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: 18th Jan, 2022 

 

Ongoing Study Program Enrolled Sites & Locations Progress & Targets*
STRATA
Safe Testing of Risk for AsymptomaTic MicrohematuriA
11/11 USA and Canada
  • Enrolment total is 430, including 106 'low risk' subjects that are the focus of the study
  • Target ~600 subjects, including 120 low risk subjects randomized to test arm
  • Last patient in Q2 2023
  • Follow up until Q2 2024
DRIVE

Detection and RIsk Stratification in VEterans Presenting with Hematuria

10/11 (VA) USA
  • Enrolment total is 513
  • Target(Q2 2025) ~600 patients
  • Last patient in: Q2 2023
  • Follow up: until Q2 2025
AUSSIE
Australian Urologic Risk Stratification of PatientS wIth HEmaturia
1/1 Australia
  • Enrolment due to start in March 2023
DEDUCT

DEtection of Disease in the Upper TraCT

1/3
  • One site is open for this pilot study and the first patient is expected by Dec 2022
LOBSTER

LOngitudinal Bladder Cancer Study for Tumor REcurRence

2/10
  • Two sites are open and another 8 are at pre-activation. Enrolment is now 27 patients
  • Each site will enrol 100 patients within 12 months and follow up for another 12 months
MONSTER

MONitoring Study of Post-Treatment Effectiveness for Residual Disease

0/1 New Zealand 

  • Finalizing protocol documentation and commenced engagement with ethics committee
  • Target (Q1 2023) first patient

* 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

Our clinical studies are principally aimed at delivering two types of evidence: clinical validity (CV) evidence (evidence that Cxbladder accurately identifies a patient’s clinical status in an independent patient cohort) and clinical utility (CU) evidence (evidence that Cxbladder is clinically useful for physicians for a defined population and indication). We are also undertaking studies to deliver analytical validity (AV) evidence (evidence that a test is repeatable in laboratory conditions).

 

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

  • Establish CU for Cxbladder Triage in microhematuria populations to identify patients at low risk of bladder cancer that can safely avoid cystoscopy
  • Retrospective analysis with Cxbladder Detect+ to show equivalent or greater CU in microhematuria populations with the improved performance characteristics
  • CU evidence supports AUA/NCCN guidelines inclusion using Cxbladder Triage and/or Cxbladder Detect+ to risk stratify microhematuria populations

 

DRIVE: Prospective recruitment of patients to a single- arm observational study to demonstrate the CV & CU of Cxbladder tests in risk stratifying Veterans presenting with hematuria

  • CV evidence for Triage in microhematuria & gross hematuria patients supplementing NZ Studies
  • Demonstrate CV of Cxbladder Detect+ within a Veterans cohort
  • Retrospective analysis with Cxbladder Detect+ to demonstrate CV evidence supporting AUA/NCCN Guidelines inclusion in microhematuria & gross hematuria patients
  • Contribute data to meta-analysis to establish CV for Detect+ in microhematuria patients

 

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

  • Demonstrate CV of Cxbladder Detect+ with an Australian cohort
  • Demonstrate accurate risk stratification of hematuria patients to intensify or de-intensify evaluation
  • Contribute data to meta-analysis to establish CV for Detect+ in microhematuria patients

 

DEDUCT: Prospective recruitment of patients to a single-arm observational study to validate performance of Cxbladder Detect+ for the detection of urothelial carcinoma (UC) in the upper tract (UTUC)

  • CV of Cxbladder Detect+ for the detection of UTUC
  • To safely risk stratify patients suspected to have UTUC and avoid unnecessary ureteroscopy and radiation exposure through imaging
  • Targeting inclusion of Cxbladder utility for UTUC in AUA/NCCN guidelines

 

LOBSTER: Prospective recruitment of patients to a single-arm observational study to evaluate the clinical validity of CxbM

  • To safely risk stratify patients under surveillance for recurrence of UC
  • To demonstrate that it is safe to alternate CxbM 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

 

MONSTER: Single-arm, observational study to validate the performance characteristics of Cxbladder against white light cystoscopy during surveillance of UC

  • Christchurch study to measure residual disease
  • To safely risk stratify patients for residual disease prior to the 6-week re-resection for high grade patients or the 3-month flexible cystoscopy check for all patients

Investigator Initiated Trials (Selected Studies Only)

Coming soon.