Urothelial CarcinomaNCT06218433
Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
A study testing Urothelial cancer screening using urine tumor DNA test and Urothelial cancer screening using urine cytology (comparator) in people with Urothelial Carcinoma and Lynch Syndrome, run by Tampere University Hospital at 2 sites in 2 countries.
Trial summary
Lynch syndrome (LS) is an inherited cancer predisposition syndrome caused by pathogenic germline variants in DNA mismatch repair (MMR) genes. New cancer screening and diagnostic tools are urgently needed to identify LS-related cancers early enough for curative treatment. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Urothelial Carcinoma, Lynch Syndrome
- What is being tested?
- Urothelial cancer screening using urine tumor DNA test and Urothelial cancer screening using urine cytology (comparator)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Apr 2023to 31 Dec 2034
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent
- Diagnosis of Lynch syndrome
- Age 50 - 75 years at study recruitment
Who cannot join
- Concurrent urothelial carcinoma
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Canada1 site, 1 recruiting
- Recruiting
Vancouver Prostate Centre
Vancouver
Peter Black
Peter Black
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital and Tampere University
Tampere
Jussi Nikkola
Jussi Nikkola
About this study
Lynch syndrome (LS) is an inherited cancer predisposition syndrome caused by pathogenic germline variants in DNA mismatch repair (MMR) genes. New cancer screening and diagnostic tools are urgently needed to identify LS-related cancers early enough for curative treatment. Urothelial cancers (comprising bladder and upper tract urothelial tumors) are the third most common cancer after colorectal and endometrial cancers in individuals with LS. Up to one in four LS individuals will develop urothelial cancer during their lifetime, with the risk varying based on the defective MMR gene. In this clinical trial, we will employ urine tumor DNA (utDNA) to identify asymptomatic urothelial cancers in Lynch syndrome patients, and to investigate the potential benefits of urine tumor DNA based screening in this high-risk population.
- Conditions
- Urothelial Carcinoma, Lynch Syndrome
- Being tested
- Urothelial cancer screening using urine tumor DNA test, Urothelial cancer screening using urine cytology (comparator)
- Keywords
- Lynch syndrome, Hereditary cancer syndrome, Screening, Urothelial neoplasms, Bladder neoplasms, Upper tract urothelial neoplasms, Urogenital diseases, Liquid biopsies, Urine tumor DNA
- Medical subject headings
- Carcinoma, Transitional Cell, Colorectal Neoplasms, Hereditary Nonpolyposis, Neoplastic Syndromes, Hereditary, Urinary Bladder Neoplasms, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urothelial cancer screening using urine tumor DNA testDiagnostic test
Urine sample DNA is analyzed using a targeted sequencing panel encompassing the coding regions of 21 genes that are recurrently mutated in urothelial cancer
Urothelial cancer screening using urine cytology (comparator)Diagnostic test
Urine cytology sample
| Study group | Role | What they receive |
|---|---|---|
| Screening arm | Experimental | Invitation to participate in urothelial cancer screening and questionnaires Receives: Diagnostic Test: Urothelial cancer screening using urine tumor DNA test; Diagnostic Test: Urothelial cancer screening using urine cytology (comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of positive utDNA for urothelial cancer within one year of follow-up
Sensitivity and specificity of positive utDNA for urothelial cancer, using histologically verified cancers detected within 1 year of the utDNA test as ground truth
Measured: At 1 years of follow-up
Secondary outcomes (10)
Specificity of positive utDNA for urothelial cancer at the time of testing
Specificity of positive utDNA test for urothelial cancer, using histologically verified cancers detected in the cystoscopy and/or imaging performed due to positive utDNA test as the ground truth
Measured: After all patients with positive utDNA have been evaluated with cystoscopy and/or imaging
Sensitivity and specificity of positive utDNA for urothelial cancer within multiple years of follow-up
Sensitivity and specificity of positive utDNA for urothelial cancer, using histologically verified cancers detected within 2, 5, and 10 years of the utDNA test as ground truth
Measured: At 2, 5, and 10 years of follow-up
Overall survival
Overall survival in utDNA positive and negative patients
Measured: At 5 and 10 years of follow-up
Urothelial cancer specific survival
Urothelial cancer specific survival survival in utDNA positive and negative patients
Measured: At 3, 5 and 10 years of follow-up
Time to metastatic urothelial cancer
Time to metastatic urothelial cancer in utDNA positive and negative patients
Measured: At 5 and 10 years of follow-up
Time to diagnosis of muscle invasive or high grade urothelial cancer
Time to diagnosis of muscle invasive or high grade urothelial cancer in utDNA positive and negative patients
Measured: At 2, 5 and 10 years of follow-up
Time to diagnosis of urothelial cancer
Time to diagnosis of urothelial cancer in utDNA positive and negative patients
Measured: At 2, 5 and 10 years of follow-up
TNM pathological stage of urothelial cancers
TNM pathological stage (American Joint Committee on Cancer (AJCC)/International Union Against Cancer (UICC)) of urothelial cancers found in utDNA positive and negative patients
Measured: At 2, 5 and 10 years of follow-up
Size of urothelial tumors
Maximum diameter of urothelial tumors found in utDNA positive and negative patients
Measured: At 2, 5 and 10 years of follow-up
Urothelial cancer grade
The World Health Organization (WHO) 2004/2016 grading of urothelial cancers found in utDNA positive and negative patients
Measured: At 2, 5 and 10 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start10 Apr 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2034 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 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, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218433
- Sponsor's protocol ID
- R22125
- Other IDs
- R22125
- Status last verified
- Nov 2025
- First submitted
- 10 Jan 2024
- Last updated
- 18 Nov 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
- ClinicalTrials.gov ID
- NCT06218433
- Acronym / sponsor ID
- R22125
- Conditions
- Urothelial Carcinoma, Lynch Syndrome
- Keywords
- Lynch syndrome, Hereditary cancer syndrome, Screening, Urothelial neoplasms, Bladder neoplasms, Upper tract urothelial neoplasms, Urogenital diseases, Liquid biopsies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 23 Jan 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.
Lynch syndrome (LS) is an inherited cancer predisposition syndrome caused by pathogenic germline variants in DNA mismatch repair (MMR) genes. New cancer screening and diagnostic tools are urgently needed to identify LS-related cancers early enough for curative treatment. Urothelial cancers (comprising bladder and upper tract urothelial tumors) are the third most common cancer after colorectal and endometrial cancers in individuals with LS. Up to one in four LS individuals will develop urothelial cancer during their lifetime, with the risk varying based on the defective MMR gene. In this clinical trial, we will employ urine tumor DNA (utDNA) to identify asymptomatic urothelial cancers in Lynch syndrome patients, and to investigate the potential benefits of urine tumor DNA based screening in this high-risk population.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening arm | Experimental | Diagnostic Test: Urothelial cancer screening using urine tumor DNA test, Diagnostic Test: Urothelial cancer screening using urine cytology (comparator)Invitation to participate in urothelial cancer screening and questionnaires |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to provide informed consent
- Diagnosis of Lynch syndrome
- Age 50 - 75 years at study recruitment
Key exclusion criteria (1 listed)
- Concurrent 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urothelial cancer screening using urine tumor DNA testUrine sample DNA is analyzed using a targeted sequencing panel encompassing the coding regions of 21 genes that are recurrently mutated in urothelial cancer | Diagnostic test | Screening arm |
| Urothelial cancer screening using urine cytology (comparator)Urine cytology sample | Diagnostic test | Screening arm |
Primary outcome
Sensitivity and specificity of positive utDNA for urothelial cancer within one year of follow-up
Time frame: At 1 years of follow-up
Sensitivity and specificity of positive utDNA for urothelial cancer, using histologically verified cancers detected within 1 year of the utDNA test as ground truth
10 secondary outcomes
Specificity of positive utDNA for urothelial cancer at the time of testing
Time frame: After all patients with positive utDNA have been evaluated with cystoscopy and/or imaging
Sensitivity and specificity of positive utDNA for urothelial cancer within multiple years of follow-up
Time frame: At 2, 5, and 10 years of follow-up
Overall survival
Time frame: At 5 and 10 years of follow-up
Urothelial cancer specific survival
Time frame: At 3, 5 and 10 years of follow-up
Time to metastatic urothelial cancer
Time frame: At 5 and 10 years of follow-up
Time to diagnosis of muscle invasive or high grade urothelial cancer
Time frame: At 2, 5 and 10 years of follow-up
Time to diagnosis of urothelial cancer
Time frame: At 2, 5 and 10 years of follow-up
TNM pathological stage of urothelial cancers
Time frame: At 2, 5 and 10 years of follow-up
Size of urothelial tumors
Time frame: At 2, 5 and 10 years of follow-up
Urothelial cancer grade
Time frame: At 2, 5 and 10 years of follow-up
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 18 Nov 2025.
Related trials for Urothelial Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Registry Platform Urologic Cancer
Renal Cell Carcinoma, Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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, MD, PhD principal investigator
Tampere University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urothelial cancer screening using urine tumor DNA test and Urothelial cancer screening using urine cytology (comparator) in people with Urothelial Carcinoma and Lynch Syndrome, run by Tampere University Hospital at 2 sites in 2 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 3 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Finland. 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 positive utDNA for urothelial cancer within one year of follow-up (time frame: At 1 years of follow-up). 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 18 Nov 2025.