Pee test may spare thousands from painful bladder scopes
NCT ID NCT05889195
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study is testing a new, non-invasive urine test called Cxbladder Triage-Plus to see if it can accurately detect bladder cancer in people who have microscopic blood in their urine. Currently, these patients often need a cystoscopy, an invasive procedure where a camera is inserted into the bladder, which can be painful and cause anxiety. The study aims to validate the test's performance in 1,000 participants, potentially offering a simpler and safer way to rule out cancer.
Why investors are watching
Pacific Edge makes Cxbladder, a urine test, and this trial checks whether a version of it can find urothelial carcinoma in people with microscopic hematuria. The company is a micro-cap, so a result that supports the test's accuracy matters a great deal to its business. The trial plans to enroll 1,000 participants.
If it works: A positive result could support Cxbladder Triage-Plus as a non-invasive option for patients who would otherwise need cystoscopy, which may help the company win more use of its test.
If it fails: If the test misses cancers or flags people who are healthy, the result may not support its use, and the company's prospects would suffer. Diagnostic trials often fail to show the accuracy their sponsors hope for.
AI-written from the trial record. Speculative, and not investment advice.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This is a multicenter, observational study prospectively enrolling up to 1000 subjects with microscopic hematuria (three or more red blood cells per high powered field in one urinalysis; no visible blood in the urine) and gross hematuria (visible blood in the urine) from US sites. This study will be conducted on subjects with microscopic or gross hematuria referred to urology and scheduled for cystoscopy for the investigation of urothelial carcinoma.
- Ages
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18 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects who are referred to urology and are either scheduled for a cystoscopy or have had a cystoscopic investigation within the last two months for the evaluation of hematuria meeting ONE of the following criteria: EITHER: (a) Microscopic hematuria, confirmed by urine microscopy of three or more RBC/HPF (or equivalent). OR: (b) Gross hematuria. 2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered. 3. Able to give informed, written consent. 4. 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). 5. Aged 18 years or older. Footnotes: 1. For the microscopic hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder. ii) Patients who are considered high risk by the AUA 2020 guidelines. 2. For gross hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder Exclusion Criteria: 1. Prior history of bladder malignancy. 2. Reported Cxbladder results within the last six months. 3. Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC. 4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch). 5. Subjects aged 89 years of age or older. 6. Subjects with a history of pelvic radiation. 7. Subjects currently receiving systemic chemotherapy or has had systemic chemotherapy within the last six weeks. 8. Subjects with renal failure on dialysis. 9. History of schistosomiasis. 10. Subjects who have had intervention (TURBT, diathermia, etc.,) following a previous cystoscopy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Durham VA Health Care System
Durham, North Carolina, 27705, United States
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The Urology Place
San Antonio, Texas, 78240, United States
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Tri Valley Urology Medical Group
Murrieta, California, 92562, United States
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Other studies related to the condition(s) this trial covers.
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