Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

Part of paid clinical trials in Murrieta, California.

Sponsor
Pacific Edge Limited
Study ID
NCT05889195
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Cxbladder urine test — DIAGNOSTIC_TEST
    Cxbladder tests uses mRNA and DNA biomarkers in the urine to direct the management of UC from diagnosis to surveillance for disease recurrence.

Study Details

It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen with 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 cystoscopy can cause anxiety and pain, in addition to other potential side effects. This has resulted in low admittance for cystoscopy among patients with hematuria (blood in urine) in urology clinics. Therefore, there is a need for a simpler, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. Cxbladder, a non-invasive, urine-based test, has the potential to fill this role.

Key Dates

Start date
Nov 2, 2023
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

To validate the performance characteristics of Cxbladder Triage Plus in a US cohort which will consist of subjects with a recent history of hematuria and are referred to urology and scheduled for cystoscopy for the evaluation of 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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Tri Valley Urology Medical GroupMurrietaCalifornia92562
Anita Deeds
[email protected]
(951) 698-1901
Varun Talanki (PRINCIPAL_INVESTIGATOR)
AccuMed Research AssociatesGarden CityNew York11530
Leanne Cossu
[email protected]
516-746-2190
Mitchell Efros (PRINCIPAL_INVESTIGATOR)
Durham VA Health Care SystemDurhamNorth Carolina27705
Ally Shelley
[email protected]
+1 919 286 0411
Aubrey Jarman
[email protected]
+1 919-286 0411
Stephen Freeland (PRINCIPAL_INVESTIGATOR)
The Urology PlaceSan AntonioTexas78240
Raji Thiruppathiraj
[email protected]
210-617-3670
Dr. Naveen Kella
[email protected]
210-809-4440
Naveen Kella (PRINCIPAL_INVESTIGATOR)

Find similar trials in Murrieta, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Tri Valley Urology Medical Group· Murrieta, CAAccuMed Research Associates· Garden City, NYDurham VA Health Care System· Durham, NCThe Urology Place· San Antonio, TX

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