Study to Validate Urine DNA Testing as a Possible Replacement for Cystoscopy in Patients Suspected of Urothelial Cancer UROSCOUT-1

What this Trial Is About

Urothelial cancers of the bladder and upper urinary tract cause significant illness and death worldwide, with over 600,000 new cases and 200,000 deaths annually. Patients often present with hematuria blood in urine, leading to many cystoscopiesan invasive bladder examination. However, only about 10% of these cystoscopies result in a cancer diagnosis. This observational study aims to evaluate whether urine tumor DNA utDNA testing can replace many cystoscopies in diagnosing urothelial cancer, potentially improving patient quality of life and reducing healthcare costs and workload in urology centers. The study involves collecting urine samples by mail, which will be analyzed without knowledge of patients cancer status. Patients scheduled for cystoscopy to rule out urothelial cancer will be included, and a random subsampling process will balance cancer-positive and cancer-negative groups. The study will follow patients to compare the sensitivity and specificity of utDNA testing against cystoscopy and urine cytology, assessing the potential to avoid invasive procedures. Participants will provide informed consent and submit urine samples by mail. Researchers will monitor outcomes such as test accuracy, time to diagnosis, adverse events related to cystoscopy, and the number of cystoscopies potentially avoided. Follow-up will extend up to 10 years to evaluate long-term diagnostic outcomes and safety. The study duration includes diagnostic workup and extended monitoring to measure the effectiveness of utDNA testing in clinical practice.

Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer