What side effects are associated with this type of intervention?

Common treatments for hematuria related to urothelial carcinoma include noninvasive urine tests like cytology, NMP22 BladderChek, and Cxbladder. These tests are generally safe and noninvasive, with minimal side effects primarily related to the collection of urine samples. Invasive treatments, such as cystoscopy or biopsy, may cause discomfort, bleeding, or infection. For more advanced cases, treatments like intravesical chemotherapy (e.g., mitomycin C, gemcitabine) can cause local side effects such as bladder irritation, pain, and urinary frequency, as well as systemic effects like nausea and fatigue.

What prior FDA approvals exist?

The FDA has approved several noninvasive urine tests for the detection of urothelial carcinoma, which can present as blood in the urine (hematuria). One such test is the Cxbladder Monitor, which detects genetic markers associated with urothelial carcinoma in urine samples. This test has shown high sensitivity and negative predictive value compared to traditional methods like cytology and NMP22 tests. Other related FDA-approved tests include the UroVysion fluorescence in situ hybridization (FISH) test, which also detects genetic abnormalities in urine samples to diagnose urothelial carcinoma.

What other types of research exist?

Promising alternatives to Cxbladder for detecting urothelial carcinoma in patients with blood in urine include UroVysion® FISH and NMP22®. UroVysion® FISH uses fluorescence in situ hybridization to detect chromosomal abnormalities, while NMP22® measures nuclear matrix protein levels in urine. Both have been used for non-invasive detection of bladder cancer and have shown efficacy in clinical settings.

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Cancer Diagnostic Test

Cxbladder Testing for Bladder Cancer

N/A

Waitlist Available

Research Sponsored by Pacific Edge Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is undergoing investigation of recent confirmed hematuria, as defined by the AUA/SUFU Guideline (Barocas DA, Boorjian SA, Alvarez RD et al. Microhematuria: AUA/SUFU guideline, J Urol 2020; 204:778) (by either flexible or rigid cystoscopy/TURBT), including hematuria subjects referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.

Able to provide a voided urine sample of the required minimum volume

Must not have

Prior history of bladder malignancy or pelvic radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the outcome measure will be assessed by 6 months after trial completion.

Awards & highlights

Summary

This trial is testing a urine test called Cxbladder to help detect bladder cancer in patients who have blood in their urine. The goal is to see if this test can find cancer without missing any cases. Cxbladder is a non-invasive urine test that has shown usefulness in ruling out bladder cancer in patients who have blood in their urine without other symptoms.

Who is the study for?

This trial is for adults over 18 who can consent and follow study rules. They must be investigating blood in their urine to check for bladder cancer, able to provide a urine sample, and not have had any recent urinary procedures or a history of certain cancers or pelvic radiotherapy.

What is being tested?

The STRATA trial is testing the Cxbladder test's effectiveness in evaluating patients with hematuria (blood in urine) for urothelial carcinoma (a type of bladder cancer), without missing any cases of this cancer.

What are the potential side effects?

Since Cxbladder is a non-invasive urine test designed to detect bladder cancer, it does not have side effects like drugs or surgical interventions. The main concern would be the accuracy and reliability of detecting urothelial carcinoma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am being checked for bladder cancer because of recent blood in my urine.

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I can provide the needed amount of urine for a sample.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bladder cancer or radiation treatment in the pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the outcome measure will be assessed by 6 months after trial completion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the outcome measure will be assessed by 6 months after trial completion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the outcome measure will be assessed by 6 months after trial completion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To measure the change in cystoscopy procedure use count between control and test arms when Cxbladder Triage is used in the evaluation

Secondary study objectives

Quantify performance characteristics of Cxbladder signatures including for the detection of high grade/stage UC.

To clinically validate the performance characteristics and test negative rate of the Cxbladder Detect+ test.

Upper arm

+1 more

Trial Design

2Treatment groups

Active Control

Group I: ControlActive Control1 Intervention

Subjects on the control arm will be on standard of care. Trial nomogram clinical risk factor categorization for control arm subjects will not be provided to the physician (but appropriate information will be collected on the CRF to enable sub-group analysis) No Cxbladder test results will be provided for control arm subjects. Note that Cxbladder test results will be available for eventual analysis for these subjects.

Group II: Test, subjects categorised as "low risk" or "Not low risk"Active Control1 Intervention

A clinical risk factor nomogram risk classification will be used in this study. The nomogram categorizes subjects as either "low risk" or "not low risk" categories. "Low risk" subjects satisfy all conditions and "not low risk" satisfies at least one of the conditions.The Cxbladder Triage test result will be provided to physicians for all "low risk" subjects on the test arm. If a "low risk" subject has a Cxbladder Triage negative test result then the indication is to rule out the subject without further assessment. The decision to rule-out or further evaluate is solely that of the physician and subject. If the "low risk" subjects are not Cxbladder Triage negative then a Cxbladder Detect test result will also be provided. The indication is further evaluation as per standard of care. Subjects categorised as "not low risk" will be evaluated as per standard of care. Note that Cxbladder test results will be available for eventual analysis for these subjects.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood in urine (hematuria) include addressing underlying causes such as infections, stones, or tumors. For bladder cancer, treatments often involve surgical interventions, chemotherapy, and immunotherapy. The Cxbladder test, which detects genetic markers in urine, helps in early diagnosis and monitoring of urothelial carcinoma. This matters for hematuria patients as early detection of bladder cancer can significantly improve prognosis and guide appropriate treatment, reducing the risk of advanced disease and associated complications.

Liquid Biopsy Biomarkers in Urine: A Route towards Molecular Diagnosis and Personalized Medicine of Bladder Cancer.Liquid Biopsy Analysis of FGFR3 and PIK3CA Hotspot Mutations for Disease Surveillance in Bladder Cancer.