MD, 443-231-1313, rdickstein@chesuro.com
Rian J Dickstein, MD
- Recruiting
Penn State Medical Center, Urology Research
Hershey, Pennsylvania, 17033
Sneha Patel, 717-531-0003 ext. 283173, urologyresearch@pennstatehealth.psu.edu
Jay D Raman, MD
- Recruiting
Urology Centers of Alabama
Homewood, Alabama, 35209
Meredith A Sharpton, PA-C, 205-445-0129, msharpton@urologyal.com
Rita Aderholt, CCRC, 205-445-0124, raderholt@urologyal.com
- Terminated
Southern Urology
Lafayette, Louisiana, 70508
- Recruiting
Urology Group of Southern California
Los Angeles, California, 90017-4007
Shahzada Khurram, (424) 337-1411, skhurram@folioclinicalresearch.com
John Kowalczyk, DO
- Recruiting
Comprehensive Urology
Los Angeles, California, 90048
Kiarash Michel, MD, +1 310-278-8330, kiamichel@gmail.com
Shazada Khurram, skhurram@folioclinicalresearch.com
- Recruiting
University of Wisconsin-Madison
Madison, Wisconsin, 53792
Rebecca Marrah, 608-262-3241, marrah@urology.wisc.edu
Abigail Wiedmer, 608-265-9172, wiedmer@urology.wisc.edu
- Recruiting
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, 46410
Shawna Clemons, 2107698641, sclemons@urologis-specialists.com
Michelle Ramos, 2192591291, mramos@urologic-specialists.com
- Recruiting
Urology Associates of Mobile
Mobile, Alabama, 36608
Pamela R Manley, 251-234-5933, pmanley@uampa.com
Letoya Craig, 251-234-5933, lcraig@uampa.com
- Terminated
Urology Associates, P. C.
Nashville, Tennessee, 37209
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Kristen R Scarpato, MD, 615.343.2120, Kristen.r.scarpato@vumc.com
Kristen R Scarpato, MD
- Recruiting
Integrated Medical Professionals
New York, New York, 11042
Michael Yang, 9174093932, myang@imppllc.com
Jed Kaminetsky, MD
- Recruiting
Premier Medical Group of the Hudson Valley, P. C.
Poughkeepsie, New York, 12601
Lisa Cotton, RN, BSN, CCRC, 845-437-3082, lgrey@premiermedicalhv.com
Jennifer Rose, LPN, CRC, 845-437-5082, jrose@premiermedicalhv.com
- Recruiting
Summit Health
Voorhees Township, New Jersey, 08043
Alice Drew, 856-900-6753, adrew@summithealth.com
Kelley Mauro, 856-673-1613, kmauro@summithealth.com
About this study
Official title: Cystoscopic REDuction In BLadder Evaluations for Microhematuria - A Prospective Randomized, Controlled, Clinical Utility Study for Evaluation of Microhematuria (The CREDIBLE Study)
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.
Read more
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.
- Conditions
- Hematuria - Cause Not Known
- Being tested
- Cxbladder Triage Plus
- Keywords
- microscopic hematuria, microhematuria, urothelial carcinoma, bladder cancer
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cxbladder Triage PlusDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cxbladder Triage Plus |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystoscopy rate
Difference in the proportion of cystoscopies performed in each arm.
Measured: 3 months from the decision to perform or not perform cystoscopy.
Secondary outcomes (6)
Detection of urothelial carcinoma (UC)
Difference in the proportion of UCs found in each arm.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3-months prior to 6-months post enrollment
Rate of imaging procedures
Sub-analyses on AUA risk categories for primary and secondary objectives
Measured: 3 months from the decision to perform or not perform cystoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start29 Apr 2025
- Primary completionOct 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematuria - Cause Not KnownStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific Edge Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Lough, PhD, Study chair, Pacific Edge Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394869
- Sponsor's protocol ID
- CXB/2024/CREDIBLE
- Acronym
- CREDIBLE
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystoscopic REDuction In BLadder Evaluations for Microhematuria - A Prospective Randomized, Controlled, Clinical Utility Study for Evaluation of Microhematuria (The CREDIBLE Study)
- ClinicalTrials.gov ID
- NCT06394869
- Acronym / sponsor ID
- CREDIBLE / CXB/2024/CREDIBLE
- Conditions
- Hematuria - Cause Not Known
- Keywords
- microscopic hematuria, microhematuria, urothelial carcinoma, bladder cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pacific Edge LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Diagnostic Test: Cxbladder Triage PlusThe 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. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cxbladder Triage PlusCxbladder 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. | Diagnostic test | Test Arm |
Primary outcome
Cystoscopy rate
Time frame: 3 months from the decision to perform or not perform cystoscopy.
Difference in the proportion of cystoscopies performed in each arm.
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tony Lough, PhD study chair
Pacific Edge Limited
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cxbladder Triage Plus in people with Hematuria - Cause Not Known, run by Pacific Edge Limited at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna Smith (+64212436696, Donna.Smith@pacificedgedx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystoscopy rate (time frame: 3 months from the decision to perform or not perform cystoscopy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.