UROSCOUT-1: Urine DNA Testing for Urothelial Cancer

This study, called UROSCOUT-1, is looking at a new way to detect urothelial cancer (cancer of the bladder or upper urinary tract) using a urine test. Currently, if you have blood in your urine (hematuria) or other reasons to suspect urothelial cancer, you often need a cystoscopy, which is an invasive procedure. This study wants to see if a urine tumor DNA (utDNA) test can accurately find cancer, potentially reducing the need for many cystoscopies. We are looking for 3000 participants aged 18 to 100 who are scheduled for a cystoscopy to check for urothelial cancer and have not had a prior diagnosis of this type of cancer. The study will measure how well the utDNA test works at detecting cancer one year after your initial diagnostic workup. The study status is currently unclear.

Study design
This is an observational study planning to enroll 3000 participants. It is not a randomized trial.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 1 year after diagnostic workup, suggesting a follow-up period of at least one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06310759

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

Recruiting
Not specifiedAges 18+Observational
Tampere University Hospital
~3,000 participants
Updated 2025-10-10 on ClinicalTrials.gov

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection
Measured over 1 year after diagnostic workup
Urothelial Carcinoma
8 sites across 4 states
Finland5
Illinois1
British Columbia1
Japan1
  • Jussi Nikkola · PRINCIPAL_INVESTIGATOR · Tampere University Hospital

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)
  • Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection1 year after diagnostic workup

    Sensitivity and specificity of utDNA test for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth