Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria (microDRIVE)

Validation of Cxbladder Detect-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria (microDRIVE)

It is of current debate whether the use of invasive (referring to a process that requires insertion into the body) standard of care procedures such as a cystoscopy which is a procedure to look inside the bladder using a thin camera called a cystoscope, is appropriate for use in patients with microscopic hematuria or blood in urine invisible to the naked eye. This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low in this population group, approximately 3%. Invasive procedures such as a cystoscopy comes with anxiety and pain, in addition to other potential side effects. This has resulted in low admittance in urology clinics for cystoscopy with hematuria (blood in urine) patients. Therefore, there is a need for a more simple, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. There is a potential role Cxbladder, a non-invasive, urine based test, can fill this role.

Study Overview

• Status: Recruiting
• Conditions: Urothelial Carcinoma
• Intervention / Treatment: Diagnostic test: Cxbladder urine test

Detailed Description

This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria from Veterans Affairs Medical Centers. This study will be conducted with subjects with a previous history of microscopic hematuria (three or more red blood cells per high powered field in one urinalysis) undergoing clinical assessment including cystoscopy. Consented, eligible subjects will undergo all standard of care tests as clinically indicated. In addition, one additional urine sample, using remote (at-home) sampling, will be collected to validate the performance characteristics for the Cxbladder Detect-plus test. The urine sample collected from each subject will be a voided urine sample at one time point prior to the scheduled cystoscopy.

The primary aim of this study is to validate the use of Cxbladder Detect-plus as an effective diagnostic tool to:

1. Enable patients with microscopic hematuria who have a low probability of having disease (urothelial carcinoma) to be ruled out from further investigation. This will avoid expensive, invasive work-up, without compromising detection of disease.
2. Allow physicians to identify subjects at high risk of disease (urothelial carcinoma)
3. Replace less sensitive urine-based tests (such as urine cytology or other urine genomic tests currently available)
4. Adjudicate atypical cytology or equivocal cystoscopy results

Cxbladder results will not be reported to the subjects or the physicians. Each subject will be required to fill in the date of sample collection in the test-request form and Cxbladder tubes. The site will fill in case-report forms in a professional manner in accordance with good clinical practice (GCP).

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ash Maharjan, PhD; Phone Number: +64 27 318 0613; Email: ash.maharjan@pelnz.com
• Study Contact Backup: Name: Alexis White, BSc (Hons); Phone Number: +64 21 959 001; Email: alexis.white@pelnz.com

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Durham VA Health Care System
      • Contact: Ally Shelley; Phone Number: 919-286-0411; Email: Mary.shelley@va.gov
      • Contact: Meredith Muller; Phone Number: +1 931 309 2792; Email: meredith.muller@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria from Veterans Affairs Medical Centers. This study will be conducted on subjects with microscopic hematuria (three or more RBC/HPF; no visible blood in urine) undergoing clinical assessment. Consented, eligible subjects will undergo all standard tests as clinically indicated with the addition of a urine sample for Cxbladder testing before standard of care assessments are undertaken.

Description

Inclusion Criteria:

• Subject is referred to urology and scheduled for cystoscopy for the evaluation of microscopic hematuria after recent confirmed microscopic hematuria presentation by urine microscopy of three or more RBC/HPF
• Able to provide a voided urine sample
• Able to give informed, written consent
• Able and willing to comply with study requirements (complete at-home urine sampling, fill in test request forms (TRFs) / tube labels and ship urine back to the central laboratory using a prepaid courier service)
• Aged 18 years or older

Exclusion Criteria:

• Prior history of bladder malignancy
• Visible blood in the urine within the last six months (reported in subject's records and / or during subject's interview)
• Cystoscopy within the last six months
• Reported Cxbladder results within the last six months

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The alignment of Cxbladder Detect-plus results with the standard of care diagnostic result for the presence or absence of UC, to validate Cxbladder Detect-plus performance in subjects with microscopic hematuria.	Cxbladder Detect-plus performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.	Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the performance characteristics of Cxbladder Triage for subjects with a recent history of microscopic hematuria who are referred to urology and scheduled for cystoscopy for evaluation of microscopic hematuria.	Cxbladder Triage test performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.	Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure

Collaborators and Investigators

• Sponsor: Pacific Edge Limited
• Investigators: Study Chair: Tony Lough, PhD, Pacific Edge (Australia) Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Urothelial Carcinoma; Urine test; genomic test; microscopic hematuria; Cxbladder
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Diseases; Neoplasms, Glandular and Epithelial; Hemorrhage; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma; Carcinoma, Transitional Cell; Hematuria
• Other Study ID Numbers: CXB/2023/microDRIVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be published in an anonymized report once the study is completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No