Cxbladder Triage Plus for Hematuria

(CREDIBLE Trial)

Recruiting at 15 trial locations

Overseen By Donna Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pacific Edge Limited

Must not be taking: Chemotherapy

Disqualifiers: Bladder malignancy, Upper tract UC, Gross hematuria, Reconstructed bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Cxbladder Triage Plus, a non-invasive urine test, can reduce the need for uncomfortable bladder checks (cystoscopies) in individuals with tiny amounts of blood in their urine, a potential sign of bladder cancer. Participants will be divided into two groups: one group will use the test results to decide on the necessity of a cystoscopy, while the other group will follow the usual care without access to the test results. This study targets adults diagnosed with microhematuria (small amounts of blood in urine detected only under a microscope) who can provide a urine sample. As an unphased trial, it offers a unique opportunity to contribute to research that may enhance diagnostic methods for bladder cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently receiving chemotherapy or have had chemotherapy within the last 6 weeks, you cannot participate in the trial.

What prior data suggests that the Cxbladder Triage Plus test is safe for patients with microhematuria?

Research has shown that Cxbladder Triage Plus is safe and easy for patients to use. It helps assess the risk of bladder cancer in individuals with microscopic amounts of blood in their urine. This test aids in determining whether a cystoscopy (a procedure using a small camera to examine the bladder) is necessary.

One study found that Cxbladder Triage Plus reduced the need for cystoscopies by 59% in patients with low-risk blood in their urine. This allows doctors and patients to make informed decisions without unnecessary procedures. Overall, Cxbladder Triage Plus provides a reliable and safe method for evaluating bladder cancer risk in these cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cxbladder Triage Plus because it offers a non-invasive way to help decide whether a cystoscopy, a procedure involving a camera to look inside the bladder, is necessary for patients with hematuria (blood in the urine). Unlike the standard approach that relies on direct visualization with cystoscopy, Cxbladder Triage Plus uses advanced urine testing to provide crucial information without the need for invasive procedures. This method could potentially reduce the number of unnecessary cystoscopies, making the diagnostic process safer and more comfortable for patients.

What evidence suggests that Cxbladder Triage Plus is effective for reducing cystoscopies in microhematuria patients?

Research has shown that Cxbladder Triage Plus can assess the likelihood of bladder cancer in patients with microhematuria, which refers to tiny amounts of blood in the urine visible only under a microscope. In this trial, participants in the Test Arm will receive the Cxbladder Detect+ result. The urologist study investigator will discuss this result with the participant to decide whether to proceed with cystoscopy. Studies indicate that this test can safely reduce the need for cystoscopies by 70-80%. It has a predicted sensitivity of 93.6% and specificity of 90.8%, making it both accurate and reliable in identifying potential cancer cases. Since 95-97% of patients with microhematuria do not have cancer, using this test can help most people avoid unnecessary procedures. ^{1 2 3 6 7}

Who Is on the Research Team?

Tony Lough, PhD

Principal Investigator

Pacific Edge Limited

Are You a Good Fit for This Trial?

Adults aged 18 to 88 with invisible blood in their urine, confirmed by a lab test within the last 90 days. They must be able to provide a urine sample and understand English or Spanish (with an interpreter if needed). Participants should be willing to follow study procedures and give informed consent.

Inclusion Criteria

I am willing and able to follow the study's requirements.

I can understand and sign the consent form.

I can provide a urine sample naturally without any surgical changes to my bladder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants provide a urine sample for the Cxbladder Triage Plus test and are randomly assigned to test or control groups

1 week

1 visit (in-person)

Decision Phase

Urologists and patients decide on cystoscopy based on Triage Plus results or standard care

Up to 3 months

1-2 visits (in-person)

Follow-up

Participants are monitored for persistent hematuria and other outcomes

3-6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cxbladder Triage Plus

Trial Overview The trial is testing whether using 'Cxbladder Triage Plus,' a genetic urine test for bladder cancer, can reduce the number of cystoscopies needed. Patients are randomly assigned to either get this new test result before deciding on cystoscopy or follow standard care without the test result.

How Is the Trial Designed?

Group I: Test Arm Experimental Treatment 1 Intervention

The 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.

Group II: Control arm Active Control 1 Intervention

Neither 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.

Who Is Running the Clinical Trial?

Pacific Edge Limited

Lead Sponsor

Trials

8

Recruited

4,800+

Citations

1. cxbladder.com cxbladder.com/us/clinicians/hematuria-evaluation/

Cxbladder for hematuria evaluation 95-97% of patients presenting with microhematuria do not have urothelial cancer and 70-80% of cystoscopies can be safely avoided using a non- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293762/

Analytical Validation of the Cxbladder® Triage Plus Assay for ... Triage Plus was evaluated for predicted performance, analytical criteria (linearity, sensitivity, specificity, accuracy, and precision), ...

3. cxbladder.com cxbladder.com/us/news/2025/cxbladders-clinical-utility-in-focus-at-aua-2025/

Cxbladder's Clinical Utility in Focus at AUA 2025 As a single test for hematuria evaluation, Triage Plus is optimized for the risk stratification of patients presenting with microhematuria.

4. cxbladder.com cxbladder.com/assets/News/Cxbladder-Bulletin-Apr-2025-APAC.pdf

Cxbladder Bulletin Apr 2025 - APAC The design of the study prospectively managed hematuria patients according to the new. Triage-based standard of care and then retrospectively ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40722489/

Analytical Validation of the Cxbladder® Triage Plus Assay ... Compared with cystoscopy (standard of care), Triage Plus had a predicted sensitivity of 93.6%, specificity of 90.8%, positive predictive value ( ...

6. cxbladder.com cxbladder.com/us/news/2025/clinical-value-of-cxbladder-to-feature-at-uaa-2025/

Clinical Value of Cxbladder to Feature at UAA 2025 These findings indicate that Triage Plus may be safely used to rule out or detect [urothelial cancer] in patients with hematuria.” The DRIVE is ...

7. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003991

The Safe Testing of Risk for Asymptomatic Microhematuria ... In this prospective randomized controlled trial, use of CxbT in patients with LR hematuria resulted in 59% reduction of cystoscopy use.