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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the outcome measure will be assessed by 6 months after trial completion.
Awards & highlights

Study Summary

This trial will determine whether Cxbladder can help diagnose bladder cancer without missing any cases.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To measure the change in cystoscopy procedure use count between control and test arms when Cxbladder Triage is used in the evaluation
Secondary outcome measures
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: 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.
Group II: 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.

Find a Location

Who is running the clinical trial?

Pacific Edge LimitedLead Sponsor
6 Previous Clinical Trials
3,237 Total Patients Enrolled
Tony Lough, PhDStudy ChairPacific Edge Pty Ltd
2 Previous Clinical Trials
1,684 Total Patients Enrolled

Media Library

Cxbladder (Cancer Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT03988309 — N/A
Blood in Urine Research Study Groups: Test, subjects categorised as "low risk" or "Not low risk", Control
Blood in Urine Clinical Trial 2023: Cxbladder Highlights & Side Effects. Trial Name: NCT03988309 — N/A
Cxbladder (Cancer Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03988309 — N/A
Blood in Urine Patient Testimony for trial: Trial Name: NCT03988309 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being monitored for this research endeavor?

"Completing the trial necessitates a total of 600 patients meeting all inclusionary requirements. Potential participants can register at Carolina Urologic Research Centre in Myrtle Beach, South carolina or UT Southwestern Medical Center in Dallas, Texas and other locations."

Answered by AI

How many health centers are carrying out this clinical trial?

"The current list of 10 medical centres taking part in this study includes the Carolina Urologic Research Center, UT Southwestern Medical Centre, and Milton S Hershey Penn State Division of Urology. Additionally, there are seven other locations running trials."

Answered by AI

Are there any available openings to participate in this research?

"As of now, this trial is in search for participants. It was first posted on September 11th 2019 and the most recent modifications were made on September 20th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

havent currently tryed any drugs.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA
2019. "STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03988309.
~63 spots leftby Dec 2024
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