Urothelial CarcinomaUROSCOUT-1NCT06310759
Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer
An observational study of Urothelial Carcinoma, run by Tampere University Hospital at 8 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Urothelial Carcinoma
- How many people
- 3,000 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 8 Jan 2024to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for diagnostic cystoscopy to rule out urothelial cancer due to hematuria, imaging, or urine cytology findings.
Who may be able to join
- Willing and able to provide informed consent
- Patient has been scheduled for cystoscopy to rule out urothelial cancer
Who cannot join
- Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)
Trial locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
Finland5 sites, 5 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Tuomas Jalanko
Riikka Järvinen
- Recruiting
Satasairaala Hospital
Pori
Marjo Seppänen
- Recruiting
Seinäjoki Central Hospital
Seinäjoki
Henry Haapiainen
- Recruiting
Tampere University Hospital and Tampere University
Tampere
Jussi Nikkola
Thea Veitonmäki
- Recruiting
Turku University Hospital
Turku
Pertti Nurminen
Peter Boström
United States1 site, 1 recruiting
- Not yet recruiting
Jesse Brown Department Of Veterans Affairs Medical Center
Chicago, Illinois, 60612
Joel Cornfield
Canada1 site, 1 recruiting
- Recruiting
Vancouver Prostate Centre
Vancouver, British Columbia
Peter Black
Peter Black
Japan1 site, 1 recruiting
- Recruiting
Kindai University Hospital
Osaka
Kazutoshi Fujita
About this study
Official title: 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)
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.
- Conditions
- Urothelial Carcinoma
- Keywords
- Urothelial neoplasms, Bladder neoplasms, Upper tract urothelial neoplasms, Liquid biopsies, Urine tumor DNA
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection
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
Measured: 1 year after diagnostic workup
Secondary outcomes (7)
Sensitivity and specificity of cystoscopy for urothelial cancer detection
Sensitivity and specificity of cystoscopy for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth
Measured: 1 year after diagnostic workup
Sensitivity and specificity of urine cytology for urothelial cancer detection
Sensitivity and specificity or urine cytology for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth
Measured: 1 year after diagnostic workup
Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy
Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy
Measured: 2, 5, and 10 years after diagnostic utDNA testing
Adverse event rate for cystoscopy
Adverse event rate for cystoscopy, based on CTCAE 5.0
Measured: 4 weeks after cystoscopy
Technical success rate of utDNA test
Fraction of all analyzed urine samples for which the analysis met the quality control criteria for a technically successful analysis
Measured: Immediately after utDNA sample analysis
Estimate of diagnostic cystoscopies avoided
Estimated fraction of diagnostic cystoscopies that could have been avoided by pre-screening patients with a utDNA test (calculated as the fraction of all diagnostic utDNA samples that were negative and for which subsequent cystoscopy did not lead to clinical interventions)
Measured: 4 weeks after cystoscopy
Specificity of high-stringency utDNA threshold
Specificity of a high-stringency utDNA threshold (at least 2 known urothelial cancer driver mutations with allele fraction > 5%) for clinically detectable urothelial cancer
Measured: 1 year after diagnostic workup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start8 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Jussi Nikkola, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310759
- Sponsor's protocol ID
- R21088B
- Acronym
- UROSCOUT-1
- Status last verified
- Oct 2025
- First submitted
- 5 Feb 2024
- Last updated
- 10 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06310759
- Acronym / sponsor ID
- UROSCOUT-1 / R21088B
- Conditions
- Urothelial Carcinoma
- Keywords
- Urothelial neoplasms, Bladder neoplasms, Upper tract urothelial neoplasms, Liquid biopsies, Urine tumor DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for diagnostic cystoscopy to rule out urothelial cancer due to hematuria, imaging, or urine cytology findings.
Key inclusion criteria (2 listed)
- Willing and able to provide informed consent
- Patient has been scheduled for cystoscopy to rule out urothelial cancer
Key exclusion criteria (1 listed)
- Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection
Time frame: 1 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
7 secondary outcomes
Sensitivity and specificity of cystoscopy for urothelial cancer detection
Time frame: 1 year after diagnostic workup
Sensitivity and specificity of urine cytology for urothelial cancer detection
Time frame: 1 year after diagnostic workup
Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy
Time frame: 2, 5, and 10 years after diagnostic utDNA testing
Adverse event rate for cystoscopy
Time frame: 4 weeks after cystoscopy
Technical success rate of utDNA test
Time frame: Immediately after utDNA sample analysis
Estimate of diagnostic cystoscopies avoided
Time frame: 4 weeks after cystoscopy
Specificity of high-stringency utDNA threshold
Time frame: 1 year after diagnostic workup
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jussi Nikkola principal investigator
Tampere University Hospital
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Tampere University Hospital at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Finland, United States, Canada, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jussi Nikkola, MD PhD (03311611 ext. +358, jussi.nikkola@fimnet.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection (time frame: 1 year after diagnostic workup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.