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Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer
Observational Prospective Multicenter Validation Study Investigating the Possibility of Replacing Cystoscopies With High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer (UROSCOUT-1)
Who can join
Ages 18 to 100 · All sexes
Full eligibility criteria
Inclusion Criteria: * Willing and able to provide informed consent * Patient has been scheduled for cystoscopy to rule out urothelial cancer Exclusion Criteria: * Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)
About the study
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.
Sponsor: Tampere University Hospital · Participants: 3,000 · Started: Jan 8, 2024
Contact the study team
- Jussi Nikkola, MD PhD · Phone: 03311611
Official record on ClinicalTrials.gov — NCT06310759
Locations in the U.S.
| Illinois | Jesse Brown Department Of Veterans Affairs Medical Center, Chicago (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.