Cxbladder Triage Plus for Hematuria

(CREDIBLE Trial)

Recruiting at 7 trial locations

Overseen By Tony Lough, PhD

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

Trial Summary

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 data supports the effectiveness of the treatment Cxbladder Triage Plus for hematuria?

Research shows that using Cxbladder Triage, a urine test, can help identify patients with a low risk of bladder cancer, potentially reducing the need for invasive procedures like cystoscopy (a procedure to look inside the bladder). This suggests that Cxbladder Triage Plus could be effective in managing hematuria by minimizing unnecessary tests. ^{1 2 3 4 5}

How does the Cxbladder Triage Plus treatment for hematuria differ from other treatments?

Cxbladder Triage Plus is unique because it uses a urine-based genomic test to help decide if a patient with hematuria (blood in urine) needs a cystoscopy (a procedure to look inside the bladder), potentially reducing the need for invasive procedures. ^{3 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Tony Lough, PhD

Principal Investigator

Pacific Edge Limited

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Assessment of a clinical pathway for investigation of haematuria that reduces the need for cystoscopy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The Diagnostic Performance of Cxbladder Resolve, Alone and in Combination with Other Cxbladder Tests, in the Identification and Priority Evaluation of Patients at Risk for Urothelial Carcinoma. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Hemorrhagic Cystitis Requiring Bladder Irrigation is Associated with Poor Mortality in Hospitalized Stem Cell Transplant Patients. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Clinical utility of a non-invasive urine test for risk assessing patients with no obvious benign cause of hematuria: a physician-patient real world data analysis. [2018]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Inclusion of a molecular marker of bladder cancer in a clinical pathway for investigation of haematuria may reduce the need for cystoscopy. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A Urine Based Genomic Assay to Triage Patients with Hematuria for Cystoscopy. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of hematuria. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Simple method for the management of hematuria caused by radiation or cytoxan. [2019]

9. China pubmed.ncbi.nlm.nih.gov

[Hemorrhagic cystitis in the course of hematopoietic stem cell transplantation]. [2014]