Clinical Trials

Clinical Trials

Clinical evidence fundamentally underpins commercial success in healthcare and consequently is one of the key pillars of our investment program. High-quality clinical evidence is needed by clinicians to make the decision to adopt Cxbladder in clinical practice and by healthcare payors to make decisions to cover and reimburse a Cxbladder test. The guidelines committees of professional medical societies, including the American Urological Association (AUA), the National Comprehensive Cancer Network (NCCN) and the European Association of Urology (EAU), also rely on this evidence to support embedding Cxbladder as a standard of care.

Status of Studies Within Our Clinical Trials Program

Last updated: 22nd Jan, 2025 

 

Ongoing Study Program Goal Population and Use Status
STRATA
Safe Testing of Risk for AsymptomaTic MicrohematuriA

  • CU for Triage

  • CV/CU for Triage Plus (retrospective)

  • Microhematuria (MH)

  • Risk stratification

  • Recruitment closed with 555 patients including 223 low risk patients (test and control) with interim analysis results published in Journal of Urology

  • Monitoring for final analysis completed mid-Aug, some re-work needed. Database lock March 2025 and final Clinical Study Report (CSR) expected Sep 2025
DRIVE

Detection and RIsk Stratification in VEterans Presenting with Hematuria

  • CV for Triage Plus for a Veterans’ cohort

  • Data for MH pooled analysis

  • MH and gross hematuria (GH)

  • Risk stratification

  • Enrolment closed with 710 patients enrolled including 48 tumor confirmed patients (target was 45) from across 10 US VA sites

  • Database lock completed and publication submission expected by March 2025

microDRIVE

Detection and RIsk Stratification in VEterans Presenting with MicroHematuria

  • CV of Triage Plus

  • Data for MH pooled analysis

  • MH

  • Detection

  • Currently a decentralised study across all VAMCs coordinated through a single US VA Medical Center. Protocol amendment provides for addition of 4 more sites to increase enrolment

  • 447 patients have consented for the study with 224 samples received to date

  • The target is 1000 patients with 35 tumor confirmed patients

  • Last patient in is now projected to be Q3-2025
AUSSIE
Australian Urologic Risk Stratification of PatientS wIth HEmaturia

  • CV of Triage Plus (Australian cohort)

  • Data for pooled analysis

  • MH and GH

  • Risk stratification

  • The target is 35 UC confirmed patients including a minimum of 10 MH patients

  • Currently 456 subjects enrolled with 29 UC confirmed including 5 MH patients

  • Last patient in projected to be Q2-2025
Pooled Analysis

 

  • CV of Triage Plus

  • MH and GH

  • Risk stratification

  • MH (and separately GH patient data where available) from DRIVE, AUSSIE and microDRIVE will be pooled and performance determined

  • Paper submission is one quarter after publication of DRIVE, microDRIVE and AUSSIE
LOBSTER

LOngitudinal Bladder Cancer Study for Tumor Recurrence

  • CV of Monitor/ Monitor Plus

  • Surveillance

  • Risk stratification

  • Enrolment will be complete when 75 UC recurrences are observed across 10–15 sites

  • Enrolment is 413 subjects providing 810 samples with 48 UC recurrences observed to date and expected completion is Q3-2026

CREDIBLE

Cystoscopic REDuction In BLadder Evaluations for microhematuria

  • CU of Triage Plus

  • MH

  • Risk stratification

  • Protocol IRB approved for 14 and contracts finalized for 6 of expected 15 sites

  • Interim analysis will occur at 600 to determine if incidence is <5% and if so will continue until 1000 are enrolled

  • Enrolment due to commence February 2025

* Dates are calendar years, not financial years
** Pacific Edge's IRB-approved clinical trials are listed at clinicaltrials.gov

The Strategic Rationale For Each Study

Cxbladder tests are designed to risk stratify patients presenting with hematuria or undergoing surveillance for recurrence of bladder cancer. A negative test result means that a patient is low risk of urothelial carcinoma (bladder cancer) and investigative cystoscopy need not be undertaken or can be rescheduled to a later date without any negative impact on patient care.

 

STRATA: Demonstrate the clinical utility (CU) of Cxbladder Triage using a prospective, two-arm randomized design to risk-stratify patients and rule out investigative cystoscopy.

  • Establish CU for Cxbladder Triage in a microhematuria population to identify patients at low risk of bladder cancer that can safely not undertake investigative cystoscopy.
  • Retrospective analysis with Cxbladder Triage Plus to show concordance of results for the second-generation test in microhematuria populations with the improved performance characteristics.
  • CU evidence supports AUA/NCCN guidelines inclusion using Cxbladder Triage.

 

DRIVE: Prospective recruitment of patients to a single-arm observational study to demonstrate the CV of Cxbladder Triage Plus in a population of Veterans presenting with hematuria.

  • Demonstrate CV of Cxbladder Triage Plus within a Veterans population supporting AUA/NCCN Guidelines inclusion in microhematuria & gross hematuria patients.
  • Contribute data to a pooled-analysis to establish CV for Triage Plus for patients presenting with microhematuria.
  • CV evidence for Cxbladder Triage in microhematuria & gross hematuria patients supplementing NZ studies.

 

microDRIVE: Prospective recruitment of patients to a single-arm observational study providing CV for patients presenting with microhematuria.

  • Demonstrate the clinical validity of Cxbladder Triage Plus  in detecting urothelial cancer in patients presenting with microhematuria.
  • Contribute data to a pooled-analysis to establish CV for patients presenting with microhematuria.

 

AUSSIE: Prospective recruitment of patients to a single-arm observational study providing CV in an Australian healthcare setting for patients presenting with hematuria.

  • Demonstrate CV of Cxbladder Triage Plus.
  • Contribute data to meta-analysis to establish CV for Triage Plus in microhematuria patients.

 

Microhematuria Pooled Analysis: Pooled-analysis of Cxbladder Triage Plus performance from multiple studies involving prospectively recruited patients from single-arm observational studies including eligible microhematuria patients.

  • CV of Cxbladder Triage Plus with microhematuria patients.
  • Combines data from DRIVE, AUSSIE, and microDRIVE.
  • CV evidence supports AUA/NCCN guidelines inclusion using Cxbladder Triage Plus to risk stratify patients presenting with microhematuria.

 

LOBSTER: Prospective recruitment of patients to a single-arm observational study to evaluate the clinical validity of Cxbladder Monitor/Monitor Plus.

  • To safely risk stratify patients under surveillance for recurrence of urothelial cancer (UC).
  • To demonstrate that it is safe to alternate Cxbladder Monitor with cystoscopy for intermediate and high-risk patients under surveillance for recurrence of UC.
  • Targeting AUA/NCCN guidelines inclusion for biomarkers as an alternative to cystoscopy in a surveillance setting.

 

CREDIBLE: Demonstrate the clinical utility (CU) of Triage Plus using a randomized controlled study design prospectively enrolling microhematuria patients scheduled for evaluation of said hematuria

  • Will compare cystoscopy use for patients in the control arm risk stratified by AUA Standard of Care guidelines into high, intermediate and low risk with patients in the test arm risk stratified by Cxbladder Detect and managed as AUA high risk (Triage Plus positive) and AUA low risk (Triage Plus negative)

 

  • Analytical Validity (AV): Develop a test that is repeatable in the lab for a given indication and population.
  • Clinical Validity (CV): Make sure the test works in the same way on an independent eligible population for the given indication.
  • Clinical Utility (CU): Put the test in the hands of a physician to establish that it can usefully change patient management within the context of care for the defined population and indication.