New urine test for detecting bladder cancer in unclear cases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: Anderson.Stacy@mayo.edu
• Phone: (507) 293-0432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.