Urine test could spare bladder cancer patients from painful scopes
NCT ID NCT05796375
First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 5 times
Summary
This study tests whether a simple urine test (Bladder EpiCheck) can safely replace some of the invasive cystoscopy procedures used to monitor non-muscle invasive bladder cancer. About 240 adults with low-grade intermediate-risk bladder cancer will be followed to compare quality of life, discomfort, anxiety, and cancer outcomes between those who get standard cystoscopies and those who get urine tests instead. The goal is to see if monitoring can be made less burdensome without missing cancer recurrences.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bladder EpiCheck urine test
- What this could lead to
- If successful, this could make bladder cancer monitoring less invasive and more comfortable, reducing the need for frequent cystoscopies.
- What could go wrong
- This is a Phase 2 trial with 240 participants, so results are preliminary. The urine test may not catch all recurrences, and some cystoscopies may still be needed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 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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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- 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. Aged 18 years or older 2. History of low grade intermediate-risk non-muscle invasive bladder cancer, defined as most recent pathology report showing any of the following: * multifocal low grade non-invasive urothelial carcinoma of any size * solitary low grade non-invasive urothelial carcinoma greater than 3cm in size * recurrent low grade non-invasive urothelial carcinoma 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. No evidence for recurrence at cystoscopy ≤6 months after most recent tumor resection 5. Ability to consent in English or Spanish Exclusion Criteria: 1. History of total cystectomy of the bladder. 2. History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit). 3. History of muscle-invasive bladder tumor. 4. Pregnancy or lactation. 5. History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of recurrent upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion) 6. Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture). 7. Inability to provide a voided urine sample.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Bay Pines VA Healthcare System
RECRUITINGBay Pines, Florida, 33744, United States
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Dartmouth Hitchcock Medical Center
RECRUITINGLebanon, New Hampshire, 03756, United States
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James A. Haley Veterans' Hospital
WITHDRAWNTampa, Florida, 33612, United States
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Medical University of South Carolina
ACTIVE_NOT_RECRUITINGCharleston, South Carolina, 29425, United States
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UT Southwestern Medical Center
RECRUITINGDallas, Texas, 75235, United States
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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VA Boston Jamaica Plains Campus
RECRUITINGWest Roxbury, Massachusetts, 02132, United States
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VA St.Louis Healthcare System
RECRUITINGSt Louis, Missouri, 63016, United States
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West Haven VA Medical Center
RECRUITINGWest Haven, Connecticut, 06516, United States
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White River Junction Veterans Healthcare System
RECRUITINGWhite River Junction, Vermont, 05009, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can heated saline during bladder surgery stop tumors from coming back?
- Radiation instead of bladder removal: a new option for Hard-to-Treat bladder cancer?
- Can an immunotherapy plus chemotherapy keep High-Risk bladder cancer at bay?
- Can a bladder rinse before surgery keep bladder cancer at bay?
- Timing chemotherapy around bladder surgery may cut recurrence