NCT03988309Completed
STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA
Use of a Multiplexed Molecular Biomarker Test Cxbladder, in Real World Decision Making to Provide Clinical Utility Using a Randomized Design ("STRATA Study")
Source: ClinicalTrials.gov · Last updated 31 May 2025
Brief summary (registry, in English)
To evaluate the clinical utility associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of urothelial carcinoma (UC) without compromising detection of UC.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 554 (actual)
- First submitted
- 24 Apr 2019
- Start date
- 11 Sept 2019
- Primary completion date
- 24 Jul 2024
- Lead sponsor
- Pacific Edge Limited
- Diseases
- Bladder cancer
- NCT number
- NCT03988309
What you commit to
- Study type: Interventional
- Participants enrolled: 554
- From 11 Sept 2019 to the primary completion date, 24 Jul 2024
- 12 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of bladder malignancy or pelvic radiotherapy. Prior history prostate or renal cell carcinoma within the last 5 years.
- Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,
Other
- Known current pregnancy
Who the study is looking for
- Patient is undergoing investigation of recent confirmed hematuria, as defined by the AUA/SUFU Guideline (Barocas DA, Boorjian SA, Alvarez RD et al. Microhematuria: AUA/SUFU guideline, J Urol 2020; 204:778) (by either flexible or rigid cystoscopy/TURBT), including hematuria subjects referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.
- Able to provide a voided urine sample of the required minimum volume
- Able to give written consent
- Able and willing to comply with study requirements
- Aged 18 years or older
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre · Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| The prostate centre- Diamond Health care centre Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Accellacare Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Division of urology, Penn State Milton S Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Institute of Urology, USC Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Allina Health Cancer Institute Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| University of Minnesota, Department of Urology Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Carolina Urologic Research Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| Department of Urology,Vanderbilt University Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| UTHSA - Mays Cancer Center Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Avant Concierge Urology Coordinator of this site? Confirm its status | Winter Garden | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.