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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Willing and able to provide informed consent
• Patient has been scheduled for cystoscopy to rule out urothelial cancer

🚫 You may not be able to join if…

• Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)

Where this trial is running

• Jesse Brown Department Of Veterans Affairs Medical Center, Chicago, Illinois, United States
• Vancouver Prostate Centre, Vancouver, British Columbia, Canada
• Helsinki University Hospital, Helsinki, Finland
• Satasairaala Hospital, Pori, Finland
• Seinäjoki Central Hospital, Seinäjoki, Finland
• Tampere University Hospital and Tampere University, Tampere, Finland
• Turku University Hospital, Turku, Finland
• Kindai University Hospital, Osaka, Japan

Who to contact

Jussi Nikkola, MD PhD · 03311611 · jussi.nikkola@fimnet.fi

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06310759.