Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria (microDRIVE)
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| ClinicalTrials.gov Identifier: NCT05889195 |
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Recruitment Status :
Recruiting
First Posted : June 5, 2023
Last Update Posted : January 19, 2024
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Sponsor:
Pacific Edge Limited
Information provided by (Responsible Party):
Pacific Edge Limited
| Tracking Information | |||||||||
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| First Submitted Date | May 22, 2023 | ||||||||
| First Posted Date | June 5, 2023 | ||||||||
| Last Update Posted Date | January 19, 2024 | ||||||||
| Actual Study Start Date | November 2, 2023 | ||||||||
| Estimated Primary Completion Date | May 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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.
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria | ||||||||
| Official Title | Validation of Cxbladder Detect-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria (microDRIVE) | ||||||||
| 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. | ||||||||
| 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:
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). |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Urine
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| 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. | ||||||||
| Condition | Urothelial Carcinoma | ||||||||
| Intervention | 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.
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | May 2024 | ||||||||
| Estimated Primary Completion Date | May 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT05889195 | ||||||||
| Other Study ID Numbers | CXB/2023/microDRIVE | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Pacific Edge Limited | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Pacific Edge Limited | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Pacific Edge Limited | ||||||||
| Verification Date | January 2024 | ||||||||