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.
Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer
At a glance
Conditions
Where it's being run
8 sites across 4 statesStudy leadership
- Jussi Nikkola · PRINCIPAL_INVESTIGATOR · Tampere University Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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