Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclu… (NCT06870253) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases
United States80 participantsStarted 2025-06-03
Plain-language summary
The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. The main question it aims to answer is:
• Does the Bladder CARE™ Assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results?
Participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. A medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), to document oncology-urinary-related clinical outcomes.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients ≥ 18 years of age at time of informed consent.
. Subject or the subject's legally authorized representative provides written informed consent.
. Subject is willing to follow all study procedures and available for the duration of the study.
. Patients with atypical cytology or equivocal cystoscopy results within 3 months before screening.
. Subject is scheduled for initial or repeat cystoscopy, with or without pathology.
. Subject is willing to provide one voided urine specimen of at least 80 ml on the same day, but prior to scheduled initial or repeat cystoscopy, with or without pathology.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate Bladder CARE™ Assay performance for detecting bladder cancer in patients with atypical cytology or equivocal cystoscopy
Timeframe: From enrollment to the end of the study at 12 months
. Pregnant or planning to become pregnant at the time of screening.
. Positive cystoscopy within 3 months of screening indicating presence of bladder cancer.
. Genitourinary manipulation (flexible or rigid cystoscopy, catheterization, urethral dilation, URS, ureteral stent) within 14 days before urine specimen collection.
. History of augmentation cystoplasty.
. History of continent cutaneous diversion or ileal conduit.
. History of orthotopic bladder substitution or orthotopic neobladder.
. Concomitant use of an investigational drug which has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of urine specimen.
. New or recurrent NMIBC (non-muscle invasive bladder cancer) diagnosis within three months of study enrollment.