Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases

Launched by PANGEA LABORATORY LLC · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new urine test called Bladder CARE™ to see how well it can detect bladder cancer in patients who have had unclear results from previous tests, like cytology (looking at cells) or cystoscopy (a procedure to look inside the bladder). The main goal is to find out if this test can help identify bladder cancer in people who are suspected of having it but whose earlier test results were not clear.

To participate in this study, you need to be at least 18 years old and have had inconclusive results from cytology or cystoscopy within the last three months. You'll be asked to provide a urine sample on the same day as your scheduled cystoscopy. The research team will then follow up with you at six months and twelve months to check on your health related to bladder cancer. If you are pregnant, have recently been diagnosed with bladder cancer, or have had certain bladder surgeries, you may not be eligible to join this trial. Overall, this study aims to improve the way bladder cancer is diagnosed, which could lead to better outcomes for patients.

Gender

ALL

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.