Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases
Prospective Evaluation of Bladder CARE™ Assay Utility for the Diagnosis of Bladder Cancer in Patients With Atypical Cytology or Equivocal Cystoscopy
1 other identifier
observational
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2025
CompletedFirst Posted
Study publicly available on registry
March 11, 2025
CompletedStudy Start
First participant enrolled
June 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
January 6, 2026
January 1, 2026
1.7 years
March 5, 2025
January 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate Bladder CARE™ Assay performance for detecting bladder cancer in patients with atypical cytology or equivocal cystoscopy
Assess the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), of the Bladder CARE™ Assay to the gold standard diagnostic methods for detecting bladder cancer in patients with atypical cytology or equivocal cystoscopy results.
From enrollment to the end of the study at 12 months
Eligibility Criteria
Urology practice
You may qualify if:
- 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.
You may not qualify if:
- 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.
- An active malignancy (bladder or other) diagnosis within 3 months of study enrollment.
- Patients with a history of NMIBC have undergone intravesical or infusion therapy and completed treatment less than 6 weeks prior to study enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Biospecimen
Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey R. Karnes, M.D.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2025
First Posted
March 11, 2025
Study Start
June 3, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
January 6, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Beginning 1 year after publication with no end date
- Access Criteria
- Investigators whose proposed use of the data has been approved by an independent review committee and a signed data use agreement
This IPD sharing plan entails sharing de-identified individual participant data (IPD) exclusively through the publication of results from this clinical trial in a reputable medical journal. The shared data will include essential de-identified demographic information such as age, gender, race/ethnicity, clinical outcomes and summary results. Additionally, the performance metrics of the Bladder CARE™ Assay will be disclosed, providing insights into its effectiveness and utility in clinical settings. By disseminating this information through a peer-reviewed journal, we aim to contribute to the scientific community's understanding of the Bladder CARE™ Assay and its implications for patient care, while ensuring that the data is contextualized within the scope of our research findings. This approach aligns with our commitment to transparency and the advancement of medical knowledge. Once accepted, the article will be published.