Cxbladder Testing for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Pacific Edge Limited

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Tony Lough, PhD

Principal Investigator

Pacific Edge Pty Ltd

Eligibility Criteria

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.

Inclusion Criteria

Able to give written consent

Able and willing to comply with study requirements

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

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Exclusion Criteria

I have not had any bladder or urinary procedures in the last 14 days.

I have had prostate or kidney cancer in the last 5 years.

Known current pregnancy

See 1 more

Treatment Details

Interventions

Cxbladder (Cancer Diagnostic Test)

Trial OverviewThe 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.

Participant Groups

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.