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

Prior treatment

• Genitourinary manipulation (flexible or rigid cystoscopy, catheterization, urethral dilation, URS, ureteral stent) within 14 days before urine specimen collection.
• 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.
• Patients with a history of NMIBC have undergone intravesical or infusion therapy and completed treatment less than 6 weeks prior to study enrollment.

Other illness

• Positive cystoscopy within 3 months of screening indicating presence of bladder cancer.
• History of augmentation cystoplasty.
• History of continent cutaneous diversion or ileal conduit.
• History of orthotopic bladder substitution or orthotopic neobladder.
• 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.

Other

• Pregnant or planning to become pregnant at the time of screening.

• 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.