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

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ClinicalTrials.gov Identifier: NCT05889195
Recruitment Status : Recruiting
First Posted : June 5, 2023
Last Update Posted : January 19, 2024
Sponsor:
Information provided by (Responsible Party):
Pacific Edge Limited

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Urothelial Carcinoma 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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of Cxbladder Detect-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria (microDRIVE)
Actual Study Start Date : November 2, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Cxbladder urine test
    Cxbladder tests uses mRNA and DNA biomarkers in the urine to direct the management of UC from diagnosis to surveillance for disease recurrence.

Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure ]
    Cxbladder Detect-plus performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.


Secondary Outcome Measures :
  1. 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. [ Time Frame: Baseline, pre-intervention / procedure (cystoscopy): Each subject is scheduled for cystoscopy and provides one urine sample for the Cxbladder test pre-procedure ]
    Cxbladder Triage test performance will be measured using performance characteristics such as sensitivity, specificity, negative predictive value and positive predictive value.


Biospecimen Retention:   Samples With DNA
Urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05889195


Contacts
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Contact: Ash Maharjan, PhD +64 27 318 0613 ash.maharjan@pelnz.com
Contact: Alexis White, BSc (Hons) +64 21 959 001 alexis.white@pelnz.com

Locations
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United States, North Carolina
Durham VA Health Care System Recruiting
Durham, North Carolina, United States, 27705
Contact: Ally Shelley    919-286-0411    Mary.shelley@va.gov   
Contact: Meredith Muller    +1 931 309 2792    meredith.muller@va.gov   
Sponsors and Collaborators
Pacific Edge Limited
Investigators
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Study Chair: Tony Lough, PhD Pacific Edge (Australia) Pty Ltd
More Information
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Responsible Party: Pacific Edge Limited
ClinicalTrials.gov Identifier: NCT05889195    
Other Study ID Numbers: CXB/2023/microDRIVE
First Posted: June 5, 2023    Key Record Dates
Last Update Posted: January 19, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published in an anonymized report once the study is completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pacific Edge Limited:
Urothelial Carcinoma
microscopic hematuria
Cxbladder
Urine test
genomic test
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Hematuria
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urination Disorders
 Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Hemorrhage
Pathologic Processes