Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer - Trial NCT06310759

Timeline & Enrollment

Primary Outcome

Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection

Summary

Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and
 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood
 in urine), triggering a cascade of tests, including an invasive examination of the bladder
 using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year
 worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis.
 The UROSCOUT-1 trial is a prospective multicenter observational study that explores the
 potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies
 in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The
 goal is to enhance patient quality of life, reduce healthcare costs, and address increased
 workloads in urology centers. Sample collection will be conducted by mail, and the samples
 will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with
 cancer. Random subsampling will be applied to cancer-negative patients to achieve an
 approximate 1:1 ratio between cancer-positive and -negative patients.

ICD-10 Classifications