New urine test for detecting bladder cancer in unclear cases

Prospective Evaluation of Bladder CARE™ Assay Utility for the Diagnosis of Bladder Cancer in Patients With Atypical Cytology or Equivocal Cystoscopy

This study is testing a new urine test to see if it can help find bladder cancer in patients who have unclear test results.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Pangea Laboratory LLC (industry)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT06870253 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness of the Bladder CARE™ Assay in detecting bladder cancer in patients who have inconclusive cytology or cystoscopy results. Participants will provide a urine sample on the day of their scheduled cystoscopy, and their medical records will be reviewed at 6 and 12 months to assess clinical outcomes related to bladder cancer. The study aims to determine if this non-invasive test can improve detection rates in challenging cases.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with atypical cytology or equivocal cystoscopy results who are scheduled for cystoscopy.

Not a fit: Patients who have had a positive cystoscopy indicating bladder cancer within the last 3 months or those who have undergone recent genitourinary manipulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this test could provide a more accurate and non-invasive method for detecting bladder cancer in patients with unclear diagnostic results.

How similar studies have performed: Other studies have shown promise in using non-invasive urine tests for bladder cancer detection, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients ≥ 18 years of age at time of informed consent.
2. Subject or the subject's legally authorized representative provides written informed consent.
3. Subject is willing to follow all study procedures and available for the duration of the study.
4. Patients with atypical cytology or equivocal cystoscopy results within 3 months before screening.
5. Subject is scheduled for initial or repeat cystoscopy, with or without pathology.
6. 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:

1. Pregnant or planning to become pregnant at the time of screening.
2. Positive cystoscopy within 3 months of screening indicating presence of bladder cancer.
3. Genitourinary manipulation (flexible or rigid cystoscopy, catheterization, urethral dilation, URS, ureteral stent) within 14 days before urine specimen collection.
4. History of augmentation cystoplasty.
5. History of continent cutaneous diversion or ileal conduit.
6. History of orthotopic bladder substitution or orthotopic neobladder.
7. 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.
8. New or recurrent NMIBC (non-muscle invasive bladder cancer) diagnosis within three months of study enrollment.
9. An active malignancy (bladder or other) diagnosis within 3 months of study enrollment.
10. Patients with a history of NMIBC have undergone intravesical or infusion therapy and completed treatment less than 6 weeks prior to study enrollment.

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Jeffrey R. Karnes, M.D. — Mayo Clinic
• Study coordinator: Stacy R Anderson, R.N.

Conditions: Bladder Cancer, Urothelial Carcinoma Bladder, Bladder CARE™, Atypical Cytology, Equivocal Cystoscopy, Bladder Cancer Detection, Hematuria, Non-Invasive Urine Test