Test, subjects categorised as "low risk" or "Not low risk" for Bladder Cancer

Avant Concierge Urology, Winter Garden, FL
Bladder Cancer+1 More ConditionsCxbladder - DiagnosticTest
All Sexes
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Study Summary

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

Eligible Conditions
  • Bladder Cancer
  • Blood in Urine

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: The outcome measure will be assessed by 6 months after trial completion.

Month 6
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.
Proportion of subjects (and sub-groups within test and control arms) with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
To compare the total score of the anxiety and pain level associated with cystoscopy vs Cxbladder by using Patient Result Outcome questionnaire and WIWI(was it worthy it)
To measure the change in cystoscopy procedure use count between control and test arms when Cxbladder is used in the evaluation
Upper arm
To measure the number of subjects who were incorrectly diagnosed associated with the integration of Cxbladder into the evaluation of subjects (or sub-cohorts on test and control arms) presenting with hematuria for evaluation of UC
To measure the proportion of subjects who were ruled out on the test arm when Cxbladder is used in the evaluation

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Test, subjects categorised as "low risk" or "Not low risk"
1 of 2
1 of 2

Active Control

600 Total Participants · 2 Treatment Groups

Primary Treatment: Test, subjects categorised as "low risk" or "Not low risk" · No Placebo Group · N/A

Test, subjects categorised as "low risk" or "Not low risk"
ActiveComparator Group · 1 Intervention: Cxbladder · Intervention Types: DiagnosticTest
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: the outcome measure will be assessed by 6 months after trial completion.

Who is running the clinical trial?

Pacific Edge LimitedLead Sponsor
5 Previous Clinical Trials
2,853 Total Patients Enrolled
Tony Lough, PhDStudy ChairPacific Edge Pty Ltd
1 Previous Clinical Trials
1,000 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "havent currently tryed any drugs"
How many prior treatments have patients received?

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.