Prospective Validation Study of High Volume Urine DNA Testing in Individuals with Suspicion of Urothelial Cancer
(UROSCOUT-1 Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Jussi Nikkola
Principal Investigator
Tampere University Hospital
Eligibility Criteria
Inclusion Criteria
Treatment Details
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Who Is Running the Clinical Trial?
Tampere University Hospital
Lead Sponsor
Keijo Hämäläinen
Tampere University Hospital
Chief Executive Officer since 2023
PhD in Physics from the University of Helsinki
Pasi Lehto
Tampere University Hospital
Chief Medical Officer since 2023
MD, Professor of Child Psychiatry
Tampere University
Collaborator
Mika Hannula
Tampere University
Chief Executive Officer
D.Sc. in Industrial Engineering and Management
Tapio Visakorpi
Tampere University
Chief Medical Officer since 2022
MD, PhD