1000 Participants Needed

Non-Invasive Testing for Bladder Cancer

(microDRIVE Trial)

Recruiting at 3 trial locations
AM
AW
Overseen ByAlexis White, BSc (Hons)
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Pacific Edge Limited
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new, non-invasive urine test called Cxbladder can detect bladder cancer in individuals with microscopic blood in their urine. The common method for checking this is a cystoscopy, which can be painful and cause anxiety. The trial seeks to establish if Cxbladder offers a simpler and easier alternative. Suitable participants have recently visited a urology clinic for blood in their urine and can provide a urine sample from a bladder that hasn't been surgically altered. As a Phase 2 trial, this research measures how well Cxbladder performs in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in bladder cancer detection.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to better understand and categorize the risk levels for veterans with microscopic hematuria, which is blood in the urine that is not visible to the naked eye. Unlike traditional methods that might involve more invasive testing or generalized approaches, this trial focuses on precise detection and risk stratification. By improving how we identify who is at higher risk for serious conditions, this trial could lead to more personalized and effective monitoring and treatment strategies, potentially catching serious issues earlier and avoiding unnecessary procedures for low-risk individuals.

Who Is on the Research Team?

TL

Tony Lough, PhD

Principal Investigator

Pacific Edge (Australia) Pty Ltd

Are You a Good Fit for This Trial?

Inclusion Criteria

I can sign and understand the consent form.
I have blood in my urine, either visible or found under a microscope.
I can provide a urine sample naturally without any surgical alterations to my bladder.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Subjects provide a urine sample for the Cxbladder test and undergo standard of care tests including cystoscopy

Up to 10 weeks
1 visit (in-person or remote for urine sample)

Follow-up

Participants are monitored for the alignment of Cxbladder Triage-Plus results with standard diagnostic results

4 weeks

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pacific Edge Limited

Lead Sponsor

Trials
8
Recruited
4,800+